Crinetics Announces Positive Topline Results from Phase 2 Trial of Paltusotine for the Treatment of Carcinoid Syndrome

13 March 2024 | Wednesday | News

Paltusotine Demonstrates Rapid Reductions in Carcinoid Syndrome Symptoms, Promising Efficacy, and Safety Profile
Image Source | Public Domain

Image Source | Public Domain

Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company specializing in endocrine diseases and tumors, revealed encouraging topline findings from its Phase 2 trial investigating paltusotine for the treatment of carcinoid syndrome. Paltusotine, an oral, once-daily investigational compound, exhibited rapid and sustained reductions in symptoms associated with carcinoid syndrome, including flushing episodes and bowel movements.

Key findings from the Phase 2 study include:

  • Efficacy: Paltusotine showcased rapid and sustained reductions in flushing episodes and bowel movements, with significant reductions observed within two weeks of treatment initiation and maintained through the eight-week study period. Notably, there was a 63% reduction in mean flushing frequency and a 60% reduction in mean excess bowel movement frequency among participants.

  • Safety and Tolerability: Paltusotine was generally well-tolerated, with no severe or serious treatment-related adverse events reported. The most commonly reported adverse events included diarrhea, abdominal pain, nausea, and headache. Importantly, adverse event profiles were similar across different dosage groups.

  • Pharmacokinetics: The overall pharmacokinetic profile of paltusotine in patients with carcinoid syndrome remained consistent with expectations based on previous studies conducted in healthy volunteers.

  • Patient Experience: Patients experienced significant improvements in symptoms regardless of whether they were treatment-naïve or transitioning from prior somatostatin receptor ligand therapy. Additionally, biomarker levels of serotonin and 5HIAA provided additional evidence of paltusotine activity in carcinoid syndrome.

Dr. Scott Struthers, founder and CEO of Crinetics Pharmaceuticals, expressed satisfaction with the positive outcomes, emphasizing their potential to bring substantial benefits to patients grappling with the debilitating symptoms of carcinoid syndrome. He outlined plans to expedite Phase 3 studies and engage with the FDA to align on study design, aiming to commence Phase 3 by year-end.

Dr. Aman Chauhan from the Sylvester Comprehensive Cancer Center at the University of Miami, an investigator on the study, hailed the results as highly encouraging and highlighted the urgent need for improved treatment options for patients with neuroendocrine tumors experiencing carcinoid syndrome.

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