Ampio Selects Ascendia Pharmaceuticals, Inc. to Provide CDMO Services to Support Clinical Development of OA-201

6 October 2023

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.

For more information, contact:

Ampio Pharmaceuticals, Inc.
Michael A. Martino
Chief Executive Officer
mmartino@ampiopharma.com

SOURCE Ampio Pharmaceuticals, Inc.