Karuna's schizophrenia drug meets goal, safety doubts drag shares
By Leroy Leo
(Reuters) - Karuna Therapeutics said its lead experimental drug significantly reduced schizophrenia symptoms in a late-stage trial, but concerns of it causing hypertension dragged the shares of the drug developer 5% lower 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 data backed results from previous trials, including another late-stage trial that showed a 9.6-point reduction in the scale in August.
However, the latest 256-patient trial also showed that 6% of them who were administered KarXT suffered hypertension as a side-effect, while only 2% of placebo patients faced the issue.
The company said it will start a blood pressure monitoring study for the drug next month.
"On one hand, they're saying there was hypertension and on the other hand, they have to prove that there is no hypertension in that study. So that just complicates the situation a little bit," Guggenheim analyst Yatin Suneja said.
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.
While there are several drugs for schizophrenia including risperidone and olanzapine, KarXT belongs to a new class of drug called muscarinic agonist.
It is designed to indirectly affect dopamine neurotransmission in brain regions and help treat serious mental illnesses.
Company executives said in a conference call with analysts that the drug is better than existing anti-psychotic drugs, which have side-effects like weight gains, metalbolic syndrome and sedation.
Karuna had in November 2021 partnered with Zai Lab Ltd for development, manufacturing and sale of KarXT in Greater China.
(This story has been refiled to add the full name of the new drug class in paragraph 8)
(Reporting by Leroy Leo in Bengaluru; Editing by Sriraj Kalluvila and Arun Koyyur)
