Benzinga | Jan 18, 2022 09:32AM EST

Atossa Therapeutics Announces Advancement To Part B Of Clinical Study Of AT-H201

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, Jan. 18, 2022 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical stage biopharmaceutical company seeking to 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 is advancing to enroll participants in Part B of its Phase 1/2a clinical study of AT-H201 in Australia, consisting of multiple ascending dose cohorts in healthy participants. 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.

Part A of the study, which consisted of a single ascending dose group of 4 cohorts of healthy participants, has now been completed. The Australian Human Research Ethics Committee has reviewed the safety data from Part A and has approved the study to proceed to Part B.

"The results of the first part of the study were extremely encouraging and the ethics committee concluded we may now proceed to enroll the next group of participants," said Steven Quay, M.D., Ph.D., Atossa's CEO and President. "A record number of hospitalizations driven by the Omicron variant is producing a crisis at many healthcare facilities. Additional therapies to combat COVID-19 are desperately needed."

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: Part A - a single ascending dose part, Part B - a multiple ascending dose part, Part C - a combination part in healthy individuals, and Part D a combination in COVID-19 infected patients. The study is being conducted by 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 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.