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

November 3, 2020

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.

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.

About Avance Clinical 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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