Crinetics Pharmaceuticals Initiates Phase 1 Study for Treatment of Neuroendocrine Tumors

Crinetics Pharmaceuticals, Inc. recently announced the initiation of a Phase 1, double-blind, randomized, placebo-controlled, single- and multiple-dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of CRN01941 in healthy volunteers. CRN01941 is an oral nonpeptide somatostatin receptor subtype 2 (sst2) biased agonist designed for the treatment of neuroendocrine tumors (NETs) that originate from neuroendocrine cells commonly found in the gut, lung, or pancreas.

“Crinetics is dedicated to building a pipeline of novel therapeutics for rare endocrine diseases and endocrine-related tumors. We are excited to advance CRN01941, our second product candidate, into the clinic,” said Alan Krasner, MD, Chief Medical Officer of Crinetics. “CRN01941 has the potential to be an orally-administered treatment for patients struggling with NETs. Although these tumors are typically slow growing, they are also often metastatic resulting in significant morbidity and mortality.”

This Phase 1, double-blind, randomized, placebo-controlled, single-dose and multiple-dose study of CRN01941 will enroll up to 119 healthy male and female subjects. This single-center study will be conducted in 3 parts: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-ascending dose phase (up to 5 cohorts, 9 subjects/cohort), and single dose phase in elderly subjects (1 cohort, 10 subjects). The primary objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of CRN01941. Additional information about the trial can be found on ClinicalTrials.gov using the identifier NCT03936166.

NETs arise from cells of the enteroendocrine system in the gastrointestinal tract (approximately 70% of cases) but can also arise from neuroendocrine cells in the lung (approximately 25% of cases) or, more rarely, the pancreas. In approximately 10% to 20% of cases, these tumors are associated with excess secretion of serotonin resulting in carcinoid syndrome, which is characterized by severe diarrhea and flushing. Patients with well- and moderately differentiated tumors and distant metastases have a 5-year survival probability of ranging from 30% to 70%. NETs are present in approximately 171,000 adults in the US and while still an orphan disease, it is the second most common gastrointestinal malignancy after colon cancer.

Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company’s lead product candidate, CRN00808, is an oral selective nonpeptide somatostatin receptor type 2 biased agonist undergoing two Phase 2 clinical trials for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the US. Crinetics’ second oral product development candidate, CRN01941, has entered the clinic for the treatment of neuroendocrine tumors. The company is also developing oral non-peptide somatostatin agonists for hyperinsulinism, as well as oral nonpeptide ACTH antagonists for the treatment of Cushing’s disease. For more information, visit www.crinetics.com.