Ampio Pharmaceuticals, Inc. Releases Positive Phase 3 Data Analysis for Ampion™ Targeting Severe Osteoarthritis of the Knee (OAK)

Rhea-AI Summary

Ampio Pharmaceuticals, Inc. (AMPE) announced promising results from its Phase 3 AP-013 study of Ampion™ for treating severe osteoarthritis of the knee. The study showed a statistically significant pain reduction (p=0.042) in the modified Intent-to-Treat population (n=618) and notable improvements in function (p=0.027) compared to saline control. These results corroborate findings from the earlier AP-003-A trial. The company has engaged with the FDA regarding next steps, anticipating further clarity on the data by mid-2022.

Positive

• Demonstrated statistically significant pain reduction (p=0.042) in AP-013 study.
• Significant improvement in function (p=0.027) compared to saline control.
• Data supports efficacy observed in previous AP-003-A trial.
• Engaged with FDA on next steps, showing proactive regulatory strategy.

Negative

• COVID-19 impacted data quality, resulting in large amounts of missing data.
• Study required a larger patient population due to pandemic-related challenges.

ENGLEWOOD, Colo., March 2, 2022 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunomodulatory therapies for common inflammatory conditions, today announced positive data from the modified Intent-to-Treat (mITT) population in the Company's AP-013 study, a Phase 3 clinical trial of the company's lead candidate, Ampion™, in patients suffering from 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 powered to detect treatment differences between Ampion and saline control. The trial required a larger number of patients to evaluate improvements in function, than it required to evaluate 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.

"As a result of the large amounts of missing data, our analyses of the AP-013 data started with applying FDA's recommendation to conduct a sensitivity analysis to determine if there was an impact of COVID-19 on the study, which we outlined and documented in a study plan prior to unblinding the data," said Holli Cherevka, Ampio's President and Chief Operating Officer. "This sensitivity analysis found a statistically significant impact from COVID-19, and as specified in our study plan, we have proposed a mITT population to assess efficacy. In this mITT population (n = 618), which retained more than 85% power to evaluate improvements in pain, Ampion demonstrated a statistically significant reduction in pain (p=0.042) and trended favorably toward improvement in function versus saline control. Further, the results in the Per Protocol efficacy population (n = 580), included in the original AP-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) versus saline control."

Mike Martino, Ampio's Chief Executive Officer and Chairman added, "We believe that the AP-013 data confirms the results from AP-003-A and supports the safety and efficacy of Ampion for the treatment of pain from severe OAK. Earlier this year we submitted a Type C meeting request to FDA. FDA acknowledged our request and confirmed they will provide written responses to our questions as the next step. To support our position and inform FDA's response, we recently submitted a detailed briefing package. I believe we are on track to provide clarity on AP-013 by the end of the first half of this year, as previously guided."

Webinar Details

Ampio's executive team will host a live webinar to discuss the latest data analyses and respond to questions.

Date/Time: March 2, 2022, at 4:30 pm EST 
Webinar link:  https://event.on24.com/wcc/r/3574331/964B6C5B80DB9EFD05CA55D0977BD0D5 
Canada dial-in number (Toll Free): 1 833 950 0062 
Canada dial-in number (Local): 1 226 828 7575 
United States (Toll Free): 1 833 927 1758 
United States (Local): 1 646 904 5544 
All other locations: +1 929 526 1599 
Access code: 644727

*Participants will need to enter the participant access code before being met by an operator

In order to submit questions, participants must have Internet connectivity, as questions will only be addressed 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 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 2037 and may 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 and webinar 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, clinical trials and decisions and changes in business conditions and similar events and the likelihood and timing of Ampion's approval as a novel 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, 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.  

Investor and Media Contacts: 
Tony Russo or Nic Johnson 
Russo Partners 
info@ampiopharma.com 
tony.russo@russopartnersllc.com 
nic.johnson@russopartnersllc.com 

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SOURCE Ampio Pharmaceuticals, Inc.

FAQ

What were the results of the AP-013 study from Ampio Pharmaceuticals?

The AP-013 study showed a statistically significant pain reduction (p=0.042) and improvement in function (p=0.027) for Ampion compared to saline control.

What is the significance of the Phase 3 study for Ampion?

The Phase 3 study aims to confirm the efficacy of Ampion in treating severe osteoarthritis of the knee, supporting previous trial results.

How is Ampio Pharmaceuticals addressing the impact of COVID-19 on trial data?

Ampio conducted a sensitivity analysis to evaluate COVID-19's impact and proposed a modified Intent-to-Treat population for efficacy assessment.

What are the next steps for Ampio Pharmaceuticals regarding FDA approval?

Ampio has submitted a Type C meeting request to the FDA and expects to provide clarity on the AP-013 data by mid-2022.