Atossa Therapeutics Announces Positive Interim Safety Assessment of First Group of Participants in Clinical Study of AT-301 Nasal Spray Being Developed for COVID-19

Rhea-AI Summary

Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported a positive interim safety assessment from the first cohort of its Phase 1 clinical study for AT-301, a nasal spray drug candidate aimed at treating COVID-19. The study involved 8 healthy participants who received either a placebo or an active dose, leading to a favorable safety review. This milestone allows the company to proceed with patient enrollment for higher doses and repeated dose cohorts. The Phase 1 study, taking place in Australia, focuses on the safety and tolerability of AT-301, thus paving the way for further efficacy investigations.

Positive

• Positive interim safety assessment allows continuation to the next cohort.
• Study successfully completed first cohort with no adverse effects reported.
• Progression to higher doses and repeated dose cohorts anticipated, increasing potential for efficacy results.

Negative

• None.

SEATTLE, Sept. 01, 2020 (GLOBE NEWSWIRE) -- 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 a positive interim safety assessment from the first cohort of healthy participants in the Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. This first group of 8 participants received a single dose of either AT-301A (placebo) or AT-301B (active drug). This blinded, positive assessment by the safety committee allows the study to now enroll the next cohort.

“This favorable safety review is an important milestone,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO. “First in human studies typically have an early safety assessment to ensure the drug is not harming participants and this positive assessment allows us to continue enrolling patients, including at higher doses and in repeated dose cohorts. We look forward to completing this Phase 1 safety and tolerance study so that we can begin to investigate the safety and efficacy of AT-301 in preventing and/or mitigating a COVID-19 infection.”

The 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.

Forward-Looking Statements

Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between interim and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies of AT-H201, AT-301 and Endoxifen, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, whether reduction in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

Company Contact:
Atossa Therapeutics, Inc.
Kyle Guse, CFO and General Counsel
Office: 866 893-4927
kyle.guse@atossainc.com

Investor Relations Contact:
Core IR
Office:(516) 222-2560
ir@atossainc.com

Source: Atossa Therapeutics, Inc.

FAQ

What is the latest news about Atossa Therapeutics (ATOS) related to its COVID-19 drug?

Atossa Therapeutics announced a positive interim safety assessment from the first cohort in its Phase 1 clinical study of AT-301, allowing further patient enrollment.

What are the next steps for the Phase 1 study of AT-301?

Following the positive safety assessment, Atossa will proceed to enroll additional cohorts at higher doses and begin multiple dose studies.

What is the primary objective of Atossa's Phase 1 study on AT-301?

The primary objective is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal spray in healthy volunteers.

How many participants are involved in the Phase 1 study of AT-301?

The Phase 1 study includes 32 healthy adult subjects divided into two study groups.