Business
Crinetics Pharmaceuticals Announces 2021 Clinical Plans and Reports Fourth Quarter and Full Year 2020 Financial Results
Advancing paltusotine into a Phase 3 program for acromegaly following an FDA meeting Phase 1 clinical proof-of-concept data for CRN04894 and CRN04777 expected
About this update from Crinetics Pharmaceuticals, Inc.
[{"type":"text","content":"Advancing paltusotine into a Phase 3 program for acromegaly following an FDA meeting Phase 1 clinical proof-of-concept data for CRN04894 and CRN04777 expected in 1H 2021 and mid-2021, respectively Management hosting webcast and conference call today at 4:30 p.m. ET SAN DIEGO, March 30, 2021 (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 its 2021 clinical plans and reported financial results for the fourth quarter and year ended December 31, 2020. “We are entering 2021 poised to achieve several key milestones that we believe will consolidate our position as a leader in the design and development of novel small molecule drugs for endocrine diseases,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. “Our positive Phase 2 acromegaly data demonstrate the potential of orally administered paltusotine to replace injectable somatostatin receptor ligand (SRL) depots as the standard-of-care. With input from a recently completed FDA meeting, we have designed the paltusotine Phase 3 program to support its approval for all acromegaly patients who require pharmacotherapy, including both untreated patients and those switching from injected standard of care.” Dr. Struthers continued, “Paltusotine’s success and progress serve as a blueprint for our new therapeutic candidates in endocrinology. We plan to follow a similar path with CRN04777 and CRN04894, both of which recently entered Phase 1 proof-of-concept trials in healthy volunteers. Much like paltusotine’s Phase 1 program, we’ve designed these trials to evaluate safety, drug-like pharmacokinetics, and corresponding pharmacodynamic effects on well-validated hormonal biomarkers for their respective indications. We look forward to reporting results from the Phase 1 trials later this year, and to the continued progression of our clinical and preclinical pipelines.” Full Year 2020 and Recent Highlights Advancing paltusotine to a Phase 3 program for acromegaly following the completion of an FDA meeting. In 1Q 2021, Crinetics met with the U.S. Food and Drug Administration (FDA) to discuss its Phase 2 acromegaly data and plans for a Phase 3 program. Based o...