Positive Phase 2 Results for Paltusotine in Carcinoid Syndrome

Crinetics Pharmaceuticals, a clinical-stage pharmaceutical firm, has announced promising results from its Phase 2 study of paltusotine, an oral medication developed for treating acromegaly and carcinoid syndrome. The open-label trial involved 36 participants and aimed to assess the drug's safety, tolerability, pharmacokinetics, and efficacy. The study showed that paltusotine led to a rapid and sustained decrease in the frequency and severity of flushing episodes and bowel movements, with significant improvements observed within two weeks of treatment initiation.

Two dosages were tested: 40 mg and 80 mg, with some participants titrating their dosage based on tolerability and symptom control. The majority of participants completed the treatment phase, with only a few discontinuing due to various reasons. Notably, the drug demonstrated a favorable safety profile, with no severe or serious adverse events reported, and common side effects being manageable.

Dr. Scott Struthers, CEO of Crinetics, expressed satisfaction with the outcomes, emphasizing the potential benefits of paltusotine for patients suffering from carcinoid syndrome. The company plans to engage with the FDA to discuss the Phase 3 study design and is preparing to initiate it by year-end.

The Phase 2 study's positive findings are particularly encouraging given the unmet need for better treatment options for neuroendocrine tumor patients experiencing carcinoid syndrome. The current standard of care, injectable somatostatin receptor ligand therapies, can be burdensome and may not adequately alleviate symptoms for many patients. Paltusotine, as an oral, once-daily medication, offers a convenient alternative.

Furthermore, biomarker levels of serotonin and 5HIAA provided additional evidence of paltusotine's effectiveness in managing carcinoid syndrome. Dr. Aman Chauhan, an investigator on the study, highlighted the clinical improvements and the critical need for new treatment options, expressing enthusiasm for paltusotine's development.

Crinetics will discuss the study results in a conference call, and the company's drug candidate, paltusotine, is also in Phase 3 trials for acromegaly. Crinetics is dedicated to discovering, developing, and commercializing innovative therapeutics for endocrine diseases and related tumors, with paltusotine representing a significant step forward in addressing the challenges faced by patients with these conditions.