The initial findings of a Phase 2 study have shown that the investigational drug paltusotine may significantly reduce both the frequency and intensity of bowel movements and flushing symptoms experienced by those living with carcinoid syndrome.
In addition to reducing two of the key symptoms of the syndrome, the results of the study showed that paltusotine was well-tolerated by trial participants, according to Crinetics Pharmaceuticals, Inc., which developed and is testing the investigational compound.
Paltusotine is an oral, once-daily investigational compound being developed to treat carcinoid syndrome as well as the hormonal disorder called acromegaly.
The paltusotine trial consists of a randomized treatment phase followed by a long-term extension phase. During the open-label treatment phase of the study, 36 participants were randomized to receive either 40 mg or 80 mg of paltusotine daily.
The initial trial findings indicate that:
- Paltusotine resulted in a 65% reduction in bowel movement frequency and 65% reduction in flushing episodes, a finding 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
- The majority of treatment-related adverse events were mild-to-moderate
- The most frequently reported adverse events included diarrhea, headache, and abdominal pain.
Crinetics Pharmaceuticals, Inc., focuses on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company expects to complete the treatment phase of the study in the first quarter of 2024 before moving into phase 3 trial.
For more information about the paltusotine study, visit clinicaltrials.gov.