ENGLEWOOD, Colo., Oct. 28, 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 the Company has begun recruiting and enrolling patients in a Phase I multi-center, randomized, controlled trial for a total of 40 patients that will assess the safety and efficacy of inhaled Ampion added to the standard of care ("SOC") for COVID-19 infected patients hospitalized for respiratory distress. Dosing of patients will begin at Penrose Hospital in Colorado Springs, Colorado and will expand enrollment to other hospitals in the near future.
Michael Macaluso, Ampio's CEO clarified specific features of this clinical trial:
- Ampion will be administered to COVID-19 patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, as administered by either a hand-held nebulizer for COVID-19 patients with mild to moderate disease, or by non-invasive ventilation (face mask) and mechanical ventilation (intubation) in patients impacted with more severe disease.
- This US study will enroll 40 patients, randomized 1 to 1, Ampion in addition to SOC versus SOC alone. Each patient in the treatment arm will inhale 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.
- The first three patients inhaling Ampion will be assessed by a Safety Monitoring Committee for an additional three days after the 5 day treatment period, as required by the protocol, as inhalation is a new method of administration of Ampion approved for clinical use by the FDA. If no safety concerns arise, then open enrollment at the speed of recruitment will follow for the remaining patients.
Mr. Macaluso further noted " The FDA has now granted two separate INDs and protocols of administration of Ampion for the treatment for COVID-19 patients, inhalation and intravenous, and a third method of administration, by direct intra-articular injection into the knee for patients suffering from severe osteoarthritis-of-the-knee. These various indications and modes of administration of Ampion strengthens the Company's belief that Ampion is a platform drug, which is potentially useful for a number of additional inflammatory conditions. We are currently investigating the possibility of conducting a series of similar inhalation studies world-wide that would run concurrently with the US study. We will provide an update to our shareholders 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 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.
Dan Stokely, CFO
Phone: (720) 437-6500
Ampio Pharmaceuticals, Inc.
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SOURCE Ampio Pharmaceuticals, Inc.