ENGLEWOOD, Colo., Oct. 5, 2023
/PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE)
(the "Company), a pre-revenue stage biopharmaceutical company
focused on development of a potential treatment for osteoarthritis
as part of its OA-201 program, today announced that it has selected
Ascendia Pharmaceuticals, Inc. ("Ascendia") to provide services to
support the clinical development of OA-201, a novel therapeutic for
the treatment of symptomatic osteoarthritis pain. OA-201 consists
of a natural metabolite, formulated as an injectable small molecule
product which has demonstrated an active reduction in pain and
cartilage degradation in relevant pre-clinical studies.
Ascendia, a specialty contract development and manufacturing
organization (CDMO) leader, will provide Ampio with a range of
services including formulation development, process development and
optimization. Ascendia will also provide scale-up, GLP supply and
method validation, culminating in cGMP manufacturing of the product
to support future Phase 1, 2 and 3 clinical trials. Any future
clinical trials to be conducted by Ampio will require Food
& Drug Administration (FDA) approval of an Investigational New
Drug Application (IND).
"After evaluation of many CDMO service providers, we are very
pleased to have selected Ascendia given its strong and broad level
of integrated in-house capabilities which we believe will provide a
solid platform supporting the continued clinical development of
OA-201 for inclusion in future clinical trials," said Michael A. Martino, Ampio's Chief Executive
Officer.
Ampio was advised throughout this process by the Bruder
Consulting & Venture Group (BCVG,) who Ampio have engaged to
assist in the design and execution of its preclinical, clinical,
and manufacturing plans and programs. "We are pleased to
collaborate with Scott Bruder, MD,
PhD, and his team and realize the benefits of their cumulative
years of experience in developing and evaluating drugs and devices
in the osteoarthritis space," said Martino. "This engagement is a
direct application of our virtual organization strategy aimed at
keeping internal, fixed costs low while at the same time accessing
the best talent to help us achieve our goals."
About Ampio Pharmaceuticals, Inc.
Located in Englewood, Colorado,
Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) is focused on
development of a potential treatment for osteoarthritis as part of
its OA-201 program. The OA-201 development program is seeking to
advance Ampio's unique and proprietary small molecule
formulation to take forward through pain and chondroprotection
pre-clinical studies and the next phases of drug development.
Ampio's primary strategy is to address the large and attractive
opportunity for treatment of osteoarthritis of the knee (OAK) and
other joints.
About Ascendia Pharmaceuticals, Inc.
Ascendia Pharmaceuticals, Inc. ("Ascendia") is a specialty CDMO
dedicated to developing and manufacturing enhanced formulations for
pre-clinical and clinical stage drug candidates and marketed drug
products. Ascendia specializes in improving the solubility and
bioavailability of poorly water-soluble drugs using its suite of
nanotechnology platforms. Ascendia formulates products for
injectable, oral, and topical routes of administration. The company
has four technology platforms - EmulSol® for
producing nano-emulsions, AmorSol® for creating
amorphous solid dispersions, NanoSol® for
formulating nano-particles, and LipidSol® for creating
lipid nanoparticles to deliver biologics, peptides, and small
molecules.
About Bruder Consulting & Venture Group
The Bruder Consulting & Venture Group
( www.bruderconsulting.com ) is a full service strategic
advisory firm with expertise in the discovery, development,
clinical design and regulatory approval process of biologics,
devices and combination products in the orthopaedic, wound care and
plastic & reconstructive surgery markets. As veterans of the
business development, licensing, and acquisition process, BCVG
has led or supported more than $2
billion of transactions in the USA and abroad.
Caution Regarding Forward-Looking Statements
All statements other than statements of historical facts
contained in this letter, including statements regarding our
anticipated future clinical developments, future financial
position, and plans and objectives of management for future
operations, 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: we are dependent on the success of our
OA.201 program and we cannot be certain that any preclinical data
will support its further development; we may not be able to manage
third parties to provide timely, high quality, and cost-effective
services to us; our history of losses and our cash resources
available to execute our business plan over the next twelve months
raise substantial doubt about our ability to continue as a going
concern; we are involved in legal proceedings that likely will
adversely affect our financial position and our pursuit of
strategic alternatives; we will need additional capital to fund our
future operations, the OA.201 program, and any strategic
transaction, as well as to assure compliance with the NYSE American
minimum stockholders' equity requirement; we are dependent on
adequate protection of our patent and proprietary rights; the price
of our stock has been and may continue to be extremely volatile; if
we cannot continue to satisfy the NYSE American continued listing
requirements and rules, our securities may be delisted, which could
negatively impact the price of our securities; and other risks
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.
