Benzinga | Nov 17, 2020 09:16AM EST

Amipo Pharma Reports Third Group In Phase 1 Inhaled Ampion Study Being Treated Following Clearance By Safety Monitoring Committee

Ampio Pharmaceuticals, Inc. (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today that the third group in the Phase I inhaled Ampion(tm) clinical study is being treated following clearance by the Safety Monitoring Committee (SMC) who found Ampion to be safe and well-tolerated after reviewing the results from the first and second treatment groups.



Michael Macaluso, Ampio's, President and CEO, clarified specific features of this clinical trial:

* "Ampion is being administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, using a hand-held nebulizer for COVID-19 patients early in the disease and non-invasive ventilation (face mask) and mechanical ventilation (intubation) if their disease state is more severe.

* This US based study will enroll 40 patients, randomized 1 to 1, inhaled Ampion versus Standard of Care (SOC), with each patient inhaling 8 ml doses of Ampion four (4) times a day for five (5) days. Safety is the primary end point and various measurements indicative of efficacy are secondary endpoints.

* Each of the first three patient groups receiving inhaled Ampion are assessed by the SMC for an additional three days after the 5 day treatment period (as inhalation is a new method of administration of Ampion cleared for clinical use by the FDA) and if no safety concerns arise for this third group, the trial will accelerate to complete enrollment of the remaining 34 patients at the speed of recruitment."

Mr. Macaluso further noted, "The FDA has now cleared two types of administration of Ampion (i.e., inhalation and intravenous) for treatment of COVID-19 patients. In addition, a third method of administration, direct injection into the knee for patients suffering from severe osteoarthritis of the knee, supports the Company's belief that Ampion is a platform drug, potentially useful for a number of inflammatory diseases throughout the body. We are continuing our investigation of conducting a similar inhalation study overseas that we expect will run in close proximity with the US study. We will provide an update with more information as it develops."