Targeting NMDA in mental health has chalked wins but not universally, as shown by Sage Therapeutics Inc.’s failure of the placebo-controlled phase II Lightwave study testing dalzanemdor in Alzheimer's disease, which missed the primary outcome measure, another bit of bad luck from the company that was disclosed Oct. 8.
Seaport Therapeutics Inc. has followed up its recent fundraiser with an oversubscribed $225 million series B financing that will help set it on the path to a phase IIb study in major depressive disorder. The company’s lead candidate is allopregnanolone, an endogenous neurosteroid that is taken orally and bypasses the liver. Once it is absorbed through the lymphatic system, allopregnanolone enters through a pathway that avoids the liver and the possibility of hepatoxicity and elevated liver enzyme counts, Michael Chen, Seaport’s chief scientific officer, told BioWorld.
After initially reporting that Xanamem failed to meet the primary endpoint in cognitive attention in the phase IIa Xanacidd cognition and depression trial, Actinogen Medical Ltd. CEO Steven Gourlay said a new analysis shows clinically and statistically significant benefits in depression.
After initially reporting that Xanamem failed to meet the primary endpoint in cognitive attention in the phase IIa Xanacidd cognition and depression trial, Actinogen Medical Ltd. CEO Steven Gourlay said a new analysis shows clinically and statistically significant benefits in depression.
A schizophrenia drug in Cerevel Therapeutics Inc.’s lineup understandably stole much of the thunder during coverage of Abbvie Inc.’s takeover late last year to the tune of $8.7 billion, but much further back in the pipeline awaits another potentially lucrative prospect: a kappa opioid receptor antagonist (KORA) for major depressive disorder (MDD).
Wall Street is mulling Intra-Cellular Therapeutics Inc.’s chances of replicating with Caplyta (lumateperone) the path followed by Abbvie Inc. with Vraylar (cariprazine) in major depressive disorder (MDD), and possibly overtaking the latter in the difficult indication.
Alto Neuroscience Inc.’s start this spring of the phase II double-blind, single- and multiple-dose study to test the pharmacodynamics of ALTO-203 in major depressive disorder represents another stake planted in a notoriously difficult indication. But getting attention as well is the push by Los Altos, Calif.-based Alto in post-traumatic stress disorder (PTSD) with a separate compound.
Robust top-line phase III data showed Intra-Cellular Therapies Inc.’s marketed oral atypical antipsychotic drug, Caplyta (lumateperone), achieved statistically significant and clinically meaningful best-in-class results, potentially expanding its reach into the billion-dollar major depressive disorder market. The company’s shares (NASDAQ:ITCI) surged to a 52-week high of $84.89 throughout the day, closing at $79.84, up 23.3%, or $15.08, on April 16.
Preclinical data of rabbits having convulsions has prompted the U.S. FDA to place a clinical hold on Neumora Therapeutics Inc.’s phase I study of NMRA-266 in healthy adults. Neumora said about 30 participants had been dosed so far in the single ascending and multiple ascending dose study, with no evidence of convulsions seen.
