Drug Name: dalzanemdor
CAS:1629853-48-0
R&D Code:SAGE-718
Original Research Company:SAGE Therapeutics
Sage Therapeutics is the developer of the experimental small-molecule medication Dalzanemdor, also known by its development code SAGE-718. The N-methyl-D-aspartate (NMDA) receptor, a crucial receptor in the central nervous system involved in synaptic plasticity, learning, and memory, is positively allosterically modulated by it.
On October 8, 2024, Sage Therapeutics announced the termination of the clinical study of dalzanemdor for the Alzheimer's disease indication based on the results of the LIGHTWAVE study, a double-blind, 12-week, randomized, placebo-controlled clinical trial of 174 participants evaluating the efficacy of the efficacy and safety of Dalzanemdor (first 6 weeks: 1.2 mg orally once daily; 0.9 mg orally once daily for the second 6 weeks) versus placebo for the treatment of mild cognitive impairment or mild dementia due to Alzheimer's disease. The primary endpoint of the study was the change in coded test scores on the fourth edition of the Wechsler Adult Intelligence Scale on treatment day 84 compared to baseline. The results showed that there was no significant difference in the change in the fourth version of the Wechsler Adult Intelligence Scale coded test score for patients in the Dalzanemdor group relative to the placebo group.
On November 20, 2024, Sage Therapeutics announced that its experimental drug dalzanemdor failed to meet its primary objective in a mid-stage study (DIMENSION) in patients with Huntington's disease. Based on these results, the company has decided to terminate the clinical study developing dalzanemdor for the Huntington's disease indication.The DIMENSION study was a 12-week, double-blind, placebo-controlled, Phase 2 study designed to evaluate the impact of dalzanemdor in participants with Huntington's disease-related CI. A total of 189 participants were randomly assigned.The DIMENSION study showed no statistically significant difference between dalzanemdor-treated and placebo-treated participants on the Symbol Digit Transformation Test, a measure of cognitive functioning, on the primary endpoint, Day 84.Dalzanemdor was generally well tolerated and no new safety signals were observed. Most treatment-emergent adverse events were mild to moderate in severity. Secondary endpoint analyses did not show statistically significant or clinically meaningful differences between the dalzanemdor and placebo treatment groups.
