Ampio Pharmaceutical Inc. (NYSEAMERICAN:AMPE) has announced that the third group in its Phase 1 inhaled Ampion™ clinical trial is receiving treatment after clearance by the Safety Monitoring Committee (SMC). The SMC established that Ampion was safe and well-tolerated following a review of the first and second treatment group results.
Ampio to enroll 40 patients in Ampion study
The company’s CEO and President, Michael Macaluso, clarified certain features of the clinical study. He said that they administer Ampion to patients through inhalation, which allows the drug to target directly and attenuate lung inflammation. The company employs a hand-held nebulizer for early-stage COVID-19 patients and mechanical ventilation (intubation) and non-invasive ventilation (face mask) if the patients have severe COVID-19.
Macaluso said that the US-based trial plans to enroll 40 participants randomized 1:1 for inhaled Ampion against Standard of Care (SOC). Each patient will inhale 8 ml Ampion doses four times per day for five days. According to Macaluso, the study’s primary endpoint will be safety, and secondary endpoints will be various measurements showing efficacy. SMC will assess the first three patients that will receive Ampion for another three days after the treatment period. If there will be no safety concerns for the third group, the study will accelerate to finalize enrolment for the rest of the patients.
Ampion has the potential of treating various inflammatory diseases
The FDA has already cleared two Ampion administration types (i.e., intravenous and inhalation) for COVID-19 patient treatment. Ampion inhalation is a new administration method recently cleared by the FDA for clinical use. Macaluso also noted that a third administration method through injection to the knee for patients with severe osteoarthritis of the knee confirms Ampio’s belief that the Ampion drug platform can potentially offer meaningful benefit for various inflammatory diseases.
He added that the company would continue its studies by conducting a similar inhalation trial overseas, expected to run in proximity with the US trial. Macaluso concluded that the company would offer additional information on the progress of the study as it develops.