Ampio Announces Enrollment Completion for Intravenous ("IV") COVID-19 Clinical Trial & Provides Update on Osteoarthritis of the Knee ("OAK") Clinical Trial

Rhea-AI Summary

Ampio Pharmaceuticals (NYSE American: AMPE) announced the completion of enrollment for its Phase I clinical trial of Ampion™ for IV treatment of COVID-19 patients needing supplemental oxygen. Results are expected shortly from the Safety Monitoring Committee. The ongoing Phase III trial for Ampion in treating severe osteoarthritis of the knee (OAK) was paused due to COVID-19 but is set to resume with a proposal to the FDA planned for early Q4 2020. Ampio's product has the potential for significant market exclusivity upon FDA approval.

Positive

• Enrollment completed for Phase I COVID-19 clinical trial.
• Expected results from the trial will inform future treatment options.
• FDA guidance received to support data evaluation from paused clinical trials.
• Proposed submission to the FDA planned for early Q4 2020.

Negative

• Phase III trial for OAK paused due to logistical issues associated with COVID-19.

ENGLEWOOD, Colo., Sept. 4, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions announces the following: 

• Enrollment has been completed for the Ampion^TM Phase I US based clinical trial for IV treatment of COVID-19 patients requiring supplemental oxygen. The final results from the 5-day treatment will be reported when the Safety Monitoring Committee ("SMC") and the Principal Investigator complete their evaluations which we expect should occur within the next week.
• The current Ampion Phase III clinical trial ("AP-013") of an intra-articular injection of Ampion for treatment of severe OAK, was paused in April 2020 due to significant logistical issues associated with the COVID-19 pandemic. Recently, the FDA has provided guidance specifically designed to assist the pharmaceutical industry with viable options for evaluating data from clinical trials which were adversely impacted by the pandemic. In order to remain in compliance with such guidance, we will continue to remain blinded to the trial results achieved prior to pausing the trial, however, we are confident there will be sufficient objective information to support the submission of our proposal to the FDA. Our plan is to have this proposal completed and sent to the FDA early in the 4^th quarter 2020.

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 2032 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.

Company Contact
Dan Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
Ampio Pharmaceuticals, Inc.

View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-announces-enrollment-completion-for-intravenous-iv-covid-19-clinical-trial--provides-update-on-osteoarthritis-of-the-knee-oak-clinical-trial-301124360.html

SOURCE Ampio Pharmaceuticals, Inc.

FAQ

What were the results of Ampio's Phase I COVID-19 clinical trial?

Results from the Phase I trial will be reported after evaluations by the Safety Monitoring Committee are completed.

What is the status of the Phase III trial for Ampion in treating osteoarthritis?

The Phase III trial was paused in April 2020 but will proceed with a proposal to the FDA planned for early Q4 2020.

What potential market exclusivity does Ampion have if approved?

Ampion could receive 12-year FDA market exclusivity upon approval as a novel biologic.

How does the COVID-19 pandemic impact Ampio's clinical trials?

The pandemic caused significant logistical issues, impacting the ongoing Phase III trial for osteoarthritis.

What is Ampio Pharmaceuticals' focus?

Ampio is focused on developing immunology-based therapies for prevalent inflammatory conditions.