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Crinetics Pharmaceuticals Receives Orphan Drug Designation for Paltusotine for the Treatment of Acromegaly
SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery,
About this update from Crinetics Pharmaceuticals, Inc.
[{"type":"text","content":"SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced that the U.S. Food and Drug Administration (FDA) has granted paltusotine Orphan Drug Designation for the treatment of acromegaly.\n The FDA's Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies the sponsor of the drug for certain development incentives, that may include exemption from FDA prescription drug user fees, financial incentives for qualified clinical development, and seven years of market exclusivity in the U.S. if the treatment is approved. “The orphan drug designation by the FDA for paltusotine to treat acromegaly validates the encouraging clinical data we have seen so far in the Phase 2 ACROBAT Edge clinical trial, and underscores the need for a once daily oral treatment option for patients suffering from this rare disease,” said Michael Monahan, Senior Director of Regulatory Affairs at Crinetics. “Receiving orphan drug designation is another important milestone for the paltusotine program. We look forward to announcing topline results for our ACROBAT clinical program in the fourth quarter of this year and to the initiation of our planned Phase 3 trial for paltusotine in the first half of 2021,” said Ajay Madan, Ph.D., Chief Development Officer of Crinetics. About Paltusotine Paltusotine (formerly CRN00808) is an orally available nonpeptide biased agonist that is designed to be highly selective for the somatostatin type 2 receptor. It was designed by the Crinetics discovery team to provide a once daily oral option for patients with acromegaly and neuroendocrine tumors that are currently treated by injected therapies that sell approximately $3.1 billion annually. Non-clinical chronic toxicology studies are complete and no dose limiting toxicity was identified at the maximum feasible doses in rats and dogs. Crinetics previously completed a Phase 1 trial that showed potent suppression of the growth hormone (GH) axis in healthy v...