Thursday October 29, 2020 0 comments
ENGLEWOOD -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) announced it has begun recruiting and enrolling patients in a Phase I multi-center, randomized, controlled trial for a total of 40 patients that will assess the safety and efficacy of inhaled Ampion added to the standard of care ("SOC") for COVID-19 infected patients hospitalized for respiratory distress.
Dosing of patients will begin at Penrose Hospital in Colorado Springs and will expand enrollment to other hospitals in the near future, Ampio said.
Michael Macaluso, Ampio's CEO, said specific features of the clinical trial include:
- Ampion will be administered to COVID-19 patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, as administered by either a hand-held nebulizer for COVID-19 patients with mild to moderate disease, or by non-invasive ventilation (face mask) and mechanical ventilation (intubation) in patients impacted with more severe disease.
- This US study will enroll 40 patients, randomized 1 to 1, Ampion in addition to SOC versus SOC alone. Each patient in the treatment arm will inhale 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.
- The first three patients inhaling Ampion will be assessed by a Safety Monitoring Committee for an additional three days after the 5-day treatment period, as required by the protocol, as inhalation is a new method of administration of Ampion approved for clinical use by the FDA. If no safety concerns arise, then open enrollment at the speed of recruitment will follow for the remaining patients.
"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,” said Macaluso.
“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 U.S. study. We will provide an update to our shareholders with more information as it develops."