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Avance Clinical Client Atossa Therapeutics Completes Enrollment of Phase 1 Clinical Study of AT-301 Nasal Spray Being Developed for the Coronavirus Causing COVID

By Client News, Company NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical is pleased to share the news that their client Atossa Therapeutics (NASDAQ: ATOS) has announced completion of enrollment in its Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray for the treatment of COVID-19. AT-301 is being developed for at home use enabling management of the infection symptoms with at home quarantine and potentially preventing disease progression.

Avance Clinical Chief Scientific Officer Gabriel Kremmidiotis PhD, BSC Hon said:

“With a number of countries around the globe currently experiencing secondary waves of COVID-19 infection spread, the need for vaccines and therapies is significant and the ability to deliver fast start-up and execution of clinical trials to expedite development of such products, like AT-301, is essential. Avance was able to deliver start-up and execution of the AT-301 trial in record time. We have a very experienced team who worked effectively with Australian Human Research Ethics and a dedicated Phase I unit based here in South Australia in delivering this great result for Atossa.”

According to Atossa Therapeutics:

Atossa Therapeutics, Inc., a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, announced it has now completed enrollment in its Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray.

“Completing enrollment is a significant milestone and comes at a time when we are seeing a new wave if infections in certain geographies and an increased focus on developing therapies to treat COVID-19,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO. “While the virus presents significant danger overall, the vast majority of people testing positive for COVID-19 do not require hospitalization and instead quarantine at home while they manage their symptoms and attempt not to infect those around them. As there are no currently FDA-approved treatments to help these patients, we are developing AT-301 for at home use so that they can recover faster.”

Atossa plans to identify potential partners who are developing COVID-19 diagnostic tests so that AT-301 nasal spray may be co-developed and commercialized with the goal of making the AT-301 therapy available at the time a person tests positive for the coronavirus. Atossa also plans to develop its nasal spray to potentially help prevent COVID-19 infection — particularly for people in high risk environments — including, for example, people living with a patient infected with COVID-19, healthcare workers, emergency responders and teachers. In addition to seeking a partner, Atossa’s next steps with this program include contracting for a commercial supply of the nasal spray devices; reporting preliminary top line results from the Phase 1 study; and completing regulatory filings and any necessary approvals to launch a Phase 2 study, which it is planning for the first half of 2021.

The ongoing Phase 1 study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups. Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A at two different doses. Part B is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two different doses. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives are to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation. The study is being conducted in Australia.

ABOUT ATOSSA THERAPEUTICS

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

See full announcement here.

Avance Clinical Wins MasterControl 2020 Innovation Excellence Award

By Company Awards, Company NewsNo Comments

The leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical today accepted the MasterControl 2020 Innovation Excellence Award in a virtual ceremony.

Avance Clinical made the announcement today at AusBiotech 2020 (28 – 30 October, 2020).

Avance Clinical CEO Yvonne Lungershausen said the company was very pleased to be awarded such recognition by MasterControl, a leader in the clinical digital management technology.

 

“The award acknowledges our leadership as Australia’s biotech CRO and it provides further confidence to our clients that we are serious about delivering quality clinical research services by being nimble and adaptive, and by utilising state-of-the-art systems that are compliant with industry standards, such as MasterControl eQMS,” said Yvonne Lungershausen.

“Avance Clinical invests significantly in the industry’s leading clinical technologies making it one of the most advanced CROs globally for digital clinical research management and eClinical solutions.”

On presenting the Innovation Excellence Award, MasterControl said the award recognises “the power of innovation and celebrates companies who feel the same way we do, who are not afraid to shed the status quo to find their own path and who push boundaries and spearhead important changes within their industries. Companies driven by innovation who truly live and breathe it.”

Avance Clinical Director Quality Assurance, Priyanka Chamoli, said:

“Receiving the award from MasterControl is a testament of our commitment to invest in our Quality Management System and to continually improve and strengthen it. This Award recognises and provides visibility to our efforts to push boundaries and adopt this significant change not just for the Quality Assurance department but across-the-board in the organisation.”

“MasterControl eQMS enables accurate, streamlined processes for Document Control and Training. Avance Clinical, which is on a significant growth trajectory, requires robust procedures as part of our QMS. MasterControl has allowed our staff to create/review and access our controlled documents in real-time and the automated link between different modules enables timely delivery of training.”

