Ampio to end Covid program

Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunomodulatory therapies for the treatment of pain resulting from osteoarthritis in the knee and potentially other articular joints, today released the following letter to stockholders from its Chief Executive Officer, Mike Martino. ... How did we go from "positive results" for inhaled Ampion in the 40-patient AP-014 trial to "no signal" in these trials? In general, small exploratory studies may show a large treatment effect because of the small denominator and should always be viewed as hypothesis generating rather than definitive. Historically, across all drug development categories, only a minority of phase 2 trials can be confirmed in larger phase 3 trials. This is the reason why FDA requires two successful pivotal phase 3 trials. Specific to Ampion, the AP-019 trial enrolled 129 participants and could not show a beneficial effect of Ampion compared with placebo as only 3 deaths or progression to respiratory failure occurred (the original primary endpoint). The AP-017 trial which studied intravenous Ampion compared with placebo enrolled only 35 participants and had a very slow enrollment rate. We determined that the evolving treatment landscape combined with the reduced incidence and severity of COVID had significantly curtailed our ability to enroll the required 200 subjects and, as such, the trial was closed because of the projected time to completion and financial commitment. AP-018 was a small Phase 1 study to document safety that enrolled 32 patients and failed to show a benefit.

Given these results and the changing Covid treatment landscape, we believe it would be an unwise use of investor funds to continue the COVID-19 program at this time. As a reminder, AP-017 and AP-019 were initiated on the premise they might support an Emergency Medical Use Authorization (EMUA) in what was then a bleak landscape for Covid treatments. However, several treatments have recently been approved for the treatment of COVID-19, including antibodies that inactivate the SARS-cov-2 virus that causes Covid, as well as drugs that prevent viral replication, and corticosteroids that have demonstrated a reduction in the severity of the disease. Additionally, the prevalence of vaccines and multi-shot vaccination protocols and the diminishing severity of emerging variants of Covid-19, such as Omicron, have all converged to confer immunity and reduce the number of ICU patients requiring respiratory support. These developments make Covid prevention and treatment a very crowded competitive space in which Ampion simply hasn't demonstrated sufficient benefits to be competitive.

I would like to highlight the following positive takeaways which should not be minimized. We now know that nebulized (inhaled) Ampion has an excellent safety profile, which can potentially open up additional target indications that involve lung inflammation which are potentially more promising than COVID-19. Additionally, we have been issued four significant patents in the space. If, how or when we continue to pursue development of Ampion for treatment of respiratory inflammation has yet to be determined; although, I can say it is not a near term project or priority.

https://finance.yahoo.com/news/ampio-pharmaceuticals-ceo-mike-martino-203000147.html