Ampio Updates Regulatory and Clinical Trial Events

Rhea-AI Summary

Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) provided updates regarding its clinical trials on November 25, 2020. In the Phase I inhaled Ampion™ trial, the third patient group has completed treatment and awaits Safety Monitoring Committee (SMC) review, allowing for accelerated recruitment for the remaining patients. Additionally, the FDA has accepted an amendment for the Phase III osteoarthritis trial, with a formal response expected by year-end. Ampio's lead drug, Ampion, aims to address inflammatory conditions and has a patent protection extending to 2032.

Positive

• Completion of the third patient group in Phase I inhaled Ampion™ trial, moving towards accelerated recruitment.
• FDA acceptance of the amendment for the Phase III osteoarthritis trial, indicating regulatory progress.

Negative

• None.

ENGLEWOOD, Colo., Nov. 25, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today the following updates:

• Patients experiencing respiratory distress due to COVID-19:  In the Phase I inhaled Ampion™ clinical trial (AP-014), the third of three initial safety groups of patients have completed their five days of treatment and three days of follow up for Safety Monitoring Committee (SMC) review (as inhalation is a new delivery method of Ampion cleared for clinical use by the FDA). Once the SMC provides confirmation regarding no safety concerns for this third group, the trial will accelerate to complete the remaining thirty-four patients at the speed of recruitment with additional hospital groups added as required to support enrollment.
• Patients with severe osteoarthritis of the knee (OAK):  The amendment to the OAK Phase III clinical trial (AP-013), that harmonizes the FDA agreement on the Special Protocol Assessment (SPA) with FDA guidance for clinical trials on hold due to COVID-19, has been received by the FDA. The FDA notified the Company that a formal response will be provided by the end of this year.

About Ampio Pharmaceutical
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 United States Private Securities Litigation Reform Act of 1995, as amended to date. 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 the safety and efficacy of Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biologics License Application (BLA), the ability of Ampio to enter into partnering or licensing arrangements, current or future clinical trials, changes in business conditions and similar events (including currently unforeseen risks associated with COVID-19), the possibility that Ampion may be used to treat ARDS induced by COVID-19, Ampio's ability to continue as a going concern and its ability to continue to raise funds using its "at-the-market" equity offering or otherwise, 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, in Ampio's Annual Report on Form 10-K for the period ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made by Ampio with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on these forward-looking statements. 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
Investor Relations
Joe Hassett
joeh@gregoryfca.com
484-686-6600

Media Relations
Sarah May
sarahm@gregoryfca.com 
215-205-1217

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SOURCE Ampio Pharmaceuticals, Inc.

FAQ

What updates were announced by Ampio Pharmaceuticals on November 25, 2020?

Ampio Pharmaceuticals announced updates on its clinical trials, including the completion of the third patient group in the Phase I inhaled Ampion™ trial and the FDA's acceptance of an amendment for the Phase III osteoarthritis trial.

What is the current status of the Phase I inhaled Ampion™ clinical trial?

The third patient group in the Phase I inhaled Ampion™ trial has completed treatment and is awaiting review from the Safety Monitoring Committee.

What is Ampio's lead drug and what is it targeting?

Ampio's lead drug, Ampion, is targeting prevalent inflammatory conditions and is backed by an extensive patent portfolio.

What regulatory progress did Ampio Pharmaceuticals make for their osteoarthritis trial?

The FDA accepted an amendment to the Phase III clinical trial for osteoarthritis, with a formal response expected by the end of the year.