Avance Clinical Director Compliance and Training, Lisa Eglinton said:

“MasterControl Training Module provides a robust, user-friendly method for the delivery of role-specific training programs to all staff.  The system provides a real-time indication of training status to Trainees and their Line Managers which ensures training compliance across the company.”

Avance Clinical is the leading Australian owned CRO that has been providing high-quality clinical research services fit for global regulatory standards to the local and international drug development industry for 20 years.

Considering Australia? Contact us about your next study.

(From left to right) Priyanka Chamoli, Director Quality Assurance, Emma Woolman, Senior Compliance and Training Officer,  Yvonne Lungershausen, Avance Clinical’s CEO, and Lisa Eglinton, Director Compliance and Training.

Biotechs get scalable early to late phase clinical offering from Cromos Pharma and Avance Clinical collaboration in Australia and Europe

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Dublin/Ireland – Adelaide/Australia – Two dominant regional contract research organizations (CRO), Avance Clinical and Cromos Pharma, with operations in Australia and Central/Eastern Europe, respectively, are successfully collaborating on a scalable clinical solution for biotechs.

The collaboration allows biotechs to quickly start their pre-IND early phase studies in Australia, then expand to Central/Eastern Europe to access the large patient populations for their Phase 2 and 3 studies.

Importantly, the AU/EU model allows biotechs to keep their data and trial management in Australia, and take advantage of the Australian cash rebate of up to 43.5% on clinical trial costs, throughout all study phases, across both regions.

“We are very excited about this model that seamlessly incorporates two of the most compelling and complementary international clinical research hubs for our biotech clients from early to late phase studies,” said Yvonne Lungershausen, CEO of Avance Clinical. “Our eClinical and early phase expertise is well augmented by Cromos Pharma’s track record in late stage trials and rapid enrollment capabilities,” she continued.

“We have been collaborating with Avance Clinical and referring clients to each other for years,” remarked Vlad Bogin, CEO of Cromos Pharma. “But it was a true Eureka moment when we realized that combining Australia’s 43.5% tax rebate with Central/Eastern Europe’s unbeatable recruitment rates is a paradigm shift in how clinical trials should be conducted,” he concluded.

Cromos Pharma can access hundreds of millions of patients via more than 2,500 sites in Central/Eastern Europe.

Ends

About Cromos Pharma www.cromospharma.com

Cromos Pharma provides tailored and effective clinical trial solutions to support the development of drugs that transform healthcare. An international CRO with over 15 years’ experience, we offer fully integrated services performing all aspects of clinical trials in all clinical phases and in a wide range of therapeutic areas. Cromos Pharma delivers rapid recruitment and excellent patient retention as well as expert study design and management. Cromos Pharma has strong regional experience in Central and Eastern Europe with global coverage provided by its US bases in Portland, Oregon and Miami, Florida. Cromos Pharma’s European HQ is in Dublin, Ireland. At Cromos Pharma, we know how important your product is. When the stakes are this high, you need a high-performance partner.

Key benefits:

  • International expertise combined with in-depth regional knowledge in Central and Eastern Europe (300+ clinical trials conducted in 70+ indications).
  • Extensive PI/site and patient network (40,000+ patients enrolled from nearly 2,500 trial sites).
  • Unparalleled patient recruitment – our team met or shortened project timelines in 95% of conducted trials.
  • Responsible recruitment is supported by Cromos Pharma’s “No Patients-No Payments” initiative – a unique risk-sharing program.
  • Extremely short startup timelines (e.g. Georgia where we assure a study launch in less than 2 months).
  • Expertise in innovative, generics and biosimilar global studies (NDAs, ANDAs, BLAs, 505b2).
  • Regulatory inspections and audits that attest to the highest quality of data: EMA in 2019 (1-week oncology site inspection); FDA in 2017 (2-week oncology site inspection).
  • Clinical Development Strategy – we provide expert guidance on study design, favorable venues, local and global landscape to improve study outcomes.

