ENGLEWOOD, Colo., Sept. 21, 2020 /PRNewswire/ — Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE) (the "Company")
announces the receipt of an Investigational New Drug ("IND") from
the U.S. Food and Drug Administration ("FDA"), allowing the Company
to proceed with clinical trials for the use of
AmpionTM as an inhalation therapy for respiratory
distress due to COVID-19 infection.
Expanding on the recently successful Phase I trial that
administered Ampion intravenously to COVID-19 patients
(https://ampiopharma.com/news/ampio-reports-positive-results-in-early-trial-for-iv-ampion-treatment-in-covid-19-patients/),
the current Phase I trial of inhaled Ampion will be a multi-center,
randomized, controlled trial for a total of 40 patients, and 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. Ampion will be
delivered by inhalation, allowing the drug to directly target and
attenuate inflammation in the lungs that can lead to respiratory
failure. This approved clinical trial will study the effects of
inhaled Ampion while emphasizing early intervention treatment
throughout the clinical progression of COVID-19 infection. Ampion
will be delivered by a hand-held nebulizer for inhalation by
patients with less severe cases of respiratory illness and through
mechanical ventilators to those patients who have progressed to
severe respiratory distress syndrome ("ARDS").
The FDA relied on safety and efficacy data from comprehensive
preclinical laboratory studies provided by Ampio to
Grant this IND. Toxicology studies demonstrated that Ampion is
safe for inhalation, and extensive laboratory data indicates that
Ampion can effectively reduce signaling proteins responsible for
tissue damage and pulmonary complications. These studies also
revealed that Ampion can effectively increase signaling molecules
required for tissue repair and healing in the lungs. Ampion's
mechanism of action may interrupt the pulmonary disease process and
provide much needed relief and recovery for patients suffering from
shortness of breath and respiratory illness related to COVID-19
infection.
The current IND along with Ampio's active INDs for the
introduction of Ampion intravenously and by intraarticular
injection builds upon Ampion's potential as a platform drug,
treating multiple conditions characterized by
inflammation. A recurring theme across all clinical
trials with Ampion is that this anti-inflammatory biologic has
been safe and well-tolerated with no serious drug related adverse
events.
About Inflammatory Diseases
Inflammation refers to a
biological response to stimuli interpreted by the body to have a
potentially harmful effect. Inflammatory disorders that result in a
dysregulated immune response by attacking the body's own cells or
tissues may result in chronic pain, tissue damage and loss of
function. Inflammation plays a major role in many disease
processes including allergy, asthma, autoimmune disorders such as
hepatitis, inflammatory bowel disease, transplant rejection and
more.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals,
Inc. is a development stage biopharmaceutical company primarily
focused on the development of Ampion to treat prevalent
inflammatory conditions for which there are limited treatment
options. Ampio's lead product candidate, Ampion, is backed by
an extensive patent portfolio with intellectual property protection
extending through 2032 and is 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," "may," "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, the timing and
outcome of clinical trials, and 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.
Company Contact
Daniel G. Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.