Crinetics Pharmaceuticals Initiates Phase 1 Study of Lead Candidate CRN00808 for Acromegaly
SAN DIEGO – October 26, 2017 – Crinetics Pharmaceuticals, Inc., a rare disease therapeutics company focused on endocrine disorders and endocrine-related cancers, today 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 CRN00808 in healthy volunteers. CRN00808 is a nonpeptide somatostatin agonist designed to be taken orally to free patients from painful injected therapies and the scheduling of frequent clinic visits to receive them.
“The advancement of our first candidate into the clinic marks a major milestone for Crinetics as we strive to fulfill our goal of developing novel small molecule therapeutics for patients with rare endocrine disorders,” said Scott Struthers, Ph.D., Founder and CEO of Crinetics. “CRN00808, a product of our internal discovery efforts, has demonstrated robust efficacy in animal models of acromegaly and has the potential to be a daily, orally-administered treatment for patients suffering from this serious condition.”
“Acromegaly patients need more options than are currently available. We are grateful for the medicines that we currently have, but far too many of us face breakthrough symptoms as the injectable medications wear off between shots,” said Jill Sisco, President of the Acromegaly Community. “I am hopeful that an oral medicine could be a viable solution to improve the quality of life issues faced by many of us that suffer from acromegaly.”
The single-center Phase 1 study of CRN00808 is being conducted in up to 83 healthy male and female subjects and will be conducted in three phases: a single-ascending dose phase, a multiple-ascending dose phase, and a midazolam drug-drug interaction phase. The primary objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of CRN00808, as well as its ability to suppress serum IGF-1 and GHRH-stimulated GH levels. An additional arm of the study will examine the pharmacokinetics of a capsule formulation of CRN00808 taken with and without food.
Acromegaly is a hormonal disorder resulting from the excess secretion of growth hormone (GH), most commonly the result of a benign pituitary tumor. Excessive growth hormone secretion in turn causes excessive secretion of another hormone, insulin-like growth factor I (IGF-I). Symptoms from the pituitary tumor itself can include severe headaches, vision impairment, and impaired pituitary endocrine function. Excess GH and IGF-I secretion can also cause increased bone and soft tissue growth including changes in facial shape, enlarged hands and feet, and a range of cardiovascular, respiratory, endocrine, and metabolic morbidities. If not adequately treated, acromegaly can lead to serious illness and become life-threatening. The prevalence of acromegaly has been estimated at approximately 7.5 to 8.8 cases per 100,000 persons with a total estimated U.S. patient population of 24,000 to 28,000.
CRN00808 is an orally available, nonpeptide, biased agonist of the somatostatin sst2 receptor that has demonstrated robust efficacy in animal models of excess growth hormone secretion. It is the product of Crinetics’ internal drug discovery efforts and is the lead program in Crinetics’ growing pipeline of drug candidates.
About Crinetics Pharmaceuticals
Crinetics Pharmaceuticals discovers and develops novel therapeutics targeting peptide hormone receptors for the treatment of rare endocrine disorders and endocrine-related cancers. Crinetics was founded by a team of scientists with a proven track record of endocrine drug discovery and development to create important new therapeutic options for endocrinologists and their patients. The company is backed by top life sciences investors, 5AM Ventures, Versant Ventures, and Vivo Capital and is headquartered in San Diego.