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Avance Clinical Client News: XWPharma Initiates First-in-Human Studies of XW10508, in Development for Fast-acting Relief of Treatment-Resistant Depression and Chronic Pain

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Avance Clinical, the largest premium Australian CRO for international biotechs, is pleased to share the news that its client XWPharma Ltd. has announced dosing of subjects in its first-in-human study evaluating XW10508, the Company’s novel, patented, glutamatergic NMDA antagonist and AMPA activator in development as an oral, once-daily therapy for the treatment of treatment-resistant depression and chronic pain.

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Avance Clinical Congratulates Client Tetherex Pharmaceuticals on Initiation of Dosing in a Phase 1 Clinical Study Using a Novel Single-Cycle Adenovirus Vaccine Strategy in Australia

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The largest Australian full-service CRO for international biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical today congratulated client Tetherex Pharmaceuticals on first patient dosing for its Phase 1 vaccine clinical trial.

Tetherex Pharmaceuticals, Inc. is a privately held, clinical stage biopharmaceutical company focused on development of selectin inhibitor therapeutics for the treatment of a broad range of inflammatory diseases and single-cycle adenovirus vaccines for multiple infectious diseases and cancer indications.

Avance Clinical Chief Scientific Officer Dr Gabriel Kremmidiotis said:

“The exciting aspect of the Tetherex product is the potential to vaccinate using a nasal spray. Administering the vaccine via the same route that the virus uses to get into our bodies, may result in more effective protection compared to the first generation Covid-19 vaccine products currently being administered as injectables. Commencement of dosing with the Tetherex Covid-19 vaccine product constitutes a major achievement for the Avance Clinical team who played a key role in supporting Tetherex in gaining regulatory approval to conduct the First-in-Human trial with their exciting vaccine candidate.”

According to Tetherex Pharmaceutical’s announcement:

Tetherex Pharmaceuticals has executed an exclusive worldwide license with Mayo Clinic for the development and commercialization of a novel single-cycle adenovirus vaccine platform. The platform will be used to target multiple infectious diseases, beginning with a Phase 1 clinical study investigating a vaccine for COVID-19. Dosing of the initial cohort of the Phase 1 study is underway in Australia.

“Current adenovirus vaccines under investigation for COVID-19 and other infectious diseases are highly restricted in the amount of vaccine antigen they can deliver to cells,” said Dr. Russell Rother, President and Chief Operating Officer of Tetherex. “The single-cycle adenovirus platform allows one round of robust vaccine antigen expression to occur without the generation of infectious virus particles which, in preclinical models, translates to a marked improvement in the ensuing immune response.”

About the Single Cycle Adenovirus Vaccine Platform

The single-cycle adenovirus platform was developed to enhance the expression of target antigens, amplifying immune responses to infectious disease targets. Preclinical studies have demonstrated that the single-cycle adenovirus can increase target antigen expression up to 100-fold over currently utilized replication defective adenovirus vaccines. Intranasal administration of single-cycle vaccine elicits both systemic and mucosal immune responses. A mucosal response allows the immune system to encounter respiratory viruses like SARS-CoV-2 at the site of entry while the viral titers are lower. The platform also provides a robust manufacturing and supply chain paradigm relative to other vaccine platforms, such as mRNA.

Tetherex’s Phase 1 open label study, designed to assess safety, reactogenicity and immunogenicity of the single-cycle adenovirus vaccine, is expected to recruit a total of approximately 80 healthy volunteers and includes both a single ascending dose group and a multiple dose group. Subjects will receive the vaccine via either intramuscular or intranasal administration.

The study site is Nucleus Network in Brisbane, and Dr Paul Griffin Nucleus Network’s Principal Investigator said:

“The covid 19 global pandemic continues to impact lives around the world. We are very fortunate to have developed a number of vaccines for Covid-19 already that are safe and highly effective. These vaccines are beginning to give us the capacity to start to reduce the impact of this viral infection, however it’s clear there are certain properties of these vaccines that we would ideally like to improve upon such as having a vaccine that could be given via a route other than needle and syringe and perhaps a vaccine that could further reduce the ability for a vaccinated individual to become infected in the first place, a so called transmission blocking vaccine. A vaccine given intranasally has the potential to achieve some of these objects hence I am very excited to be the principal Investigator on the Tetherex clinical trial.”

