ENGLEWOOD, Colo.,
Sept. 21, 2021 /PRNewswire/ -- Ampio Pharmaceuticals
(NYSE American: AMPE), a biopharmaceutical company focused on the
advancement of immunology-based therapies for prevalent
inflammatory conditions, today announced regulatory approval from
the Drugs Controller General of India (DCGI) of the Central Drugs Standard
Control Organization (CDSCO) in the Phase II AP-019 clinical trial
in India. The study will utilize
inhaled Ampion™ to treat those suffering from respiratory distress
due to COVID-19.
Following presentation of Ampion to a Subject Expert Committee
(SEC) established by the DCGI, the AP-019 treatment protocol was
approved with no recommended changes.
"More than a year and a half into the pandemic, healthcare
practitioners still lack effective and easy-to-use therapies to
treat the severe and often fatal respiratory distress experienced
by many COVID-19 patients," said Mike
Macaluso, President & CEO of Ampio. "We are grateful for
the DCGI's swift attention and believe their decision underscores
the critical medical need for Ampion as a potential treatment
option."
India has experienced over 33
million infections and over 440 thousand reported
coronavirus-related deaths since the pandemic began, making it the
country with the largest number of COVID-19 infections and deaths
in the Middle East and
Asia. While new infections are at
10% of their peak in early May, COVID-19 remains a continuing
health threat in India.
As an immunomodulatory agent with anti-inflammatory effects,
Ampion interrupts the hyperactive immune response associated with
COVID-19 and, as such, may improve the clinical outcome for
patients suffering from its complications. Directly administering
Ampion to patients by inhalation allows the drug to directly target
and attenuate inflammation in the lungs.
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 COVID-19
respiratory distress by 78% over the Standard of Care (SOC) for
patients suffering from respiratory distress due to COVID-19.
Specifically, mortality in the SOC group was 24%, while in the
group treated with SOC and Ampion, mortality was only 5%.
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
katiek@gregoryfca.com
610-731-1045
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SOURCE Ampio Pharmaceuticals, Inc.