ENGLEWOOD, Colo., Feb. 14,
2024 /PRNewswire/ -- Ampio Pharmaceuticals, Inc.
(NYSE American: AMPE) (the "Company" or "Ampio"), a pre-revenue
stage biopharmaceutical company focused on development of a
potential treatment for osteoarthritis as part of its OA-201
program, today announced the efficacy results from recently
completed nonclinical pre-IND enabling studies with OA-201, Ampio's
only product development opportunity. Ampio reported that the
efficacy results of these studies do not support an Investigational
New Drug ("IND") submission which was anticipated in early 2025.
Specifically, whereas previous smaller studies had demonstrated
that OA-201 showed efficacy versus saline control to reduce pain
and preserve cartilage in nonclinical models of osteoarthritis of
the knee, the pain reduction benefit was not observed in the data
from the recent set of preclinical studies which utilized a larger
population of animal subjects.
"We believe we need to demonstrate a statistically significant
improvement in both pain reduction and cartilage protection to
support the IND and justify the capital necessary to complete the
planned Phase 1/2 trial. The data from the larger nonclinical pain
reduction trial simply do not support the same pain reduction
benefit as was demonstrated in the earlier, smaller,
proof-of-concept trials," said Michael A.
Martino, Ampio's Chief Executive Officer.
The Company's management and the Board are currently assessing
both internal and external options. The Company will be taking
immediate actions to preserve its cash in order to be able to
adequately fund any option identified by the Board.
About Ampio Pharmaceuticals, Inc.
Located in Englewood, Colorado,
Ampio Pharmaceuticals, Inc. is focused on the development of a
potential treatment for osteoarthritis as part of its OA-201
program. The OA-201 development program is exploring Ampio's
unique and proprietary small molecule formulation as a potential
treatment of osteoarthritis of the knee ("OAK") and other
joints.
Caution Regarding Forward-Looking Statements
All statements other than statements of historical facts
contained in this press release, including statements regarding
future expectations, plans and prospects for the Company, including
but not limited to statements about its ability to identify, assess
and execute any internal or external option or realize any value
from its existing assets or business, its ability to preserve cash
in order to adequately fund the Company's operations, the ability
of the Company to continue as a going concern, are forward-looking
statements. Words such as "may", "will", "should", "forecast",
"could", "expect", "suggest", "believe", "estimate", "continue",
"anticipate", "intend", "ongoing", "opportunity", "potential",
"predicts", "seek", "plan," or similar words, or the negatives of
such terms or other variations on such terms or comparable
terminology, typically identify forward-looking statements.
Forward-looking statements are based on certain assumptions and
expectations of future events and trends that are subject to risks
and uncertainties including: (i) the Company's ability to identify,
assess and execute any internal or external option; (ii) the
ability to retain key personnel in order to pursue any internal or
external option; (iii) the adequacy of the Company's capital
resources in light of changing circumstances; and (iv) other
important factors that are described in "Risk Factors" and
elsewhere in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2022 and
subsequent periodic reports filed with the SEC.
We undertake no obligation to update or revise publicly any
forward-looking statements to reflect events or circumstances after
the date of such statements for any reason, except as otherwise
required by law.
For more information, contact:
Ampio Pharmaceuticals, Inc.
Michael A. Martino
Chief Executive Officer
mmartino@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.