News: Avance Clinical Client Atossa Therapeutics Announces Second Positive Interim Safety Assessment in Clinical Study of AT-301 Nasal Spray Being Developed for the Coronavirus Causing COVID

October 8, 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 client Atossa Therapeutics has announced a positive interim safety assessment from the second cohort of healthy participants in the Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301 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 client Atossa Therapeutics has announced a positive interim safety assessment from the second cohort of healthy participants in the Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301 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, announced a positive interim safety assessment from the second cohort of healthy participants in the Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray.

This second group of eight participants received a single escalated dose of either AT-301A (placebo) or AT-301B (active drug). The blinded, positive assessment by the safety committee allows the study to now enroll the next cohort, which will be the third of a total of four cohorts and the first of two multi-dose, placebo controlled cohorts.

“This second favorable safety review marks an important milestone in this study as half the participants have now been dosed and initial safety reviews have been successfully completed,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO. “Based on rapid enrollment in the first half of the study, we expect to complete enrollment in the remainder of the study very quickly. Recent data from the CDC suggests that more than 90% of people testing positive for COVID-19 do not require hospitalization. With this in mind, we are developing our AT-301 nasal spray for home-use because there are no currently FDA-approved treatments to help these patients with early disease to recover faster.”

Significant advances have been made in the field of COVID-19 diagnostic testing. These tests are now much more widely available and they can render results much more quickly. Atossa plans to identify potential partners who are developing these 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 communities and those working in higher-risk areas, including healthcare workers, emergency responders and teachers.

“We anticipate that our AT-301 nasal spray will complement any traditional COVID-19 vaccine that may be developed,” added Dr. Quay. “A traditional COVID-19 vaccine may be effective in in as few as half of the people taking it and recent surveys indicate that as many as one-third of Americans may choose not to take any COVID-19 vaccine once one becomes available. In addition, studies of re-infection with the coronavirus suggest that the durability of immunity, whether from an actual infection or a vaccine, may not be ideal. As a result, therapies such as our nasal spray, similar to therapies working in tandem with vaccines for seasonal flu, may form an important part of a broader response to the coronavirus pandemic.”

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.

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.’

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: https://atossatherapeutics.com/atossa-therapeutics-receives-second-positive-interim-safety-assessment-in-clinical-study-of-at-301-nasal-spray-being-developed-for-the-coronavirus-causing-covid/

About Avance Clinical http://www.avancecro.com
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.
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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media@avancecro.com

Chris Thompson

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