Paltusotine shows promise in Phase 2 carcinoid syndrome study
© Reuters.
SAN DIEGO – Crinetics Pharmaceuticals, Inc. (NASDAQ: NASDAQ:), a clinical-stage company specializing in endocrine-related therapies, today announced encouraging results from its Phase 2 study of paltusotine in treating carcinoid syndrome. The investigational oral compound demonstrated rapid and sustained reductions in the frequency and severity of both flushing episodes and bowel movements in affected patients.
The trial, which was randomized, open-label, and multi-center, involved 36 participants who were administered either 40 mg or 80 mg of paltusotine daily over an 8-week period. The study allowed for dose adjustments based on tolerability and symptom control. Out of the initial cohort, 30 patients completed the randomized treatment phase, and 26 proceeded to the long-term extension.
Key findings highlighted a 63% decrease in mean flushing frequency and a 60% reduction in excess bowel movements. Moreover, a 61% reduction in flushing severity and a 64% decrease in bowel movement urgency were observed, with these improvements manifesting within two weeks of treatment and persisting through the 8-week period.
The pharmacokinetic profile of paltusotine was consistent with previous studies, and the treatment was generally well-tolerated, with the most common adverse events being diarrhea, abdominal pain, nausea, and headache. No severe or serious treatment-related adverse events were reported.
Crinetics plans to consult with the FDA to discuss the Phase 3 study design and aims to initiate the Phase 3 program by year’s end. The company’s CEO, Scott Struthers, Ph.D., expressed optimism about the study’s confirmation of paltusotine’s potential benefits for patients with carcinoid syndrome, a condition associated with neuroendocrine tumors that often leads to debilitating symptoms like diarrhea and flushing.
The data from this study also support the potential use of paltusotine for conditions beyond acromegaly, for which it is currently undergoing Phase 3 clinical trials. Today, at 4:30 p.m. Eastern Time, Crinetics will host a conference call to discuss the Phase 2 study results in detail.
This report is based on a press release statement from Crinetics Pharmaceuticals.
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