Mon. 8 Nov 2021, 8:06am ETBenzinga
In: News, FDA, Events

 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, announced today that new data from ACROBAT Advance, the ongoing open label extension (OLE) trial of paltusotine in patients with acromegaly, will be featured in a poster presentation at the annual Society for Endocrinology BES congress in Edinburgh, Scotland. Patients who completed either of the Phase 2 ACROBAT Edge or Evolve studies including a 4-week washout period were eligible to enroll in Advance.

ACROBAT Edge and Evolve were two separate Phase 2 studies that enrolled a broad cross section of acromegaly patients, including those who were biochemically controlled (defined by IGF-1 ≤1.0x upper limit of normal [ULN]) on an injected somatostatin receptor ligand (SRL), as well as those who were uncontrolled (defined by IGF-1 >1.0x ULN) on treatment regimens that included an SRL. Through August 31, 2021, 84% (41/49) of eligible ACROBAT participants had opted to continue into the Advance OLE.

As of August 31, 2021, 23 of the 41 Advance participants had completed 51 weeks of treatment with only four participants discontinuing from the study. Treatment with paltusotine resulted in median serum insulin-like growth factor-1 (IGF-1) levels that were lower than those observed in the washout (untreated) period in the parent studies and were then stably maintained at levels achieved on prior SRL therapy for up to 51 weeks. This was true for patients with controlled or uncontrolled IGF-1 at baseline while treated with injected SRLs. Results also showed that paltusotine was generally well tolerated.

"It is very encouraging that IGF-1 levels, a clinically recognized biomarker of disease severity and registrational endpoint for acromegaly, have been maintained in Advance participants at levels comparable to those achieved with injected SRLs after almost a year on paltusotine," said Alan Krasner, M.D., chief medical officer of Crinetics. "This is an important observation that we look forward to monitoring as the OLE continues. We deeply appreciate the enthusiasm and engagement of our study subjects and investigative teams around the world that allow us to continue to gather this important long-term safety and efficacy data."

"These promising long-term data further support our thesis that once daily oral paltusotine has the potential to replace injected peptide depots as the standard-of-care for acromegaly," added Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "They also give us added confidence as we advance through our Phase 3 PATHFNDR program, which aims to support the registration of paltusotine for all acromegaly patients who require pharmacotherapy."