Ampio Pharmaceuticals (NYSE: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today reported annual financial results for the year ended December 31, 2020 and provided a corporate overview / business update.
- Cash and cash equivalents totaled $17.3 million at December 31, 2020, compared to $6.5 million at December 31, 2019.
Mr. Michael Macaluso, President and CEO, noted, “The FDA has recently responded to our requests to expand our IV and Inhalation Covid-19 studies, utilizing Ampion, by recommending we conduct a randomized, double-blinded, placebo-controlled Phase II trial in each. They also indicated that their recommended trial design for both will allow for an effective and efficient review of data results, determine the safety and statistical significance and effectiveness of Ampion in comparison to Standard of Care, all of which are necessary for the FDA to objectively determine that the known and potential benefits of Ampion outweigh the known and potential risks and, consequently, Ampion may be considered for emergency use authorization (EUA).
In addition, we have provided a detailed proposal to the FDA in response to their recent guidance regarding the status of our Osteoarthritis of the Knee (OAK) Phase III clinical trial, which is paused as a result of the COVID pandemic. In summary, our response proposes analysis of the existing data in a reduced level of patients who had completed the 12-week study regimen for submission. It is important to note that this response is part of an ongoing active dialog with the FDA and until the FDA renders a final decision, this trial data will continue to remain paused and blinded to ensure clinical trial integrity.
Ampion is a platform biologic and, as such, is agnostic to whether it is treating a COVID patient or an osteoarthritis autoimmune condition. Simplified, Ampion directly and effectively addresses inflammation. Consequently, our ongoing and continued research and clinical trials may be applicable to a significant number of additional disease complications, not just COVID.”
About Ampio Pharmaceuticals Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio’s lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2035 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).