Sage Therapeutics is reeling from another mid-stage setback as its investigational medicine dalzanemdor has missed the mark in a Phase 2 mild cognitive impairment trial.
The drug, an NMDA receptor positive allosteric modulator, was not significantly better than placebo at helping Alzheimer’s patients with mild cognitive impairment or mild dementia improve on a scale known as the Wechsler Adult Intelligence Scale Fourth Edition Coding Test.
Dalzanemdor had failed on the same primary endpoint in another Phase 2 in patients with Parkinson’s disease this spring. At the time, Sage executives tried downplaying any read-through from the Parkinson’s trial to the Alzheimer’s study.
The 12-week trial, dubbed LIGHTWAVE, randomized 174 Alzheimer’s patients. With the primary endpoint miss, Sage said it is discontinuing further development of dalzanemdor, or SAGE-718, in Alzheimer’s.
Sage’s share price $SAGE was down more than 12% before Tuesday’s opening bell.
Next up is Huntington’s disease. The Cambridge, MA-based biotech said it anticipates reporting topline results from another Phase 2 of the investigational drug in patients with cognitive impairment associated with Huntington’s by the end of this year. The drugmaker said that is its lead indication for the medicine.
Barry Greene“While we are disappointed by the results of the LIGHTWAVE Study, we are grateful to participants, investigators, care partners, patient advocates and the Alzheimer’s community who helped make this important research possible,” CEO Barry Greene said in a press release. “We hope our work and these findings help to inform future research.”
It marks another blow to Sage’s pipeline. In July, the company and partner Biogen said their oral medicine SAGE-324 failed a Phase 2 in essential tremor. Biogen walked away from that piece of their pact two months later. Sage continues to evaluate whether SAGE-324 can be applied for other brain conditions.
The duo secured an FDA green light for their drug Zurzuvae in postpartum depression last August, but it was rejected in the broader population of major depressive disorder. Sage is also evaluating a slate of other investigational medicines, including SAGE-689, SAGE-421 and SAGE-319.