Crinetics Pharmaceuticals Inc.
Crinetics Pharmaceuticals Announces Positive Topline Results for Paltusotine in Phase 3 PATHFNDR-2 Study for Acromegaly Treatment
Summary
Crinetics Pharmaceuticals, Inc. announced positive topline results from the PATHFNDR-2 Phase 3 study evaluating paltusotine, an oral, once-daily investigational treatment for acromegaly. The study met its primary endpoint, with 56% of participants on paltusotine achieving an insulin-like growth factor 1 (IGF-1) level ≤ 1.0 xULN compared to 5% on placebo (p<0.0001). All secondary endpoints also met statistical significance, indicating that paltusotine effectively controlled symptoms and biochemical markers in acromegaly patients. The drug was generally well-tolerated with no serious adverse events reported. These results support the planned submission of a New Drug Application (NDA) to the FDA in the second half of 2024, potentially marking paltusotine as the first once-daily, oral treatment for acromegaly if approved.
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About Crinetics Pharmaceuticals Inc.
Crinetics Pharmaceuticals Inc. is a biopharmaceutical company dedicated to the development of novel therapeutics for patients with endocrine conditions and other rare diseases. The primary focus of Crinetics is on crafting oral therapies that target hormone receptors, offering significant potential to transform the treatment landscape for several disorders. The company's pipeline includes investigational drugs such as paltusotine and CRN04894, aimed at addressing conditions like acromegaly and congenital adrenal hyperplasia, respectively. Crinetics combines cutting-edge drug discovery with an in-depth understanding of disease biology to impact the field of endocrinology substantially. By specializing in small molecules, Crinetics Pharmaceuticals seeks to provide new treatment options that enhance patient quality of life and address significant unmet medical needs. Headquartered in San Diego, California, the enterprise collaborates with academic institutions and industry partners to position its innovations at the forefront of medical advancement. Its work holds significant potential to influence the pharmaceutical industry, contributing to the expansion of targeted therapies within niche markets where few options currently exist.
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