Avance Clinical Announces Expanded eClinical Solutions for Biotech Clinical Trials at BioPharm America

By Company News, Conference News, Partner NewsNo Comments

The leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical has expanded its eClinical solutions offering, with advanced digital clinical tools for enhanced patient engagement, visibility, data capture, and analysis. www.avancecro.com/eclinical-solutions

Avance Clinical made the announcement at BioPharm America (September 21-24, 2020)

Avance Clinical’s biotech clients now have the option to deploy the latest eClinical solutions to maximise the value of study data and deliver real-time visibility on study progress.

Avance Clinical CEO Yvonne Lungershausen said:

“Our Data Management team works with eClinical leaders such as Medrio to offer regulatory compliant and patient-centric tools for rapid start-up and continual data flow.

These tools improve patient engagement and data collection and allow Sponsors to stay informed at every step with Sponsor visible portals.”

The Avance Clinical eClinical services include the following:

eSource

  • Direct data capture of source data on site
  • Forms customised by Avance Clinical Data Management team
  • Edit checks built into forms; instant firing of queries once data is entered
  • Option for data to be collected off-line and synced when on-line is available
  • Fully integrated with Medrio EDC, data visible for Sponsor review instantly
  • Remote monitoring and data review on ongoing basis
  • Avance Clinical provision of tablets if required


eConsent

  • Electronic consent including patient sign-off and investigator confirmation
  • Customisable to include animations, videos and questions as required
  • Forms customised by Avance Clinical Data Management team
  • Link via email to patient
  • Compatible with any device and internet system (smart phones, tablet, laptop, desktop)
  • Integrated with Medrio EDC
  • Link can be shared with HREC as part of submission package


ePRO

  • Electronic capture of patient-reported outcome, including diary data, dosing compliance, questionnaires, VAS/Pain scales
  • Forms customised by Avance Clinical Data Management team
  • Link via email to patient
  • Options for emails and reminders at set times during the day or week
  • Timezone adjusted to patient’s location
  • Compatible with any device and internet system (smart phones, tablet, laptop, desktop)
  • Fully integrated with Medrio EDC, data visible for Sponsor review instantly

Glynn Morrish, Avance Clinical Director Biometrics said:

“Direct electronic capture of study information and the complimentary suite of solutions offered by Avance Clinical allows the company and its clients to maximise clinical trial efficiency and flexibility while ensuring data integrity is preserved.

Our highly trained and experienced biometrics team are excited to continue to work at the forefront of innovation and technology and provide services that offer stability and robustness to studies being conducted in an ever-changing global environment.”

Avance Clinical is an Australian-owned Contract Research Organisation that has been providing high-quality clinical research services fit for global regulatory standards to the local and international drug development industry for 20 years.

News: Jorgen Mould PhD, BSc (Hons) joins Avance Clinical as Scientific Affairs Specialist

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The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical is pleased to announce the appointment of Jorgen Mould PhD, BSc (Hons) as Scientific Affairs Specialist.

Jorgen has over 23 years of experience in medical research and drug development.

With a passion for developing new treatments for human diseases, Jorgen has worked in positions that span the full spectrum of a drug lifecycle from bench side discovery to post-market approval.

Prior to joining Avance Clinical, Jorgen worked in the Neurology Medical team at Merck Healthcare where his background in neuroimmunology and neuroinflammatory disorders was used to build strong scientific partnerships with key external stakeholders.

During this time, Jorgen also gained considerable knowledge of late-phase clinical development and regulatory submission. Prior to this, Jorgen was Director of Ion Channel Biology at Bionomics Limited, where he was responsible for leading the pre-clinical development of small molecule therapeutics for Multiple Sclerosis and Chronic pain.

Other notable career highlights include 5 years postdoctoral work in the department of Neurobiology at Northwestern University, Chicago working on Influenza Virus and a 3-year appointment at the Institute for Molecular Biosciences at the University of Queensland identifying novel peptides as pain therapeutics.

Jorgen has a PhD in medical sciences from the John Curtin School of Medical Research at the Australian National University and a Bachelor of Science (Hons) majoring in Biochemistry from the University of Queensland. Jorgen has published several peer-reviewed articles in prominent scientific journals and has contributed to numerous patents relating to small molecule therapeutics for the treatment of multiple sclerosis and chronic pain.

