SAN DIEGO, Dec. 18, 2023 (GLOBE NEWSWIRE) — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced positive initial findings from its ongoing open-label Phase 2 carcinoid syndrome (CS) study of paltusotine, an oral, once-daily investigational compound being developed for the treatment of acromegaly and CS.

“We are very encouraged by these strong initial findings in our Phase 2 study of paltusotine in people with carcinoid syndrome,” said Scott Struthers, Ph.D., founder and chief executive officer 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. Further, paltusotine was well-tolerated and the overall pharmacokinetic profile was consistent with prior studies. 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.”

Key Highlights from Ongoing Open-label Phase 2 Study of Paltusotine in Carcinoid Syndrome:

The Phase 2 study is a randomized, open-label, parallel group, multi-center study evaluating the safety, tolerability, pharmacokinetics, and efficacy of paltusotine in people living with carcinoid syndrome. Participants were randomized to receive either 40 mg or 80 mg of paltusotine, with the ability to dose titrate based on tolerability or inadequate control of symptoms during the first four weeks of treatment. At the time of this initial data snapshot, safety data were available for 27 participants, 23 of whom had completed at least two weeks of the randomized treatment period and 15 of whom had completed the full 8-week randomized treatment period. Thirteen of the 15 participants (87%) who completed the randomized treatment phase enrolled in the long-term extension phase of the study.

The initial findings indicate that:

Administration of paltusotine resulted in rapid and sustained reductions in bowel movement (BM) and flushing episodes:

1. 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.

2. 65% reduction of flushing frequency for patients with >1/day at baseline
Exposure of paltusotine in people with carcinoid syndrome was consistent with prior clinical studies.

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 the majority of 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 a total of 36 participants enrolled. Topline data from the complete study is expected in the first half of 2024.

There is no detail of the the Phase 3 trial yet but it is expected to be larger in patient participation and the acceptance criteria may be similar to Phase 2 linked below.  I’ll post the Phase 3 clinical trial document in due course.