Wednesday April 28, 2021 0 comments
ENGLEWOOD -- Ampio Pharmaceuticals (NYSE American: AMPE) announced positive results in its AP-014 Phase I clinical trial utilizing inhaled Ampion in treating respiratory distress in patients as a result of COVID-19.
All patients in the study have now completed treatment, Ampio said, including a follow-up at Day 28 after treatment.
The study not only met its primary endpoint, according to Ampio, but the final data showed an even greater improvement in all-cause mortality over patients treated using Standard of Care (SOC) than initially reported.
Mortality in the SOC group was 24%, while that in the group treated with SOC and Ampion was only 5%, a 78% improvement in all-cause mortality. Preliminary results had been reported in March as 21% for SOC and 8% for Ampion, or a 62% improvement.
Other findings from the study continue to show a positive outcome with Ampion treatment, including:
• Patients who received Ampion required less hospitalization time. The average hospital length of stay was 4 days less for the Ampion group compared to the patients receiving SOC.
• Patients treated with Ampion were either stable or showed improvement on a scale of clinical improvement compared to patients treated using SOC. By day 5, 89% of patients who received Ampion were stable or had improvement compared to 77% of patients who received SOC. This trend in improvement with Ampion treatment is noted as early as day 2 and continues to day 5.
• Ampion treatment was safe and well-tolerated in all patients. There were no remarkable adverse events with Ampion treatment, and no drug-related serious adverse events were reported.
"These are strong results from a Phase I trial, and we are looking forward to continuing immediately with the commencement of our double-blind placebo-controlled Phase II trials utilizing Ampion in both in an inhaled form for COVID-19 respiratory distress and intravenously for more systemic symptoms of COVID-19," said Michael Macaluso, Ampio president and CEO.
"If these Phase II studies confirm the efficacy results seen in our Phase I trials, I can envision moving forward quickly with an application for Emergency Use Authorization for Ampion in treating COVID-19."
Ampio now has Investigational Review Board (IRB) approvals for both Phase II trials and is able to begin enrolling patients in the U.S. The company is awaiting IRB approval for its Phase I study in using Ampion to address the respiratory symptoms experienced by COVID-19 Long Haulers.
In a separate release, Ampio announced it received a positive response from the U.S. Food and Drug Administration on its plans for its Phase III trial utilizing intra-articular injection of Ampion for treating osteoarthritis of the knee (OAK).
The OAK trial was paused in early 2020, along with over 1,000 other trials, because of the COVID-19 pandemic, and the FDA was providing guidance on steps for moving forward with the trial.
Ampio said it will provide updates on its plans for this trial at its upcoming May 5 earnings call.