SAN DIEGO - Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), a clinical-stage company specializing in endocrine therapies, announced positive results from its Phase 3 study of paltusotine, a treatment for acromegaly. The study, known as PATHFNDR-2, met its primary endpoint with 56% of participants achieving normalized insulin-like growth factor 1 (IGF-1) levels compared to 5% on placebo, a statistically significant outcome (p<0.0001).
The randomized, double-blind, placebo-controlled trial evaluated paltusotine's effectiveness in 111 acromegaly patients not currently under pharmacological treatment. Secondary endpoints, including the reduction of IGF-1 levels and improvement in acromegaly symptoms, also showed statistical significance, bolstering the drug's efficacy profile.
Paltusotine was generally well-tolerated, with no serious adverse events reported. The treatment emergent adverse events (TEAEs) observed were comparable between the paltusotine and placebo groups, with the most common TEAEs being diarrhea, headache, arthralgia, and abdominal pain.
Monica R. Gadelha, M.D., Ph.D., a leading endocrinologist and principal investigator in the PATHFNDR program, expressed optimism about paltusotine's potential to improve patient treatment experiences by offering an oral, once-daily alternative to current therapies.
Crinetics plans to submit a New Drug Application (NDA) to the FDA in the second half of 2024, with hopes of launching the drug in 2025, pending approval. The company's CEO, Scott Struthers, Ph.D., credited the promising results to the collective efforts of patients, clinical staff, and the Crinetics team.
Acromegaly is a rare disease typically caused by a benign pituitary tumor, leading to excessive growth hormone and IGF-1 secretion, which can result in severe systemic complications. Current treatments often involve surgery or injectable therapies, which can be burdensome for patients.
Paltusotine, an oral somatostatin receptor type 2 (SST2) agonist, aims to provide a more convenient treatment option. Its development is part of Crinetics' broader focus on novel therapeutics for endocrine diseases and tumors.
This report is based on a press release statement from Crinetics Pharmaceuticals.
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