Ampio Provides Update on COVID-19 Clinical Trial Activities

Rhea-AI Summary

Ampio Pharmaceuticals (NYSE American: AMPE) announced updates on its COVID-19 clinical trials. The Phase I trial for intravenous Ampion treatment has completed initial safety assessments and is cleared for further patient enrollment. An independent Safety Monitoring Committee reviewed the results, confirming Ampion's safety. Additionally, the FDA requested further safety testing for nebulized Ampion, with preclinical trials showing no toxicity, and the trial protocol is under FDA review. Ampio's lead drug is positioned for 12-year market exclusivity upon FDA approval.

Positive

• Phase I trial for intravenous Ampion cleared for further patient enrollment.
• Safety Monitoring Committee confirmed Ampion's safety and tolerability.
• Preclinical tests showed no toxicity for nebulized Ampion.
• Potential for 12-year market exclusivity upon FDA approval.

Negative

• None.

ENGLEWOOD, Colo., Aug. 19, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, provides updates regarding the following clinical trials:

• Ampion Phase I clinical trial for intravenous ("IV") treatment of COVID-19 patients:
  The initial safety assessments are complete and the trial is cleared to enroll the remaining patients for the Phase I US based clinical trial evaluating a 5-day IV Ampion^TM treatment for COVID-19 patients requiring supplemental oxygen. The results were reviewed by an independent Safety Monitoring Committee, comprised of four physicians, who found Ampion to be safe and well-tolerated, and who authorized the trial to move to completion. Additional details of the trial can be found on clinicaltrials.gov (NCT04456452).   
• Ampion IND application for inhalation treatment of COVID-19 patients:
  The FDA requested comprehensive tests on the safety of nebulized Ampion at various doses. The results of these tests have been reviewed by independent toxicologists who found no evidence of toxicity in preclinical trials, even at extreme doses, and this extensive data has been submitted to the FDA. A clinical trial protocol for treating patients who have respiratory distress due to COVID-19 with nebulized Ampion has already been submitted and is being reviewed by the FDA. The addition of this safety data is expected to complete our IND application. 

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," "may," 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, and 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.

 

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SOURCE Ampio Pharmaceuticals, Inc.

FAQ

What are the latest updates on Ampio Pharmaceuticals' COVID-19 clinical trials?

Ampio Pharmaceuticals has completed safety assessments for its Phase I trial of intravenous Ampion and is cleared for further patient enrollment.

What were the findings of the independent Safety Monitoring Committee regarding Ampion?

The Safety Monitoring Committee found Ampion to be safe and well-tolerated, allowing the trial to move towards completion.

What is the current status of the nebulized Ampion IND application?

The FDA has requested comprehensive safety tests for nebulized Ampion, which showed no evidence of toxicity in preclinical trials, and the trial protocol is under review by the FDA.

What exclusivity does Ampion have upon FDA approval?

Ampion will be eligible for 12-year market exclusivity under the Biologics Price Competition and Innovation Act if approved.