Business
Crinetics Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Corporate Update
Phase 3 PATHFNDR-1 study topline data expected in 3Q 2023Phase 3 PATHFNDR-2 study topline data expected in 1Q 2024 and enrollment target increased to up to 98
About this update from Crinetics Pharmaceuticals, Inc.
[{"type":"text","content":"Phase 3 PATHFNDR-1 study topline data expected in 3Q 2023Phase 3 PATHFNDR-2 study topline data expected in 1Q 2024 and enrollment target increased to up to 98 per prespecified protocol criteriaPaltusotine’s Phase 2 study in carcinoid syndrome on track for preliminary data in 4Q 2023 SAN DIEGO, May 04, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the first quarter ended March 31, 2023. “We plan to share topline results from PATHFNDR-1 next quarter, which should provide an important look at the impact that paltusotine may have on patients’ lives,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “We designed the two PATHFNDR studies to address both treatment-naïve patients as well as patients who may switch from standard of care, the two patient populations specifically outlined in the recently released draft guidance from the FDA on Developing Drugs for Acromegaly Treatment.” Dr. Struthers continued, “Enrollment in PATHFNDR-2 has benefited from enthusiastic participation of treatment-naïve patients. This enables us to take advantage of a prespecified opportunity to increase the study’s enrollment target while maintaining our estimated timeline of topline data in the first quarter of 2024. We anticipate this will provide an even clearer picture of paltusotine’s potential to treat patients who have been recently diagnosed with acromegaly and could strengthen the competitive position of paltusotine from a market and payer perspective, if approved.” Clinical Program Updates: Paltusotine’s Phase 3 PATHFNDR-1 study: enrollment complete with topline data expected in 3Q 2023. PATHFNDR-1 is a placebo-controlled Phase 3 clinical study of once-daily, oral paltusotine in participants with acromegaly switching from standard-of-care peptide depots. It is designed to support an indication for the maintenance of acromegaly treatment. The study enrolled participants with acromegaly who were biochemically controlled (IGF-1 ≤ 1.0x upper limit of normal) on octreotide or lanreotide depot monotherapy. The primary endpoint of the study is the proportion of participants who maintain biochemical control on paltusotine vs. placebo. Final study enrollment is 58 participants with topline data expected in the third quarter of 2023.Paltusotine’s Phase 3 PATHFNDR-2 s...