Data from the Phase 1b trial suggest that a lower dose ratio of trospium to xanomeline, compared to the ratios used in Phase 1 trials in healthy adult volunteers and in the Phase 2 EMERGENT-1 trial evaluating KarXT in adults with schizophrenia, was better tolerated by healthy elderly volunteers.
“We are encouraged that the data from our Phase 1b healthy elderly volunteers trial suggest that potentially therapeutic doses of KarXT can be administered to elderly adults while maintaining a favorable tolerability profile,” said Stephen Brannan, M.D., chief medical officer of Karuna Therapeutics. “Results from the third cohort provide additional data as we finalize the dosing and titration protocol for our Phase 2 trial in dementia-related psychosis.”
“The results from the Phase 1b trial in healthy elderly volunteers, as well as a prior Phase 2 study demonstrating the potential of xanomeline to treat and prevent psychosis in patients with Alzheimer’s disease, give us confidence in the potential utility of KarXT for the treatment of dementia-related psychosis,” added Steve Paul, M.D., chief executive officer, president and chairman of the board of Karuna Therapeutics. “These results support the progression of KarXT into a Phase 2 clinical trial for the treatment of dementia-related psychosis, which we plan to commence in the first half of 2022.”
About KarXT
KarXT, a proprietary oral modulator of muscarinic cholinergic receptors, is Karuna’s lead product candidate. It combines xanomeline, a novel muscarinic agonist, with trospium, an FDA-approved muscarinic antagonist that does not appreciably cross the blood-brain-barrier, to preferentially stimulate muscarinic receptors in the central nervous system. This novel product candidate, if approved, has the potential to usher in a new treatment paradigm and dramatically impact patients with schizophrenia and other psychotic disorders by providing a differentiated mechanism of action relative to current D2 dopamine and serotonin receptor-targeting antipsychotic drugs.
About Karuna
Karuna Therapeutics is a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by these severe and disabling disorders. Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives. For more information, please visit www.karunatx.com.
Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about the timing of advancing of our planned clinical trials and regulatory filings, our goals to develop and commercialize our product candidates, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to
