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Ampio, Ascendia Partner to Support Clinical Development of OA-201

Ascendia will provide scale-up, GLP supply and method validation, culminating in cGMP manufacturing.

By: Anthony Vecchione

Ampio Pharmaceuticals, Inc., a biopharmaceutical company focused on development of a potential treatment for osteoarthritis, selected Ascendia Pharmaceuticals, Inc. 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 preclinical studies.

Ascendia, a specialty contract development and manufacturing organization (CDMO), 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.

“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 Martino, Ampio’s CEO.


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