“The addition of this novel vaccine platform to the Tetherex portfolio significantly expands our ability to leverage our scientific and clinical development expertise and broadens our overall technology base. This reduces risk to our investors while providing the potential of significant upside,” said Dr. Scott Rollins, Chairman and Chief Executive Officer of Tetherex. “The platform will be utilized to target multiple infectious diseases which allows Tetherex to seek partnerships and alliances for the ever-expanding infectious disease marketplace.”

Avance Clinical Client XWPharma Announces Positive Results from Phase 1 Clinical Trials of XW10172, in Development as Once-Nightly Therapy for Sleep Disorders in Patients with Neurodegenerative Diseases

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The leading Australian CRO for international biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical today congratulated client XWPharma on receiving positive results from its Phase 1 clinical trial of XW10172.

XWPharma is a biopharmaceutical company dedicated to the discovery and development of novel therapeutics, utilizing its proprietary platform chemistry. XWPharma’s expertise in drug design is focused on providing potential first- and best-in-class medicines with differentiated features to address the unmet medical needs of patients suffering from debilitating neurological diseases.

Avance Clinical Chief Scientific Officer Dr Gabriel Kremmidiotis said:

“We are very pleased with the positive results announced by XWBiolabs on their product XW10172. Our team has been responsible for the trial management, monitoring, biometrics and medical writing elements of this trial. These results provide further validation of Avance’s strong reputation and deep expertise in executing early phase clinical trials which include pharmacokinetic endpoints as part of the trial’s main objectives.”

According to XWPharma:

XWPharma Ltd. today announced that XW10172, an internally discovered, novel, patented conjugate of the GABAB agonist oxybate, demonstrated in Phase 1 clinical trials multiple features that support development for treatment for various sleep disorders. The results of these studies were presented by Daniel Canafax, PharmD, Chief Medical Officer of the company, in a podium presentation at virtual SLEEP 2021, the annual meeting of the Associated Professional Sleep Societies.

“We are excited to have this opportunity at the SLEEP 2021 meeting to share promising clinical data from our lead drug candidate, XW10172,” said Leonard Blum, XWPharma’s President and CEO. “We are extremely encouraged by these Phase 1 results, which support XW10172 as an innovative treatment to address the debilitating symptoms and underlying fragmented sleep architecture seen in patients with sleep disorders that are common across many CNS disease states. In addition, we believe these results reflect the strength of our expertise in novel chemistry, neurobiology, and development that enable the creation of drugs that are uniquely fit for purpose and will make a difference in patients’ lives.”

“For patients with a variety of sleep disorders, these results establish desired drug properties, including a favorable safety profile and optimal pharmacokinetics suitable for once-nightly dosing of XW10172,” said Dr. Canafax. “Based on these data, we believe the drug offers potential as treatment in sleep disorders in patients with Parkinson’s disease and patients with other neurodegenerative diseases, for which no drugs are currently indicated despite the high unmet medical need. Additionally, once-nightly dosing and the absence of sodium are features that support XW10172 as potential best-in-class treatment for patients with narcolepsy.”

In healthy volunteers an immediate-release oral formulation of XW10172 was rapidly absorbed and metabolized to release oxybate at concentrations that matched equal molar doses of sodium oxybate, currently approved for treatment of narcolepsy. In addition, XW10172 was generally well-tolerated and adverse events seen are known effects of oxybate. Reports of somnolence, which is the desired pharmacological effect of XW10172, showed a concentration-effect relationship.

