- All-cause mortality in patients treated using Standard of Care (SOC) was 24%, but only 5% in the group treated with Ampion (a 78% reduction)
- The AP-014 Phase I trial of inhaled Ampion in COVID-19 respiratory distress meets primary endpoint
- Phase II trials utilizing inhaled and intravenous Ampion ready to enroll patients
ENGLEWOOD, CO, April 27, 2021 – Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today revealed 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, including a follow-up at Day 28 after treatment.
The study not only met its primary endpoint, 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,” commented Michael Macaluso, President and CEO of Ampio. “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 today announced that it had received a positive response from the U.S. Food and Drug Administration (FDA) 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 will provide updates on its plans for this trial at its upcoming May 5th earnings call.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies 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 (BPCIA).
Forward Looking Statements
Ampio’s statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include statements regarding Ampio’s expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including without limitation, under Ampio’s Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.