ENGLEWOOD, Colo., Aug. 19, 2020 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE), a
biopharmaceutical company focused on the advancement of
immunology-based therapies for prevalent inflammatory conditions,
provides updates regarding the following clinical trials:
- Ampion Phase I clinical trial for intravenous ("IV")
treatment of COVID-19 patients:
The initial safety
assessments are complete and the trial is cleared to enroll the
remaining patients for the Phase I US based clinical trial
evaluating a 5-day IV AmpionTM treatment for
COVID-19 patients requiring supplemental oxygen. The results were
reviewed by an independent Safety Monitoring Committee,
comprised of four physicians, who found Ampion to be safe and
well-tolerated, and who authorized the trial to move to
completion. Additional details of the trial can be found on
clinicaltrials.gov (NCT04456452).
- Ampion IND application for inhalation treatment of COVID-19
patients:
The FDA requested comprehensive tests on the
safety of nebulized Ampion at various doses. The results
of these tests have been reviewed by independent toxicologists who
found no evidence of toxicity in preclinical trials, even at
extreme doses, and this extensive data has been submitted to the
FDA. A clinical trial protocol for treating patients who have
respiratory distress due to COVID-19 with nebulized Ampion has
already been submitted and is
being reviewed by the FDA. The addition of this safety
data is expected
to complete our IND application.
About Ampio Pharmaceuticals
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," "may," 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, 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
Dan Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
Ampio Pharmaceuticals, Inc.
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SOURCE Ampio Pharmaceuticals, Inc.