Avance Clinical Client Immunic, Inc. Announced Dosing of First Healthy Volunteer in Phase 1 Clinical Program of IMU-856, Targeting Restoration of Intestinal Barrier Function

By Client News, Company NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical is pleased to share the news that its client Immunic Therapeutics has announced dosing of the first healthy volunteer in the company’s phase 1 clinical program of IMU-856, an novel treatment for patients suffering from gastrointestinal diseases, including diarrhea-predominant irritable bowel syndrome, ulcerative colitis and Crohn’s disease.

Immunic Therapeutics (Nasdaq: IMUX) isa clinical-stage biopharmaceutical company developing selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases.

According to the public announcement released by Immunic Therapeutics on 20 August 2020:

  • IMU-856, an orally available, small molecule modulator, serves as a transcriptional regulator of intestinal barrier function. Based on preclinical data, the compound appears to represent a novel and potentially paradigm-shifting approach to the treatment of gastrointestinal diseases by potentially restoring intestinal barrier function while maintaining immunocompetency.
  • Immunic’s Australian subsidiary, Immunic Australia Pty Ltd., received approval from the Bellberry Human Research Ethics Committee in Australia to conduct a phase 1 clinical trial of IMU-856 under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutic Goods Administration (TGA). The phase 1 clinical program includes single and multiple ascending dose parts in healthy volunteers. Subsequently, Immunic also plans to extend this program to assess biomarker, safety and drug trough levels in patients with diarrhea-predominant irritable bowel syndrome, ulcerative colitis and Crohn’s disease.

Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, noted, “Current treatments for many gastrointestinal conditions focus on inhibiting inflammation and do not directly address impaired intestinal barrier function. In contrast, IMU-856 appears to have a unique targeted ability to strengthen and thereby normalize this function, potentially avoiding the bacterial triggers which can occur when the intestinal barrier is impaired. Moreover, because this approach appears to avoid any detrimental effects on the immune system, we believe that IMU-856 has the potential to change the treatment paradigm for gastrointestinal diseases.”

Avance Clinical Chief Scientific Officer Gabriel Kremmidiotis PhD, BSC Hon said “We consider ourselves fortunate to be working with Immunic on this exciting project. IMU-856 is the second compound that Immunic has selected Avance Clinical as their CRO. Our engagement in these projects has been from early planning, study design, preparation of the investigator brochures and clinical trial protocols. Working with the Immunic team and the Bellberry Human Research Ethics Committee, we have been able to design clinical trials which include careful data informed adaptive elements aimed at expediting the transition of these promising products from healthy volunteers to the patient populations.”

See full announcement here: https://www.immunic-therapeutics.com/2020/08/20/immunic-inc-announces-dosing-of-first-healthy-volunteer-in-phase-1-clinical-program-of-imu-856-targeting-restoration-of-intestinal-barrier-function/

About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn’s disease, and psoriasis. Immunic is developing three small molecule products: its lead development program, IMU-838, is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect; IMU-935 is an inverse agonist of RORγt; and IMU-856 targets the restoration of the intestinal barrier function. On August 2, 2020, Immunic announced positive top-line results from its phase 2 EMPhASIS trial of IMU-838 in patients with relapsing-remitting multiple sclerosis, reporting achievement of both primary and key secondary endpoints with high statistical significance, indicating activity for IMU-838 in this indication. IMU-838 is also in phase 2 clinical development for ulcerative colitis and COVID-19, with an additional phase 2 trial considered in Crohn’s disease. An investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis is ongoing at the Mayo Clinic. For further information, please visit: www.imux.com.

Avance Clinical Client Atossa Therapeutics Announces Enrollment and Dosing Completed in First Group of Healthy Participants in Clinical Study of AT-301 Nasal Spray Being Developed for Treatment of COVID-19

By Client News, Company NewsNo Comments

 

The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical is pleased to share the news that Atossa Therapeutics have enrolled and dosed the first cohort of healthy participants at CMAX Clinical Research in the Phase 1 clinical study using its proprietary drug candidate AT-301, being administered by nasal spray.

According to Atossa Therapeutics:

Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, today announced that it has enrolled and dosed the first cohort of healthy participants in the Phase 1 clinical study using its proprietary drug candidate AT-301, being administered by nasal spray. This group of 8 participants received a single dose of either AT-301A (placebo) or AT-301B (active).

