Acer Therapeutics Announces Full Enrollment of Part B in ACER-001 Pivotal Bioavailability and Bioequivalence Trial for Urea Cycle Disorders
Acer Therapeutics Inc. (ACER)
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Source: GlobeNewswire
Part A Successfully Completed and Optimal Formulation of ACER-001 Identified Results of Part B Expected in Q1 2020 with a Planned NDA Submission in Q1 2021 NEWTON, Mass., Dec. 16, 2019 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced full enrollment of Part B of its pivotal trial evaluating bioavailability and bioequivalence of ACER-001 (sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs). Part B was initiated following successful completion of Part A and identification of an optimal ACER-001 formulation. Acer is developing ACER-001 under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. Results from Part A of the trial evaluated bioavailability of three different oral suspension formulations of ACER-001 compared to BUPHENYL® (sodium
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