Crinetics Pharmaceuticals Initiates Phase 1 Study of CRN01941 for the Treatment of Neuroendocrine Tumors
“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
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.
About Neuroendocrine Tumors
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 10-20% 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 five-year survival probability of ranging from 30-70%. NETs are present in approximately 171,000 adults in
Crinetics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. Such forward-looking statements include but are not limited to the number of subjects the company anticipates will participate in the Phase 1 clinical trial for CRN01941, and plans to advance other pipeline programs. The inclusion of forward-looking statements should not be regarded as a representation by Crinetics that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Crinetics’ business, including, without limitation: potential delays in the commencement, enrollment, and completion of clinical trials; the company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics’ clinical trials and preclinical studies for its product candidates; regulatory developments in the United States, European Union and other foreign countries; unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval, and/or commercialization, or may result in recalls or product liability claims; Crinetics’ ability to obtain and maintain intellectual property protection for its product candidates; and other risks described under the heading “Risk Factors” in the company’s filings with the Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Crinetics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Chief Financial Officer
Source: Crinetics Pharmaceuticals, Inc.