Crinetics Presents New Data at ENDO 2024 that Increases Body of Evidence Positioning Once-Daily, Oral Paltusotine as Potential First-Choice Treatment Option for Acromegaly

First Scientific Presentation of PATHFNDR-2 Acromegaly Safety and Efficacy Data Following Positive Topline Announcement, Showing Rapid and Sustained IGF-1 Responses in People Treated with Paltusotine

New PATHFNDR-1 Patient-Reported Outcomes Analysis Showed Paltusotine Lessened Day-to-Day Breakthrough Symptom Exacerbations versus Prior Treatment with Standard of Care Injections, as Assessed by Acromegaly Symptom Diary

Long-Term Data from Open-Label ACROBAT Advance Extension Study Demonstrated Durable Safety, IGF-1, and Symptom Control at Up to 42-Months of Paltusotine Treatment

Crinetics Expects to Complete NDA Submission for Paltusotine in 2H 2024

SAN DIEGO, June 03, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today presented findings from its clinical development program evaluating oral, once-daily investigational paltusotine in acromegaly. Data presented included results of the Phase 3 PATHFNDR-2 trial, a new analysis of patient reported outcome (PRO) data from the Phase 3 PATHFNDR-1 trial, and interim long-term efficacy and safety results at 42 months from the open-label ACROBAT Advance extension study. The data were presented today at the Endocrine Society’s Annual Meeting (ENDO2024), with findings from PATHFNDR-1 published as a manuscript in The Journal of Clinical Endocrinology & Metabolism.

“The depth and breadth of our clinical development program for once-daily, oral paltusotine under investigation for the treatment of acromegaly is on display at ENDO 2024, demonstrating its rapid, durable effect on both biochemical and symptom control in these studies,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “Notably, based on patient reported outcome data captured daily by the Acromegaly Symptom Diary, a new analysis from the PATHFNDR-1 trial showed that paltusotine was able to drive significant and important differences in the frequency of acromegaly breakthrough symptom exacerbations compared to prior treatment with standard of care medications. We look forward to submitting a New Drug Application in the second half of this year and potentially changing the acromegaly treatment paradigm.”

Efficacy and Safety of Once-daily Oral Paltusotine in Medically Untreated Patients with Acromegaly: Results from the Phase 3, Randomized, Placebo-controlled PATHFNDR-2 Study (Abstract #MON-694):PATHFNDR-2 was a randomized, double-blind, placebo-controlled trial with a 24-week treatment period, followed by an optional open-label extension study evaluating paltusotine in 111 participants with active acromegaly (IGF-1 > 1.1 ULN) who were not pharmacologically treated. Results demonstrated:

• The study met statistical significance (p