In a crossover study in healthy subjects that evaluated multiple time-based modified-release formulations of XW10172, each of these formulations delivered oxybate at concentrations considered to be effective at promoting sleep, increasing slow wave sleep, and consolidating sleep stages that are associated with improved sleep quality and reductions in excessive daytime sleepiness and cataplexy. The modified-release formulations maintained those desired concentrations over 6-7 hours following oral ingestion. Concentrations quickly declined below target levels 7-8 hours after dosing, the desired waking time.

These data support progression of XW10172 for further clinical evaluation. The Company plans to initiate a Phase 2 study in the coming months in patients with Parkinson’s disease suffering from sleep disorders, followed by a single Phase 3 pivotal study in narcolepsy patients.

The abstract and poster presentation of these data can be found on the SLEEP 2021 website at https://www.sleepmeeting.org/.

About XWPharma www.xwpharma.com

XWPharma is a biopharmaceutical company dedicated to the discovery and development of novel therapeutics, utilizing its proprietary platform chemistry. XWPharma’s expertise in drug design is focused on providing potential first- and best-in-class medicines with differentiated features to address the unmet medical needs of patients suffering from debilitating neurological diseases.

See the full announcement here https://www.globenewswire.com/news-release/2021/06/14/2246472/0/en/XWPharma-Announces-Positive-Results-from-Phase-1-Clinical-Trials-of-XW10172-in-Development-as-Once-Nightly-Therapy-for-Sleep-Disorders-in-Patients-with-Neurodegenerative-Diseases.html

About Avance Clinical
Avance Clinical is the largest full-service Australian CRO delivering quality clinical trials in Australia and New Zealand for international biotechs.

Avance Clinical has been delivering CRO services in the region for the past 24 years.

The company’s clients are international biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Avance Clinical delivers customised solutions designed around specific client needs rather than a one size fits all approach.

As a company Avance Clinical has focussed on state-of-the-art technology and systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, and Medrio are just some of our technology partners.

The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of candidates who demonstrate passion and expertise in their chosen field.

Visit https://www.avancecro.com for more information.

Recent Awards:

Excellence in Business Award 2021

Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020

Avance Clinical Client Atossa Therapeutics Announces Final Results from Phase 1 Clinical Study Showing Safety and Tolerability of AT-301 Nasal Spray Being Developed for COVID-19

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The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical congratulated Atossa Therapeutics on the announcement of their Phase 1 final results for the AT-301 nasal spray being developed for COVID-19.

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 Lungershausen, CEO, Avance Clinical said:

“As the CRO for this important study, we congratulate Atossa Therapeutics on these impressive safety and tolerability clinical results. Atossa Therapeutics have tapped the full scope of our CRO services including ClinicReady, our scientific and medical affairs specialist team. Australian clinical trials are recognized globally for their speed and accuracy and the fact that the clinical data is accepted by all major regulatory authorities including the FDA. Increasingly our clients are also tapping the generous 43.5% Australian Government rebate to support their clinical research.”

According to Atossa Therapeutics:

Atossa Therapeutics today announced final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered to be safe and well-tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19. There are currently no FDA-approved therapies to treat COVID-19 at home.

Final analysis of the data from the study indicates that there were no serious adverse events, no discontinuations, no bronchospasms, and only one subject of the 32 subjects in the study experienced adverse events that were considered moderate in severity and all other adverse events were considered mild.

Atossa’s assessment is that AT-301 nasal spray was safe and well-tolerated in this study. The most common treatment-related adverse events observed with AT-301 treatment with either single or multiple doses were nasal discomfort and sneezing.

“The results from this study are very encouraging and we look forward to quickly commencing the next study of AT-301,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO.

Atossa believes that AT-301 nasal spray will play an important role alongside the traditional vaccines now being deployed, particularly as it becomes clear that it will take months or years for vaccines to be administered around the world.

The Phase 1 study was a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects who were 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 was a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two different doses.

The primary objectives of the study were to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives were to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation.

The study was being conducted in Australia

See full announcement here

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.

 

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

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

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

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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/