Although Karuna Therapeutics (KRTX.O) reported that its lead experimental drug significantly reduced schizophrenia symptoms in a late-stage trial, worries that it might also increase blood pressure caused the company’s shares to fall 5% on Monday.
With an 8.4-point decrease in a medical scale that assesses the severity of schizophrenia symptoms like delusions, hallucinations, and emotional withdrawal, among others, the drug KarXT achieved its main objective.
The information supported the findings of earlier trials, including a subsequent late-stage trial that revealed a 9.6-point scale reduction in August. However, the most recent 256-patient trial also revealed that only 2% of those who received a placebo experienced hypertension, compared to 6% of those who received KarXT.
The business announced that a blood pressure monitoring study for the drug would begin the following month.
“They have to demonstrate that there was no hypertension in that study even though they are claiming there was hypertension in the study. Thus, that only serves to further exacerbate the situation, “Yatin Suneja, a Guggenheim analyst, said.
The company anticipates filing the application with the U.S. Food and Drug Administration in the middle of 2023, with an eye toward a potential launch in the second half of that same year.
While there are a number of medications for schizophrenia, such as risperidone and olanzapine, KarXT is a new type of medication known as a muscarinic agonist.
It is intended to treat severe mental illnesses by indirectly affecting dopamine neurotransmission in various brain regions.
In a conference call with analysts, company executives claimed that the medication is superior to currently available antipsychotic medications, which have side effects like weight gain, metabolic syndrome, and sedation.
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