Sage Axes Parkinson’s Program for Dalzanemdor After Phase II Flop

 Sage Therapeutics faced another disappointment on Wednesday as the company’s oral drug candidate dalzanemdor stumbled in a Phase II trial and is scrapping its Parkinson’s disease program. The announcement resulted in a 19% drop in Sage’s stock price in Wednesday's premarket trading, according to Seeking Alpha. 

In the Phase II PRECEDENT study, 86 patients with Parkinson’s disease with mild cognitive impairment were enrolled and randomized to receive the oral drug or placebo. Dalzanemdor, an investigational drug in development for cognitive disorders associated with NMDA receptor dysfunction, did not demonstrate a significant difference in the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test score compared to placebo at day 42. 

Overall, the drug was found to be safe in the mid-stage trial but did not show any meaningful differences over placebo in any of the exploratory endpoints, including a cognition test. Based on the results, Sage said the company “does not plan any further development of dalzanemdor” in Parkinson’s. 

However, the candidate will continue in Phase II studies in Huntington’s disease and another in mild cognition impairment and mild dementia in Alzheimer's disease. Topline results for the studies are expected in mid-2024 and late 2024, respectively. 

While “disappointed” by the PRECEDENT study, Sage CEO Barry Green said in a statement that "these results do not necessarily predict results with dalzanemdor in other neurodegenerative conditions.” Green also clarified that although it is targeting the cognitive impairment associated with these conditions, the underlying pathophysiology between the diseases is distinct. 

Wednesday’s announcement is the latest setback for Sage. 

In August 2023, the company laid off 40% of its staff—around 188 people—after the FDA rejected the major depressive disorder indication for zuranolone. The Biogen-partnered oral medication was approved only in postpartum depression (PPD), the smaller of the two markets the companies had hoped for and is now branded for the indication as Zurzuvae. It's the second PPD drug approved for Sage, the first being an intravenous injection. 

https://www.biospace.com/article/-sage-axes-parkinson-s-program-for-dalzanemdor-after-phase-ii-flop-/