Crinetics Pharmaceuticals Reports Positive Top-Line Results from CRN04777 Phase 1 Study Multiple-Ascending Dose Cohorts

• Results Further Support Clinical Proof-of-Concept for CRN04777 by Showing Dose-Dependent Decreases in Fasting and Sulfonylurea-Induced Insulin Secretion
• Management Hosting Webcast and Conference Call to Discuss Findings Today at 4:30 p.m. Eastern Time

Excerpt from the Press Release:

SAN DIEGO – March 30, 2022 – 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 positive top-line results from the multiple-ascending dose (MAD) cohorts of healthy volunteers in a first-in-human Phase 1 clinical study of CRN04777. These results showed a rapid and sustained reduction of insulin secretion, including in a pharmacologic model of congenital hyperinsulinism (HI). CRN04777 is the company’s investigational nonpeptide somatostatin receptor type 5 (SST5) agonist in development as an oral treatment for congenital monogenic and syndromic hyperinsulinism.

“We are very excited to see the strong pharmacologic proof-of-concept data from the MAD cohorts that build upon the trial’s single-ascending dose (SAD) cohorts that were presented at the Congenital HI International Virtual Research Conference in 2021,” explained Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “Consistent with the SAD findings, data from the MAD cohorts showed that CRN04777 inhibited insulin secretion when administered orally once daily over the course of 10 days and eliminated the need for glucose support in a model of hyperinsulinism. We plan to meet with global regulators to discuss the results from our Phase 1 study and plans for advancing the clinical program in HI patients.”

These newly announced data are from 27 healthy volunteers who received once daily oral doses of CRN04777 (30 mg, 60 mg, or 120 mg) or placebo for 10 days with daily sampling to measure levels of fasting plasma glucose and insulin. Results showed CRN04777 treatment led to rapid, sustained and dose-dependent decreases in fasting insulin, which in-turn led to dose-dependent increases in fasting plasma glucose. Pharmacokinetic and exposure profiles were consistent with expectations from the SAD cohorts, with CRN04777 being orally bioavailable with a half-life of approximately 40 hours. Increasing CRN04777 exposures were observed with increasing doses and the study drug was well-tolerated. No serious adverse events (SAEs) were reported and no discontinuations due to adverse events occurred. All adverse events were considered to be mild-to-moderate.

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