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

August 27, 2020

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 in the Phase 1 clinical study using its proprietary drug candidate AT-301, being administered by nasal spray.

Adelaide, Australia – 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/

About Avance Clinical
Australia’s Avance Clinical has more than 20-years of experience and is now one of Australia’s leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.
Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team.
The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.
Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Visit http://www.avancecro.com for more information.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia’s counter-flu and allergy seasons

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