Ampio's Phase I Study for Inhaled Ampion Advances to 3rd Group of COVID-19 Patients with Respiratory Distress

Rhea-AI Summary

Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) announced the advancement of the third group in its Phase I clinical study for inhaled Ampion™ aimed at treating COVID-19 respiratory distress. The Safety Monitoring Committee confirmed that Ampion is safe and well-tolerated based on previous treatment groups. The trial, enrolling 40 patients, compares inhaled Ampion to Standard of Care, focusing on safety as its primary endpoint. FDA has cleared multiple administration methods for Ampion, reinforcing its potential in treating various inflammatory diseases. The company is also exploring similar studies overseas.

Positive

• Safety Monitoring Committee confirmed Ampion's safety after first two treatment groups.
• FDA cleared inhalation and intravenous administration methods for Ampion.
• Extensive patent portfolio ensures intellectual property protection until 2032.
• 12-year FDA market exclusivity expected upon approval as a novel biologic.

Negative

• None.

ENGLEWOOD, Colo., Nov. 17, 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 that the third group in the Phase I inhaled Ampion™ clinical study is being treated following clearance by the Safety Monitoring Committee (SMC) who found Ampion to be safe and well-tolerated after reviewing the results from the first and second treatment groups.

Michael Macaluso, Ampio's, President and CEO, clarified specific features of this clinical trial:

• "Ampion is being administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, using a hand-held nebulizer for COVID-19 patients early in the disease and non-invasive ventilation (face mask) and mechanical ventilation (intubation) if their disease state is more severe.
• This US based study will enroll 40 patients, randomized 1 to 1, inhaled Ampion versus Standard of Care (SOC), with each patient inhaling 8 ml doses of Ampion four (4) times a day for five (5) days. Safety is the primary end point and various measurements indicative of efficacy are secondary endpoints.
• Each of the first three patient groups receiving inhaled Ampion are assessed by the SMC for an additional three days after the 5 day treatment period (as inhalation is a new method of administration of Ampion cleared for clinical use by the FDA) and if no safety concerns arise for this third group, the trial will accelerate to complete enrollment of the remaining 34 patients at the speed of recruitment."

Mr. Macaluso further noted, "The FDA has now cleared two types of administration of Ampion (i.e., inhalation and intravenous) for treatment of COVID-19 patients. In addition, a third method of administration, direct injection into the knee for patients suffering from severe osteoarthritis of the knee, supports the Company's belief that Ampion is a platform drug, potentially useful for a number of inflammatory diseases throughout the body. We are continuing our  investigation of conducting a similar inhalation study overseas that we expect will  run in close proximity with the US study. We will provide an update with more information as it develops."

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 is the latest update on Ampio Pharmaceuticals' clinical trial for inhaled Ampion?

Ampio Pharmaceuticals announced that the third group in its Phase I clinical study for inhaled Ampion has commenced treatment after confirming safety from earlier groups.

What are the key findings from the Safety Monitoring Committee regarding Ampion?

The Safety Monitoring Committee found that Ampion is safe and well-tolerated based on the results from the first and second treatment groups in the clinical study.

How many patients are being enrolled in the inhaled Ampion trial?

The trial will enroll a total of 40 patients, randomized to receive either inhaled Ampion or Standard of Care.

What are the primary and secondary endpoints of the inhaled Ampion study?

The primary endpoint is safety, while various measurements indicative of efficacy serve as secondary endpoints.

What potential market advantages does Ampion have?

Ampion has an extensive patent portfolio and is expected to receive 12-year FDA market exclusivity upon approval as a novel biologic.