Ampio Pharmaceuticals has announced the initiation of a Phase 1 trial of an inhaled formulation of its Ampion anti-inflammatory biologic; the company had announced plans for the trial in September 2020 after having said in March 2020 that it intended to develop nebulized Ampion for the treatment of respiratory distress due to COVID-19.
The trial is expected to enroll 40 COVID-19 patients hospitalized with respiratory distress who will either receive Ampion 4 times per day for 5 days plus standard of care or standard of care alone. Patients with mild to moderate respiratory distress will receive Ampion via a hand-held nebulizer; patients with severe respiratory distress will receive Ampion via face mask and mechanical ventilation.
Ampio CEO Michael Macaluso commented, “The FDA has now granted two separate INDs and protocols of administration of Ampion for the treatment for COVID-19 patients, inhalation and intravenous, and a third method of administration, by direct intra-articular injection into the knee for patients suffering from severe osteoarthritis-of-the-knee. These various indications and modes of administration of Ampion strengthens the company’s belief that Ampion is a platform drug, which is potentially useful for a number of additional inflammatory conditions. We are currently investigating the possibility of conducting a series of similar inhalation studies world-wide that would run concurrently with the US study. We will provide an update to our shareholders with more information as it develops.”
Read the Ampio Pharmaceuticals press release.
