Crinetics Pharmaceuticals Inc (NASDAQ:CRNX) released initial findings from its ongoing open-label Phase 2 carcinoid syndrome (CS) study of paltusotine, an oral, once-daily investigational compound being developed for acromegaly and CS.
Carcinoid syndrome occurs when a rare cancerous tumor, called a carcinoid tumor, secretes certain chemicals into your bloodstream, causing a variety of signs and symptoms.
“We are very encouraged by these strong initial findings in our Phase 2 study of paltusotine in people with carcinoid syndrome,” said Scott Struthers, founder and CEO of Crinetics. “These initial results show the potential of paltusotine to significantly reduce both frequency and intensity of bowel movements and flushing, the key carcinoid syndrome symptoms…After completing this Phase 2 study next quarter, we anticipate sharing the results with the FDA to align on the design of a Phase 3 program,” Struthers added.
Related: Crinetics Pharma’s Investigational Candidate Shows Promise In Rare Type Of Hormonal Disorder.
Administration of paltusotine resulted in rapid and sustained reductions in bowel movement (BM) frequency and flushing episodes:
- 65% reduction of excess bowel movements (defined as daily bowel movements above the upper limit of normal, 3/day) for patients with >3/day at baseline
- 65% reduction of flushing frequency for patients with >1/day at baseline.
Paltusotine was generally well-tolerated with a safety profile consistent with prior clinical studies.
- There were no treatment-related severe or serious adverse events (AEs), with most treatment-related AEs being mild to moderate.
- The most frequently reported AEs included diarrhea, headache, and abdominal pain.
Enrollment in the study is complete, with 36 participants enrolled. Topline data from the complete study is expected in the first half of 2024.
Price Action: CRNX shares are up 10.50% at $36.75 on the last check Tuesday.
