By Leroy Leo
(Reuters) -Karuna Therapeutics said its lead experimental drug significantly reduced symptoms of schizophrenia in a late-stage trial, sending its shares up 14% in premarket trading on Monday.
The drug, KarXT, met its primary goal with an 8.4-point reduction in a medical scale used to measure the severity of schizophrenia symptoms like delusions, hallucinations and emotional withdrawal among others.
The latest data supports results from previous trials of the drug, including another late-stage trial that showed a 9.6-point reduction in the scale in August.
The data will be a part of the application to the U.S. Food and Drug Administration, which the company expects to file in mid-2023 with an aim for a potential launch in the second half of next year.
“It’s impressive that KarXT still doesn’t have an outright failed trial since this is also not uncommon in schizophrenia,” Oppenheimer analyst Paul Matteis said, calling the latest data “another home run on efficacy”.
While there are several drugs for schizophrenia, including Otsuka Pharmaceutical’s Abilify, Alkermes’ Aristada and Sumitomo Pharma Co’s Latuda, KarXT belongs to a new class of drug called muscarinic.
It is designed to indirectly affect dopamine neurotransmission in brain regions and help treat serious mental illnesses.
Matteis, however, said in a client note that there was a notable higher rate of hypertension in patients on KarXT compared to placebo, but he was not concerned about it for now.
Karuna Therapeutics had in November 2021 partnered with Zai Lab Ltd for development, manufacturing and sale of KarXT in Greater China.
(Reporting by Leroy Leo in Bengaluru; Editing by Sriraj Kalluvila and Arun Koyyur)
