Business
Crinetics Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update
Phase 3 PATHFNDR-1 Study Topline Data expected in September 2023 Enrollment Completed in Phase 3 PATHFNDR-2 Study with Topline Data Expected in 1Q 2024
About this update from Crinetics Pharmaceuticals, Inc.
[{"type":"text","content":"Phase 3 PATHFNDR-1 Study Topline Data expected in September 2023 Enrollment Completed in Phase 3 PATHFNDR-2 Study with Topline Data Expected in 1Q 2024 CRN04777 Development Suspended Company Hosting KOL Webinar on Acromegaly Treatment Landscape Today at 12:00 pm ET SAN DIEGO, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the second quarter ended June 30, 2023. “The PATHFNDR program for acromegaly continues to progress as expected. Topline results from our Phase 3 PATHFNDR-1 study are expected in September and should provide insight into paltusotine’s potential as an alternative to standard-of-care somatostatin receptor ligand depot injections. Enrollment in our Phase 3 PATHFNDR-2 study is also now complete and we anticipate topline results in the first quarter of 2024,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “Unfortunately, we also suffered a setback with our CRN04777 program and made the difficult decision to wind down its development. We know that infants and children living with congenital hyperinsulinism are in desperate need of better treatment options and our hearts go out to them and their families. However, our recently evolved understanding of the nonclinical profile of CRN04777 suggests that it no longer meets the high standards to which we hold all drug candidates in our pipeline.” Second Quarter 2023 and Recent Highlights: Topline data from paltusotine’s Phase 3 PATHFNDR-1 study expected in September 2023. PATHFNDR-1 is a placebo-controlled Phase 3 clinical study of oral paltusotine in participants with acromegaly switching from standard-of-care peptide depots. The study enrolled 58 participants with acromegaly whose average IGF-1 levels during screening were within the normal range (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 whose average IGF-1 levels at weeks 34 and 36 are within the normal range after switching to paltusotine compared to placebo. Completed enrollment in paltusotine’s Phase 3 PATHFNDR-2 study. PATHFNDR-2 is a placebo-controlled Phase 3 clinical study of oral paltusotine in participants with acromegaly who are treatment-naïve or not currently receiving medical therapy. The study comp...