Ampio's Phase I Study For Inhaled Ampion Advances To 2nd Group Of COVID-19 Patients With Respiratory Distress

Rhea-AI Summary

Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) announced the advancement of the second group in its Phase I inhaled Ampion™ clinical study for COVID-19 patients. Following a positive review from the Safety Monitoring Committee, Ampion was deemed safe and well-tolerated. The study will involve 40 patients, comparing inhaled Ampion with Standard of Care. Treatment consists of 8 mL doses inhaled four times daily for five days. Ampion's administration methods have received FDA clearance, indicating its potential for various inflammatory conditions, supported by a robust patent portfolio.

Positive

• Phase I inhaled Ampion™ study progresses to second patient group after safety clearance.
• Ampion deemed safe and well-tolerated, allowing for further patient enrollment.
• FDA clearance for both inhalation and intravenous administration methods.
• Strong patent portfolio providing intellectual property protection until 2032.

Negative

• None.

ENGLEWOOD, Colo., Nov. 10, 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 second 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 treatment group.

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

• "Ampion will be 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 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 will be 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, open enrollment at the speed of recruitment will follow the remainder of the 40 patients."

Mr. Macaluso further noted, "The FDA has now cleared two types of administration of Ampion for treatment of COVID-19 patients, inhalation and intravenous. 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 currently investigating a similar inhalation study overseas that we are planning to 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

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SOURCE Ampio Pharmaceuticals, Inc.

FAQ

What is the significance of the Phase I inhaled Ampion study for Ampio Pharmaceuticals (AMPE)?

The Phase I inhaled Ampion study's advancement indicates progress in developing a treatment for COVID-19, with potential implications for the company's future success.

How many patients are involved in the Ampion inhalation study announced by Ampio Pharmaceuticals (AMPE)?

The study will enroll 40 patients, randomized to receive inhaled Ampion or Standard of Care.

What were the findings of the Safety Monitoring Committee regarding the inhaled Ampion treatment?

The Safety Monitoring Committee found Ampion to be safe and well-tolerated, enabling the trial to proceed to the second patient group.

What are the dosing details for the inhaled Ampion treatment in the clinical trial?

Patients will inhale 8 mL doses of Ampion four times a day for five days.