“Advancing our COVID-19 drug candidates through clinical studies as quickly as possible is our highest priority,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO.

“We are very encouraged by the high level of interest in this study and the speed at which we enrolled this first group of participants. Our novel nasal spray drug candidate is being developed to provide a unique protective mucosal barrier with anti-viral properties within the nasal cavity, hopefully leading to lower infectivity and reduced symptoms in COVID-19 patients. If this can slow virus proliferation sufficiently to allow the patient to mount a strong, natural immune response AT-301 could significantly impact the current public health options for controlling COVID-19. We look forward to quickly completing enrollment of all cohorts in this potentially important study.”

The study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups. Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A at two different doses. Part B is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two different doses. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives are to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation. The study is being conducted in Australia.

Avance Clinical Chief Scientific Officer Gabriel Kremmidiotis PhD, BSC Hon said:

‘It is a privilege to have been selected by Atossa Therapeutics to manage their AT-301 nasal spray for COVID-19 clinical trial. This study is the latest addition to a number of studies that Avance Clinical has been managing for Atossa Therapeutics over the past 5 years. Our relationship with Atossa Therapeutics epitomises  Avance Clinical’s  service model where our team become part of the client’s drug development team, executing clinical development  with the big picture in mind, assisting our clients to achieve their goals across their whole product pipeline and not just delivering transactional clinical trial management.’

Adelaide, Australia-based CMAX Clinical Research is also part of the study and Jane Kelly, CEO at CMAX Clinical Research said, “I am excited to be at the forefront with Avance Clinical supporting Atossa Therapeutics develop a COVID treatment. South Australia was able to move quickly through ethics and get our first participant dosed at a record pace”.

ABOUT ATOSSA THERAPEUTICS

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

See full announcement here https://atossatherapeutics.com/atossa-therapeutics-announces-enrollment-and-dosing-completed-in-first-group-of-healthy-participants-in-clinical-study-of-at-301-nasal-spray-being-developed-for-treatment-of-covid-19/

Avance Clinical Joins Medrio’s ‘Trial Talks’ Podcast about Why Clinical Trials are Thriving in Australia

By Company News, Partner NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical, joins Medrio’s new podcast series Trial Talks (listen here https://medrio.com/podcast/why-clinical-trials-are-thriving-in-australia/).

Medrio, Inc. is the leading provider of eClinical technology to pharmaceutical, biotech, medical device, diagnostics, and animal health markets. The first of the new Trial Talks podcast series features Avance Clinical CEO Yvonne Lungershausen and Director of Business Development Operations Sandrien Louwaars interviewed by Mike Novotny, CEO at Medrio.

Trial Talks is a clinical trials podcast series hosted by Medrio thought leaders. Trial Talks season one will focus on industry trends and challenges, unique solutions, and the perseverance of the industry through one of our toughest challenges, COVID-19.

Trial Talks season 1, episode 1 “Why Clinical Trials are Thriving in Australia” focuses on how Avance Clinical prepared for the pandemic, what tools were leveraged that allowed trial continuation, and why clinical trials are currently thriving in the region.

Medrio and Avance Clinical recently reached a milestone of supporting 150 clinical trials together.

Medrio and Avance Clinical’s successful partnership began in 2012 on a Phase I study with 103 patients and 14 sites, with Avance Clinical being Medrio’s first CRO partner in the Asia-Pacific.

Avance Clinical has utilized Medrio’s electronic data capture (EDC) solution successfully for the past eight years supporting 158 Phase I studies, 6,047 patients, and 236 sites. The HRECs usual review cycle in Australia, which takes only 4 to 8 weeks, coupled with Medrio’s ability to achieve FPI in less than three weeks is a perfect combination for accelerating study starts, a critical component to Phase I trials.

Yvonne Lungershausen, CEO at Avance Clinical said:

“Medrio has always been a wonderful partner to Avance Clinical. In addition to their EDC, we’ve used their ePRO and Direct Capture solutions, and we’re always impressed by not only their speed and flexibility but also their support. We know that if we have a question or need assistance that it will be addressed immediately and resolved quickly. Our partnership continues to flourish through ongoing clinical trials. We also recently had a great conversation with Medrio on their podcast, Trial Talks, about Australia’s unique position in the midst of COVID-19. I look forward to the continued success and growth of our partnership.”

