Crinetics Pharmaceuticals, Inc., 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 the dosing of the first patients in the ACROBAT EVOLVE and EDGE trials for CRN00808 in patients with acromegaly. EVOLVE is a double-blind, placebo-controlled, randomized withdrawal study designed to evaluate the safety, efficacy, and pharmacokinetics of CRN00808, an oral selective nonpeptide somatostatin receptor type 2 biased agonist, in patients with acromegaly that are responders to octreotide LAR or lanreotide depot monotherapy. EDGE is an open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of CRN00808 in patients with acromegaly whose disease is inadequately controlled by octreotide LAR or lanreotide depot alone.
"The first patients receiving CRN00808 in these trials marks another important milestone in advancing this novel drug candidate for the treatment of acromegaly," said Alan Krasner, M.D., Chief Medical Officer of Crinetics. "Previously, our Phase 1 trial evaluating once daily oral administration of CRN00808 demonstrated potent suppression of the growth hormone axis in healthy volunteers with a tolerability and adverse event profile consistent with currently approved injected somatostatin agonists. The EVOLVE and EDGE studies are designed to provide important clinical data in a broad cross-section of patients with acromegaly."
ACROBAT EVOLVE is designed to evaluate efficacy of CRN00808 in adult patients aged 18-70, with a confirmed diagnosis of acromegaly who are receiving controlled stable doses of octreotide LAR or lanreotide depot. Patients will switch from their prior injectable therapy to CRN00808 capsules, which will be taken once daily by mouth. After nine weeks, approximately 36 patients will be randomized 1:1 to continue receiving CRN00808 capsules or placebo for up to four weeks. The primary endpoint will be the proportion of patients who meet responder criteria, which is defined as the mean of two consecutive insulin-like growth factor 1 (IGF-1) measurements ≤ Upper Limit of Normal (ULN) after 13 weeks. Secondary endpoints include the proportion of patients who achieve serum growth hormone (GH) < 5.0 ng/mL after 13 weeks, change in IGF-1 levels from Week 10 to Week 13, change in GH levels from Week 8 to Week 13, and change in symptoms of acromegaly from Week 10 to Week 13.
ACROBAT EDGE is designed to evaluate efficacy of CRN00808 in approximately 45 adult patients aged 18-70, with a confirmed diagnosis of acromegaly who do not adequately respond to octreotide LAR or lanreotide depot monotherapy, or patients who require second line therapies such as dopamine agonists, pasireotide, or pegvisomant. Participants will switch from their prior injectable therapy to CRN00808 capsules, taken once daily by mouth, for up to 13 weeks. The primary endpoint will be the change from baseline (mean of screening values) in IGF-1 level after 13 weeks. Secondary endpoints include the proportion of patients with the mean of their last two consecutive IGF-1 measurements ≤ ULN after 13 weeks, the proportion of patients with the mean of their last two consecutive IGF-1 measurements ≤ 1.5×ULN after 13 weeks, and the proportion of patients who achieve serum GH < 5.0 ng/mL after 13 weeks.
"In designing CRN00808, we listened to the acromegaly patient community, as well as the physicians and nurses who care for them," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Our team worked to create the drug candidate with the characteristics that they asked for and deserve. We are excited to work with patients and clinical teams across the U.S. and EU to evaluate CRN00808 in the ACROBAT trials."
About Crinetics’ CRN00808 Acromegaly Program
Crinetics’ Phase 2 program for CRN00808 in acromegaly comprises two separate trials: ACROBAT EVOLVE and ACROBAT EDGE. These studies are being conducted simultaneously in the same centers across the United States and European Union. EVOLVE is a study designed to evaluate CRN00808 versus placebo in patients whose disease is controlled by injected somatostatin analog monotherapy. The EDGE study is designed to explore the effect of CRN00808 in patients whose disease is inadequately...
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