FDA: 30 days to decision on Crinetics hyperinsulinism candidate

  Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today provided an update on its development program for CRN04777, an investigational, oral somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism (HI).

On October 24, 2022, Crinetics submitted an Investigational New Drug application (IND) to the United States Food and Drug Administration (FDA) to initiate the first U.S. clinical study of CRN04777, which is designed to evaluate the compound in a pediatric population (ages 3 months - 12 years). On November 22, 2022, the FDA informed the company via telephonic communication that the proposed Phase 2 clinical study was not yet permitted to proceed. The FDA indicated that it would provide the company with the basis for its decision within 30 days. Crinetics plans to engage with the FDA to understand the additional information or clarifications that may be required before the FDA will allow the study to proceed.

CRN04777 was previously evaluated in 78 adult healthy volunteers in a Phase 1 single- and multiple-ascending dose clinical trial under a Clinical Trial Application in Germany. Results from these studies showed CRN04777 was well tolerated at doses from 30 mg to 120 mg. 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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