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Sage’s Dalzanemdor Prospects In Doubt After First Mid-Stage Readout

Three More Phase II Trials Under Way

 
• By Mandy Jackson

Dalzanemdor (SAGE-718) showed no difference from placebo in a Phase II Parkinson’s disease study, raising concerns about readouts later this year in Huntington’s and Alzheimer’s diseases.

Question mark heap on table concept for confusion, question or solution
Parkinson's data raise questions about studies in other indications • Source: Shutterstock

Sage Therapeutics, Inc. already is on shaky ground with investors after Zurzuvae (zuranolone) was approved in the US last year for postpartum depression, but not for the larger indication of major depressive disorder. So, when the company reported on 17 April that the next big multi-indication asset in its pipeline, dalzanemdor (SAGE-718), failed in the first of four clinical trials expected to read out in 2024, its stock price dropped sharply.

Key Takeaways

  • Sage’s dalzanemdor failed in the first of four Phase II trial readouts planned this year, showing no difference versus placebo in mild cognitive impairment (MCI) in Parkinson’s disease patients.

Dalzanemdor did not just miss the primary endpoint in the Phase II PRECEDENT trial in the treatment of mild cognitive...

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