acetylcysteine/enoxaparin (AT-H201) / Atossa Therap - LARVOL DELTA

Atossa Therapeutics Receives Regulatory Approval To Open Clinical Study of AT-H201 in Australia (GlobeNewswire) - "Atossa Therapeutics, Inc....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 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..."

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Atossa Therapeutics President and CEO Dr. Steven C. Quay Issues Annual Letter to Stockholders Highlighting Key Accomplishments and Strategy for 2021 (GlobeNewswire) - "AT-301 Nasal Spray for the Treatment of COVID-19: During 2020, we completed successful in-vitro testing followed by a Phase 1 clinical study...We expect to release final data from this study in the first quarter of 2021 and then quickly start additional pre-clinical and clinical studies...AT-H201 Inhalation Therapy for COVID-19...We have applied to the regulatory authorities to conduct the initial clinical study of AT-H201 in Australia, which we anticipate receiving in first quarter 2021."

New trial • P1 data • Infectious Disease • Novel Coronavirus Disease

Atossa Therapeutics Contracts with NYC Health + Hospitals/Metropolitan for COVID-19 HOPE Clinical Study (GlobeNewswire, Atossa Therapeutics, Inc.) - "Atossa Therapeutics, Inc....today announced that it has contracted with NYC Health + Hospitals/Metropolitan in New York City to conduct the NY HOPE Study of Atossa’s proprietary combination drug therapy called AT-H201....Thirty-nine patients will be enrolled in the active treatment group and compared to the outcomes of 66 patients in a matched retrospective control group. Patients will be dosed with AT-H201 each day in addition to the standard of care, while on mechanical ventilation for up to seven days and will be followed up during hospitalization and for 28 days after discharge....The NY HOPE Study is currently pending IRB approval and will not commence without IRB and all necessary regulatory approvals, including FDA. Atossa has filed comprehensive provisional patent applications related to AT-H201."

Trial status • Infectious Disease • Novel Coronavirus Disease

Atossa Therapeutics Seeks Clinical Investigation Approval from FDA to Launch the COVID-19 HOPE Study (GlobeNewswire, Atossa Therapeutics, Inc.) - "Atossa Therapeutics, Inc....has applied to the FDA for approval to commence a clinical study of its proprietary drug, AT-H201, in COVID-19 patients on mechanical ventilation....The goal of the clinical trial, called the HOPE Study, is to demonstrate improved lung function and reduce the amount of time that COVID-19 patients are on ventilators....'This is the first trial that I am aware of that is testing nebulized pharmaceuticals for patients on mechanical ventilation. Atossa looks forward to working on this important medical need and to reduce the death toll of COVID-19.'"

FDA event • New trial • Infectious Disease • Novel Coronavirus Disease