Ampio Pharmaceuticals Receives Approval from the Drugs Controller General of India (DCGI) to Commence AP-019 Phase II Study in India

Rhea-AI Summary

Ampio Pharmaceuticals (AMPE) has received regulatory approval from India's Drugs Controller General (DCGI) for its Phase II clinical trial (AP-019) utilizing inhaled Ampion™ to treat respiratory distress in COVID-19 patients. This comes after the successful Phase I trial, which demonstrated a 78% reduction in all-cause mortality compared to standard care. India continues to face health challenges with over 33 million infections, making the approval timely. Ampion aims to target inflammation directly in the lungs, addressing a critical medical need as COVID-19 remains a health threat.

Positive

• Regulatory approval from DCGI for Phase II clinical trial of Ampion in India.
• Strong Phase I trial results showing 78% reduction in all-cause mortality for COVID-19 patients.

Negative

• None.

ENGLEWOOD, Colo., Sept. 21, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced regulatory approval from the Drugs Controller General of India (DCGI) of the Central Drugs Standard Control Organization (CDSCO) in the Phase II AP-019 clinical trial in India. The study will utilize inhaled Ampion™ to treat those suffering from respiratory distress due to COVID-19.

Following presentation of Ampion to a Subject Expert Committee (SEC) established by the DCGI, the AP-019 treatment protocol was approved with no recommended changes.

"More than a year and a half into the pandemic, healthcare practitioners still lack effective and easy-to-use therapies to treat the severe and often fatal respiratory distress experienced by many COVID-19 patients," said Mike Macaluso, President & CEO of Ampio. "We are grateful for the DCGI's swift attention and believe their decision underscores the critical medical need for Ampion as a potential treatment option."

India has experienced over 33 million infections and over 440 thousand reported coronavirus-related deaths since the pandemic began, making it the country with the largest number of COVID-19 infections and deaths in the Middle East and Asia. While new infections are at 10% of their peak in early May, COVID-19 remains a continuing health threat in India.

As an immunomodulatory agent with anti-inflammatory effects, Ampion interrupts the hyperactive immune response associated with COVID-19 and, as such, may improve the clinical outcome for patients suffering from its complications. Directly administering Ampion to patients by inhalation allows the drug to directly target and attenuate inflammation in the lungs.

The company initiated the AP-019, double-blind, placebo-controlled Phase II trial, utilizing inhaled Ampion following the strong top-line results achieved from its AP-014 Phase I trial. On April 27, 2021, the company reported the earlier Phase I study not only met its primary endpoint of safety and tolerability, but top-line results also showed that Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78% over the Standard of Care (SOC) for patients suffering from respiratory distress due to COVID-19. Specifically, mortality in the SOC group was 24%, while in the group treated with SOC and Ampion, mortality was only 5%.

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 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.

Media Contact
Katie Kennedy
katiek@gregoryfca.com
610-731-1045

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SOURCE Ampio Pharmaceuticals, Inc.

FAQ

What clinical trial did Ampio Pharmaceuticals announce approval for?

Ampio Pharmaceuticals announced approval for the Phase II AP-019 clinical trial in India.

What is the significance of the AP-019 trial for COVID-19 patients?

The AP-019 trial aims to test inhaled Ampion™ for treating respiratory distress in COVID-19 patients, addressing a critical medical need.

What were the results of the Phase I trial for Ampion?

The Phase I trial showed a 78% reduction in all-cause mortality compared to standard care for COVID-19 patients.

How does Ampion work in treating COVID-19?

Ampion acts as an immunomodulatory agent, reducing inflammation in the lungs of COVID-19 patients.

Why is the approval from DCGI important for Ampio Pharmaceuticals?

The approval underscores the urgent need for effective therapies for COVID-19 in India, a country heavily impacted by the pandemic.