Fresh off a meeting with the FDA, Karuna Therapeutics (NASDAQ:KRTX) will advance lead candidate KarXT into Phase 3 development for the treatment of acute psychosis in patients with schizophrenia.
The agency is on board with one successful
late-stage study, along with additional safety data and results from
previously generated trials, to support an NDA filing.
It plans to launch two five-week trials, the first
to launch by year-end. The primary endpoint of the 250-subject study
will be the change in Positive and Negative Syndrome Scale total score
at week 5 versus placebo.
Details of the second efficacy trial will be finalized in Q4 and should launch in H1 2021.
It will also collect long-term open-label safety and tolerability data for up to one year in an outpatient setting.
KarXT is an orally available combination of
xanomeline (a novel muscarinic receptor agonist) and trospium (a
muscarinic receptor antagonist). The company says it has the potential
to be a new treatment option of debilitating CNS disorders but without
the unwanted side effects associated with current antipsychotic
medications.
https://seekingalpha.com/news/3585267-karuna-to-advance-lead-drug-phase-3-for-psychosis-in-schizophrenia-patients
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