TOKYO, Mar 23 (Pulse News Wire) – Chugai Pharmaceutical CO.,LTD. (4519.T) announced today that Roche has decided to discontinue clinical development of GYM329 (emugrobart) for spinal muscular atrophy (SMA) and facioscapulohumeral muscular dystrophy (FSHD).
The decision was based on data evaluations from Phase II/III MANATEE trials targeting SMA and Phase II MANOEUVRE trials focusing on FSHD. Although GYM329 showed potential pharmacological effects through reduced mature myostatin, consistent improvements in muscle mass and motor function across trial participants were insufficient to warrant further advancement to Phase III trials. Chugai emphasized that the discontinuation does not stem from safety concerns; rather, the drug's efficacy did not meet expectations for motor function improvement.
However, ongoing clinical trials for obesity remain unaffected, as the underlying causes and symptoms differ significantly from those of neuromuscular diseases such as SMA and FSHD. Therefore, the Phase II trials for obesity will continue as planned. This development will have no impact on the company’s consolidated earnings forecast for the fiscal year ending December 2026, which was previously disclosed on January 29, 2026.
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