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.
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