Benzinga | Jun 28, 2021 07:35AM EDT

Crinetics Pharmaceuticals Announces Dosing of First Patient in Phase 3 PATHFNDR-1 Study Evaluating Oral Paltusotine for the Treatment of Acromegaly

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 the randomization of the first acromegaly patient in its Phase 3 clinical trial of paltusotine, PATHFNDR-1. This trial will be one of two planned Phase 3 studies assessing the safety and efficacy of once-daily oral paltusotine in acromegaly patients that together will evaluate paltusotine in a wide cross section of acromegaly patients. If successful, Crinetics believes its Phase 3 program could support registration of paltusotine in the United States and Europe for all acromegaly patients who require pharmacotherapy.

"The dosing of the first patient in the PATHFNDR program represents a key step in paltusotine's clinical development. We believe that, if successful, these trials would support paltusotine's approval as the first nonpeptide, oral alternative to the injected standard of care for the treatment of acromegaly," said Alan Krasner, M.D., Crinetics' chief medical officer. "Our goal for paltusotine is to provide a once daily oral option for acromegaly patients that can help control excess hormone levels while at the same time relieving the burden and pain of currently available therapies."

"This is the first product candidate in our emerging endocrine pipeline to reach Phase 3 clinical trials. I am very proud of the team that created paltusotine and facilitated its development to this stage," added Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We are now focused on completing these trials and, if approved, making paltusotine available to acromegaly patients around the world. At the same time, we remain committed to advancing our pipeline of nonpeptide product candidates for endocrine patients and investing in our small molecule discovery approach to continue to grow that pipeline."