Wednesday, April 28, 2021
ENGELWOOD — Ampio Pharmaceuticals (NYSE American: AMPE) has introduced optimistic ends in its AP-014 Phase I medical trial utilizing inhaled Ampion to deal with respiratory misery in sufferers resulting from COVID-19.
All sufferers within the research have now accomplished therapy, Ampio mentioned, together with a follow-up on day 28 after therapy.
Not solely did the research meet its main endpoint, in response to Ampio, however the remaining knowledge confirmed an excellent larger enchancment in all-cause mortality over sufferers handled with Standard of Care (SOC) than initially reported.
The mortality fee within the SOC group was 24%, whereas that within the group handled with SOC and Ampion was solely 5%, a 78% enchancment in all-cause mortality. Preliminary outcomes have been reported in March as 21% for SOC and eight% for Ampion, or an enchancment of 62%.
Other findings from the research proceed to point out a optimistic end result with Ampion therapy, together with:
• Patients receiving Ampion took much less time to be admitted to hospital. The imply hospital keep was 4 days shorter for the Ampion group in comparison with the sufferers who acquired SOC.
• Patients handled with Ampion have been both steady or confirmed enchancment on a scale of medical enchancment in comparison with sufferers handled with the SOC. At day 5, 89% of sufferers receiving Ampion have been steady or bettering in comparison with 77% of sufferers receiving SOC. This pattern of enchancment with Ampion therapy is seen as early as day 2 and continues via day 5.
• Treatment with Ampion was protected and nicely tolerated in all sufferers. There have been no notable uncomfortable side effects with Ampion therapy and no drug-related critical uncomfortable side effects have been reported.
“These are sturdy outcomes from a Phase I trial and we stay up for instantly continuing with the initiation of our double-blind, placebo-controlled Phase II trials utilizing Ampion in each an inhaled kind for COVID-19 respiratory misery and intravenous for extra systemic signs of COVID-19,” he mentioned Michael MacalusoPresident and CEO of Ampio.
“If these Phase II trials confirm the efficacy results of our Phase I trials, I envision that we can move forward quickly with an application for emergency use authorization for Ampion in the treatment of COVID-19.”
Ampio now has Investigational Review Board (IRB) approval for each Phase II trials and might start enrolling sufferers within the US. Conveyors.
In a separate press launch, Ampio introduced that it has acquired a optimistic response from the U.S. Food and Drug Administration for its plans for its Phase III trial utilizing intra-articular injection of Ampion for the therapy of osteoarthritis of the knee ( OAK).
The OAK research was paused in early 2020, together with greater than 1,000 different research, because of the COVID-19 pandemic, and the FDA issued steerage on steps to proceed with the research.
Ampio mentioned it’s going to present updates on its plans for this trial on its upcoming May 5 earnings name.