Sept. 9 Clinical Quick Takes: Translate to discontinue enzyme deficiency candidate; plus Janssen, Neurotrope, AMT and Cassava
Translate dropping enzyme deficiency program
Translate Bio Inc. (NASDAQ:TBIO) fell $0.73 to $9.25 in after-hours trade Monday after the company said that it is discontinuing development of MRT5201 for ornithine transcarbamylase deficiency based on preclinical safety and PK profiles for the lipid nanoparticle-encapsulated mRNA. Translate will prioritize pulmonary programs including MRT5005, an mRNA therapy encoding functional CFTR in a Phase I/II cystic fibrosis trial for which data are expected next year.
Spravato reduces depression in suicidal patients
Janssen Pharmaceuticals Inc.'s Spravato esketamine met the primary endpoint in the Phase III ASPIRE I and II trials to treat moderate to severe major depressive disorder patients with suicidal intent. Spravato plus standard of care therapy reduced depression symptoms, measured on the Montgomery-Åsberg Depression Rating Scale (MADRS), vs. placebo plus SOC 24 hours after the first dose (p=0.006 in both trials). The Johnson & Johnson (NYSE:JNJ) unit presented data at the European College of Neuropsychopharmacology meeting in Denmark. Spravato is approved for treatment-resistant depression...