SAN DIEGO, Sept. 04, 2020 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX), 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 that a presentation on the company’s orally administered, small molecule adrenocorticotropic hormone (ACTH) antagonist was selected for a late-breaking session at the virtual European Congress of Endocrinology (eECE) on September 8, 2020. In addition, a poster summarizing results from Phase 1 bioavailability studies of paltusotine (formerly CRN00808), the company’s lead candidate for the treatment of acromegaly, will be available to congress attendees from September 5-9, 2020.
Crinetics is developing an ACTH antagonist for the treatment of diseases associated with excess ACTH such as Cushing’s disease and congenital adrenal hyperplasia (CAH). In the presentation at eECE, Crinetics will present data that one of a lead series of experimental ACTH antagonists reduced corticosterone levels and had a positive effect on adrenal gland size, morphology and function after seven days of repeat dosing in a rat model of ACTH excess. Based on these favorable preclinical in vivo results, Crinetics plans to advance its lead ACTH antagonist into Phase 1 single-ascending dose (SAD) and multiple-ascending dose (MAD) studies in healthy volunteers in late 2020 or early 2021.
“Our drug candidate is on track to be the first ACTH antagonist to enter clinical development for treatment of diseases driven by ACTH excess, including Cushing’s Disease and CAH,” explained Alan Krasner M.D., Chief Medical Officer of Crinetics. “An orally available, potent, nonpeptide drug could have a very meaningful impact in these patients for whom there are limited therapeutic options. We look forward to achieving the next milestone in this program by advancing our lead ACTH antagonist candidate into Phase 1.”
Separately, in a poster presentation at eECE, Crinetics will report results from a Phase 1 study showing that paltusotine provided a favorable mean oral bioavailability of 70%. In addition, no abundant circulating metabolites of paltusotine were identified. Adverse events associated with paltusotine were generally mild and transient and were consistent with those reported with other somatostatin agonists. The results of this study suggest that paltusotine exhibits excellent properties appropriate for chronic once-daily oral treatment of patients with acromegaly.
In April 2020, Crinetics reported interim results from an exploratory analysis of the first 13 patients who entered the ACROBAT Edge Phase 2 trial on octreotide or lanreotide depot monotherapy, which showed that, as of the cutoff date, switching to once daily oral paltusotine maintained IGF-1 levels at those achieved with prior depot therapy. Paltusotine was well tolerated and the adverse events observed were similar to those of other somatostatin agonists. No discontinuations due to drug-related adverse events occurred, and the most common treatment-emergent adverse events (>10%) were headache, arthralgia, peripheral swelling, back pain and hyperhidrosis.
Scott Struthers, Ph.D., founder and Chief Executive Officer of Crinetics, added, “We look forward to reporting topline results from the full ACROBAT dataset in the fourth quarter of this year. At that time, we anticipate having a more complete picture of paltusotine’s pharmacokinetic and clinical profile, including the ability to maintain IGF-1 levels after switching patients from their prior somatostatin receptor ligand depot therapy.”
The poster and oral presentations will be made available on www.crinetics.com following the conclusion of the eECE meeting. Within the virtual ECE environment, they are:
|1)||Effects of Nonpeptide Orally Bioavailable ACTH Antagonists on Adrenal Gland Size and Function in Rats: September 8, 2020 at 13:15 CET. Oral Communications 6 - Late breaking abstracts - Channel 3.|
|2)||Absolute Oral Bioavailability and Absorption, Metabolism, Excretion of [14C]-Labeled Paltusotine (CRN00808), an Orally Bioavailable, Nonpeptide, Selective, Somatostatin Receptor 2 (sst2) Biased Agonist for the Treatment of Acromegaly: September 5, 2020 from 01:00 - 19:05 CET. ePosters: Pituitary and Neuroendocrinology.|
In addition to the above eECE presentations, Crinetics will hold a Hub session titled: New Frontiers in Endocrine Research on September 9th at 08:00 CET during which Dr. Krasner will provide an overview of Crinetics and its pipeline programs. The eECE Hub sessions are open to all healthcare professionals who are registered for eECE 2020. More information may be found on the ECE website: ese-hormones.org/e-ece-2020