Astellas Pharma ((ALPMF)), Astellas Pharma ((ALPMY)) announced an update on their ongoing clinical study.
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Astellas Pharma recently updated its clinical study titled ‘A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Assess the Efficacy, Safety and Tolerability of ASP0367 in Participants With Primary Mitochondrial Myopathy.’ The study aimed to evaluate the dose response of Bocidelpar on functional improvement, safety, and tolerability in patients with Primary Mitochondrial Myopathy, a condition affecting muscle function.
The intervention being tested is Bocidelpar, an oral drug intended to improve muscle function in affected individuals. Participants were divided into groups receiving either 30 mg or 75 mg doses of Bocidelpar or a placebo.
This Phase 2 study was designed as a randomized, parallel assignment with triple masking involving participants, caregivers, and investigators. The primary goal was treatment-focused, assessing changes in functional capacity through a 6-minute walk test.
The study began on May 24, 2021, and was terminated with the last update submitted on July 1, 2025. The primary completion and results submission were anticipated in April 2025.
The termination of this study could impact Astellas Pharma’s stock performance, potentially affecting investor sentiment due to unmet expectations in advancing treatment for mitochondrial myopathy. Competitors in the pharmaceutical industry may see this as an opportunity to advance their own treatments in this area.
The study has been terminated, and further details are available on the ClinicalTrials portal.