ENGLEWOOD, Colo., March 2, 2022 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on advancing immunomodulatory therapies for common inflammatory conditions, today announced positive data from the intent-to-treat population (mITT) in the company’s AP-013 study, a Phase 3 clinical trial of the company’s lead candidate, Ampion™, in patients with severe osteoarthritis of the knee (OAK).
The AP-013 study was designed to confirm the efficacy observed in the first pivotal trial, AP-003-A, and was designed to detect treatment differences between Ampion and the saline control. The trial required more patients to assess improvements in function than to assess improvements in pain alone. The AP-013 study was initiated in June 2019 and was ongoing when the COVID-19 outbreak occurred, which resulted in a large amount of missing data due to the pandemic.
“Due to large amounts of missing data, our analyzes of the AP-013 data began by applying the FDA’s recommendation to conduct a sensitivity analysis to determine if there was an impact of COVID-19 on the study, which we described and documented in a study design before unblinding the data,” said Holly Cherevka, President and Chief Operating Officer of Ampio. “This sensitivity analysis revealed a statistically significant impact of COVID-19, and as specified in our study design, we proposed a mITT population to assess efficacy. In this mITT population (n=618), which retained over 85% power to assess improvements in pain, Ampion demonstrated a statistically significant reduction in pain (p=0.042) and a favorable trend for improved function compared to saline control. results in the per-protocol efficacy population (n=580), included in the original PA-013 statistical analysis plan, support these observations with a statistically significant reduction in pain (p=0.020) and a statistically significant improvement in function (p=0.027) compared to saline control.”
Michael MartinoCEO of Ampio, added, “We believe the AP-013 data supports the AP-003-A results and confirms the safety and efficacy of Ampion for the treatment of pain caused by severe OAK. Earlier this year, we submitted a Type C Meeting Request to the FDA. The FDA has acknowledged receipt of our request and confirmed that it will provide written responses to our questions in the next step. To support our position and inform the FDA’s response, we recently submitted a detailed information package. I believe we are on track to deliver clarity on AP-013 by the end of the first half of this year, as previously reported.”
Ampio’s leadership team will host a live webinar to discuss the latest data insights and answer questions.
Date hour : March 2, 2022, 4:30 p.m. EST
Canada call number (toll-free): 1 833 950 0062
Canada call number (local): 1 226 828 7575
United States (Free): 1 833 927 1758
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Access code: 644727
*Participants must enter the participant access code before being greeted by an operator
In order to submit questions, participants must have an internet connection, as questions will only be answered via the webcast. The conference call line will be in listen-only mode.
The webinar can also be accessed from the Investor Relations section of the Company’s website at www.ampiopharma.com and will be archived there shortly after the live event.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on advancing immunology-based therapies to treat prevalent inflammatory conditions for which treatment options are limited. Ampio’s lead drug, Ampion™, is backed by an extensive patent portfolio with intellectual property protection extending to 2037 and may be eligible for 12-year market exclusivity from the FDA after approval as a as a new organic product under the Organic Pricing Competition and Innovation Act (BPCIA).
Statements by Ampio in this press release and webinar that are not historical facts, 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 regarding Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, clinical trials and decisions, and changes in business conditions and similar events and the likelihood and the timing of Ampion’s approval as a new biologic under the BPCIA, 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, 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.
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SOURCEAmpio Pharmaceuticals, Inc.