Mike Novotny, CEO Medrio said:

“I’ve always been data-driven, and reaching the 150 trials milestone speaks volumes about Medrio and Avance’s relationship. Trust is earned, and I’d like to think that we’ve shown that we offer not only sophisticated clinical trial technology but also pride in our work. Our support team is available 24/7 and I am always proud to hear our customers speak so highly of them.

At Medrio we always have the patients in mind, and the faster we can get a trial up and running or provide support, the faster the patients in need will have the drugs, therapies, or devices that they need. I enjoyed interviewing Yvonne Lungershausen (CEO) and Sandrien Louwaars (Director of Business Development Operations) for the first Trial Talks podcast episode. It was fascinating to hear how Australia and New Zealand are operating in the midst of a global pandemic, and it highlights the perseverance of the industry and the Golden Age of pharma.”

About Medrio
Medrio is the leading provider of eClinical technology for pharma, device, and diagnostics clinical trials. Founded in 2005, the company’s cloud-based EDC, Direct Data Capture, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient-reported outcome responses. Study sponsors and Contract Research Organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. For more information, please visit http://www.medrio.com.

Avance Clinical Contracted for Atossa Therapeutics AT-301 Nasal Spray Clinical Study, Atossa’s Second COVID-19 Therapeutic Development Program

By Client News, Company NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been contracted to conduct a clinical study of Atossa Therapeutics’ proprietary drug candidate AT-301, to be administered by nasal spray. Avance has successfully completed multiple clinical studies of Atossa’s proprietary Endoxifen.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19.

Yvonne Lungerhausen, CEO, Avance Clinical said:

“Avance Clinical is very pleased to be working with Atossa Therapeutics again on their second COVID-19 Therapeutic Development Program. Atossa is a valued long-term client that clearly understands the excellence in clinical research available in Australia, and the many benefits of conducting studies in the region.”

According to Atossa Therapeutics:

AT-301 is Atossa’s proprietary formula intended for nasal administration in patients immediately following diagnosis of COVID-19 but who have not yet exhibited symptoms severe enough to require hospitalization. It is intended for at-home use to proactively reduce symptoms of COVID-19 and to slow the infection rate so that a person’s immune system can more effectively fight SARS-CoV-2 (coronavirus). Atossa also intends to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2.

The study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups. Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A. Part B is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives are to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation.

“Our AT-301 nasal spray program is being developed for COVID-19 patients who are not hospitalized, which complements our AT-H201 program being developed for COVID-19 patients on ventilators,” commented Steven Quay, M.D., Ph.D., President and CEO of Atossa. “Many COVID-19 patients are infected via the nasal passage, which makes a nasal spray therapy potentially very attractive. Collectively, the components of AT-301 are believed to replicate a ‘vaccine-like mechanism’ to help maintain a protective mucosal barrier within the nasal cavity with anti-viral properties that may lead to lower infectivity and reduced symptoms in COVID-19 patients due to their interference with the spike protein of the virus in the nasal cavity and upper respiratory tract. We may eventually develop AT-301 as a prophylaxis to reduce risk of being infected with COVID-19. For example, it could be taken as a daily vaccine-like treatment for people at higher-risk, such as TSA workers, emergency medical professionals and hospital personnel,” concluded Dr. Quay.

An application to commence the study has been submitted to the relevant institutional review board (IRB) and local regulatory authority in Australia which must be approved before commencement of the study. Pending these approvals, Atossa expects that the study will commence this quarter.

Adequate and well-controlled studies to demonstrate safety and efficacy must be successfully completed and regulatory approvals must be obtained before AT-301 may be commercialized. Atossa has filed provisional patent applications on AT-301 to treat patients diagnosed with, or to prevent, COVID-19 via nasal spray.

ABOUT ATOSSA THERAPEUTICS

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

See full announcement here https://atossatherapeutics.com/atossa-therapeutics-contracts-for-clinical-study-of-at-301-nasal-spray-atossas-second-covid-19-therapeutic-development-program/