Atossa Therapeutics Receives Regulatory Approval To Open Clinical Study of AT-H201 in Australia

Rhea-AI Summary

Atossa Therapeutics (Nasdaq: ATOS) has received regulatory approval from the HREC to initiate a clinical study of its nebulized formulation AT-H201 in Australia. This therapy aims to assist both moderately to severely ill COVID-19 patients and long-haul patients suffering from post-infection pulmonary issues. The Phase 1/2a study will evaluate 60 participants and aims to determine the efficacy of AT-H201, which has shown promising potency in in vitro tests against SARS-CoV-2. Successful trial results and regulatory approvals are essential for commercialization.

Positive

• Received regulatory approval to conduct clinical study of AT-H201 in Australia.
• AT-H201 showed in vitro potency against SARS-CoV-2, being four times more potent than Remdesivir and twenty times more than Hydroxychloroquine.
• Development of a nebulized formulation allows for home treatment, expanding access for patients.

Negative

• Commercialization of AT-H201 depends on successful completion of clinical trials and obtaining regulatory approvals.
• No assurance of trial success or regulatory approvals, indicating investment risks.

Nebulized formulation being developed to improve lung function in both active-disease COVID-19 patients and “Long Haul” patients with post-infection pulmonary disease

SEATTLE, July 07, 2021 (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 in oncology and infectious diseases with a current focus on breast cancer and COVID-19, today announces it has received regulatory approval from HREC (Human Research Ethics Committee) to open a clinical study of AT-H201 in Australia. The nebulized formulation, AT-H201, is being developed as an inhalation therapy for moderately to severely-ill hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease.

“The COVID-19 pandemic continues to be an urgent health crisis with many regions reporting low vaccination rates combined with new SARS-CoV-2 variants proving more infectious and more deadly,” said Steven Quay, M.D., Ph.D., Atossa’s CEO and President. “If the initial parts of the study are successful we will study the efficacy of our proprietary AT-H201 on moderately ill COVID-19 patients who can be treated via a nebulizer. Our goal in developing nebulized AT-H201 is to improve lung function in patients with active disease, which may reduce the number of patients requiring ventilators and in “long-haul” patients who have residual pulmonary function damage. Up to one third of hospitalized patients have pulmonary function changes 60 days or more after recovering from COVID. The portability of nebulizers, already routinely used for other chronic lung disease, allows for treatment at home.”

The Phase 1/2a placebo-controlled study will enroll a total of 60 healthy participants and moderately-ill hospitalized COVID-19 patients. The study has 4 parts: a single ascending dose part, a multiple ascending dose part, a combination part in healthy individuals and a combination in COVID-19 infected patients and will be conducted with Avance Clinical Pty Ltd., a leading Australian clinical research organization.

AT-H201 is a proprietary combination of two drugs previously approved by the FDA to treat other diseases and by other administration routes. AT-H201 is intended to be inhaled via a nebulizer to improve compromised lung function for moderate to severely ill, hospitalized COVID-19 patients and for “long-haul” patients with post-infection pulmonary disease. In May 2020, we completed in vitro testing of AT-H201 which showed that the components of AT-H201 inhibit SARS-CoV-2 infectivity of VERO cells, which is a standard cell type being used to study infectivity of the coronavirus. The AT-H201 components were found to be at least four times more potent than Remdesivir and at least 20 times more potent than Hydroxychloroquine. Potency was measured by microscopic examination of the cytopathic effect caused by SARS-CoV-2 in VERO cells.

The Phase 1/2a study in Australia and other clinical studies must be successfully completed and regulatory approvals must be obtained before AT-H201 may be commercialized. No assurance can be given than studies will be successful or that regulatory approvals will be obtained.

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 in oncology and infectious diseases with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

Forward-Looking Statements Disclaimer Statement

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, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering, 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

FAQ

What is AT-H201 and how does it relate to COVID-19?

AT-H201 is a nebulized formulation being developed to improve lung function in COVID-19 patients, including those with long-haul symptoms.

When did Atossa Therapeutics receive approval for the clinical study of AT-H201?

Atossa Therapeutics received regulatory approval from the HREC to open a clinical study on July 7, 2021.

How many participants will be enrolled in the AT-H201 clinical study?

The Phase 1/2a clinical study will enroll a total of 60 healthy participants and moderately-ill hospitalized COVID-19 patients.

What are the next steps for Atossa after receiving regulatory approval?

Atossa will conduct the clinical study, which will assess the efficacy of AT-H201, and aims to achieve regulatory approvals for commercialization thereafter.

What were the in vitro results of AT-H201 against SARS-CoV-2?

In vitro testing showed that AT-H201 components were at least four times more potent than Remdesivir and twenty times more potent than Hydroxychloroquine.