Ampio Pharmaceuticals Announces Patient Randomization and Dosing in AP-019 Phase II Study of Inhaled Ampion in COVID-19 Respiratory Distress

Rhea-AI Summary

Ampio Pharmaceuticals (NYSE American: AMPE) announced the initiation of patient randomization and dosing in its multi-center AP-019 Phase II clinical trial for inhaled Ampion™ to treat respiratory distress from COVID-19. Following strong Phase I results showing a 78% reduction in all-cause mortality, the Phase II trial aims to confirm these outcomes. The company has also received FDA approval to expand the study to India amid rising COVID-19 cases. Ampion is positioned as an immunomodulatory agent to improve clinical outcomes for patients with severe respiratory issues.

Positive

• Phase I trial showed 78% reduction in all-cause mortality in COVID-19 patients.
• FDA approved expansion of AP-019 study to India.

Negative

• None.

ENGLEWOOD, Colo., June 25, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced randomization and dosing of patients in its multi-center AP-019 Phase II clinical trial, using inhaled Ampion™ in the treatment of respiratory distress due to COVID-19, is underway.

"We saw strong, positive results in our Phase I trial, reducing all-cause mortality in COVID-19 respiratory distress by 78%. If this Phase II study further confirms the efficacy results seen in our Phase I  study, I can envision moving forward quickly with an application for Emergency Use Authorization for Ampion in treating patients suffering from respiratory distress due to COVID-19," said Michael Macaluso, President and CEO of Ampio.

As an immunomodulatory agent with anti-inflammatory effects, Ampion interrupts the hyperactive immune response associated with COVID-19 and may improve the clinical outcome for patients suffering from its complications.

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 patients suffering from COVID-19 respiratory distress by 78% over the Standard of Care (SOC). Specifically, mortality in the SOC group was 24%, while in the group treated with Ampion, mortality was only 5%.

"Roughly 300 people per day are dying of COVID-19 in the U.S.," Macaluso continued, "with a seven-day average of 10,000 per day worldwide. There is a perception the vaccine rollout has ended the pandemic, but COVID-19 is likely to remain a concern for some time to come, and physicians need tools to treat it."

Ampio also recently received approval from the FDA to expand the AP-019 study to India, which has recently seen a dramatic surge in COVID-19 cases.

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
katie@gregoryfca.com
610-731-1045

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SOURCE Ampio Pharmaceuticals, Inc.

FAQ

What were the results of Ampio Pharmaceuticals' Phase I trial for Ampion?

The Phase I trial demonstrated a 78% reduction in all-cause mortality in COVID-19 respiratory distress patients compared to the Standard of Care.

When did Ampio Pharmaceuticals announce the start of its Phase II clinical trial?

Ampio Pharmaceuticals announced the initiation of the AP-019 Phase II clinical trial on June 25, 2021.

What is the goal of the AP-019 Phase II trial?

The goal is to confirm the efficacy results seen in the Phase I trial for inhaled Ampion in treating respiratory distress due to COVID-19.

What expansion approval did Ampio Pharmaceuticals receive for its clinical trial?

Ampio received FDA approval to expand the AP-019 study to India, where COVID-19 cases have surged.

What is Ampion and how does it work?

Ampion is an immunomodulatory agent with anti-inflammatory effects aimed at improving outcomes for patients suffering from respiratory complications due to COVID-19.