Karuna Therapeutics ( KRTX Quick Quote KRTX - Free Report) announced positive results from a phase Ib study evaluating the effect of its lead candidate, KarXT, on 24-hour ambulatory blood pressure in adults with schizophrenia.
The primary endpoint of the study was a change in 24-hour average ambulatory systolic blood pressure following eight weeks of treatment with KarXT. Data from the study showed that KarXT demonstrated a mean change of -0.59 mmHg, with the upper bound being 1.60 mmHg. For changes in blood pressure to be clinically meaningful, the change has to be at least 3mmHg per FDA guidance.
The above results demonstrate that KarXT was not associated with sustained increases in blood pressure in schizophrenia patients. It further substantiates the existing clinical data from the EMERGENT program, providing more definitive proof of the cardiovascular safety profile of KarXT in treating schizophrenia.
Year to date, shares of Karuna have lost 14.3% compared with the
industry’s 22.5% decline. Image Source: Zacks Investment Research
The above results will form part of the 120-day safety update to the new drug application (“NDA”)
filed with the FDA in September seeking approval for KarXT to treat schizophrenia in adults. If approved, management expects a commercial launch in second-half 2024.
The NDA is supported by data from the EMERGENT program, which consists of three completed studies –- one phase II study (EMERGENT-1) and two phase III studies (EMERGENT-2 and EMERGENT-3). Data from the EMERGENT program has shown that treatment with Kar-XT addresses schizophrenia symptoms without the common side effects of current treatment options.
Schizophrenia is a mental disorder characterized by recurring episodes of psychosis and requiring long-term treatments with antipsychotic drugs. While the current standard-of-care antipsychotic treatments primarily work by inhibiting dopamine and serotonin receptors, they also carry many debilitating side effects. KarXT works by preferentially stimulating M1 and M4 muscarinic receptors in CNS. A stimulation in these receptors demonstrated improvements in psychosis and cognition.
Apart from schizophrenia, Karuna Therapeutics is developing KarXT as a potential treatment for dementia-related psychosis (DRP). The company initially focused on developing KarXT for treating psychosis in Alzheimer’s disease (AD), one of the most prevalent subtypes of DRP, as part of the ADEPT clinical program. Two studies in the ADEPT program are ongoing, with a third study expected to start before this year’s end. The top-line data from these studies are expected by 2025.
Zacks Rank & Stocks to Consider
Karuna currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks in the overall healthcare sector include
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