Ampio Pharmaceuticals Receives Approval to Expand Enrollment of its AP-019 Phase II Study to India

Rhea-AI Summary

Ampio Pharmaceuticals (AMPE) has received regulatory approval to expand enrollment in its AP-019 Phase II study to India, aiming to treat respiratory distress from COVID-19 using inhaled Ampion™. This decision is underscored by India's ongoing COVID-19 crisis, with over 3,200 daily deaths reported. The Phase II study follows successful Phase I results that indicated an impressive 78% reduction in all-cause mortality for patients treated with Ampion. Due to political unrest and reduced COVID cases, the study efforts in Israel will be discontinued in favor of focusing on India.

Positive

• Regulatory approval to expand Phase II study to India.
• Potential to address COVID-19 crisis in a densely affected region.
• Successful Phase I trial demonstrated a 78% reduction in mortality.

Negative

• Discontinuation of study efforts in Israel due to political unrest.

ENGLEWOOD, Colo., June 15, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced it has received regulatory approval to expand enrollment of its AP-019 Phase II study to India. The study will utilize inhaled Ampion™ to treat those suffering from respiratory distress due to COVID-19.

"FDA approval to include study sites in India further illustrates the continued need for our therapy," said Michael Macaluso, President and CEO of Ampio. "Currently, India is reporting an average of more than 3,200 daily deaths from COVID-19 and over 94,000 new cases per day. We expect this expansion to shorten the timeline for overall study enrollment and potentially assist one of the world's highest density populations of COVID-19 infections."

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 COVID-19 respiratory distress. Specifically, mortality in the SOC group was 24%, while in the group treated with Ampion, mortality was only 5%.

Due to the ongoing political unrest in Israel and the surrounding region combined with the reduction in COVID cases, the Company has a made a strategic decision to discontinue the AP-019 study efforts in Israel and reallocate and focus these resources to select regions of India and other potential select territories outside the United States, depending on the ongoing magnitude of COVID-19 cases. More information on the Company's COVID-19 trials can be found at: https://ampiopharma.com/pipeline/ampion-and-inflammatory-lung-diseases-covid-19/

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 2035 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
katie@gregoryfca.com
610-731-1045

 

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SOURCE Ampio Pharmaceuticals, Inc.

FAQ

What is Ampio Pharmaceuticals' stock symbol?

Ampio Pharmaceuticals trades under the stock symbol AMPE.

What is the purpose of the AP-019 Phase II study?

The AP-019 Phase II study aims to evaluate the efficacy of inhaled Ampion™ in treating respiratory distress due to COVID-19.

Why did Ampio Pharmaceuticals expand its study to India?

The expansion to India follows the regulatory approval and is a response to the severe COVID-19 crisis in the country.

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

The Phase I trial reported a 78% reduction in all-cause mortality for patients treated with Ampion compared to standard care.

What led to the discontinuation of the study in Israel?

The study in Israel was discontinued due to ongoing political unrest and a reduction in COVID-19 cases.