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Atossa Therapeutics Announces Completion of 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
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"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, April 20, 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 has completed enrolling 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. 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 B of the study was successfully completed and, subject to approval from the ethics committee, we will now proceed to enroll the next group of participants,” said Steven Quay, M.D., Ph.D., Atossa’s CEO and President. “Despite widespread availability of vaccines, many areas of the world are seeing a recent surge in COVID-19 cases. There continues to be a strong need for additional therapies to combat COVID-19.”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 four 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. Parts A, B and C of the study are being conducted by Avance Clinical Pty Ltd., a leading Australian clinical research organization. Commencing Parts C and D of the study is subject to additional approvals from the Australian Human Research Ethics Committee.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 nebulizer to improve compromised lung function for moderately 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 c...