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Crinetics Pharmaceuticals Confirms Completion for Half of the Enrolled Patients in the Ongoing Phase 2 ACROBAT Edge Clinical Trial for Paltusotine
28 patients have completed the open-label Edge trial measuring IGF-1 levels after 13 weeks of treatment when patients with acromegaly were switched to once
About this update from Crinetics Pharmaceuticals, Inc.
[{"type":"text","content":"28 patients have completed the open-label Edge trial measuring IGF-1 levels after 13 weeks of treatment when patients with acromegaly were switched to once daily oral paltusotine from commercially available depot injections of the peptide somatostatin receptor ligands (SRLs)\n Recruitment for the Edge and Evolve trials has been completed with 47 and 13 patients, respectively, and topline data is planned for the fourth quarter of 2020 Management expects to use the results for the two trials to support the initiation of Phase 3 clinical development for paltusotine in the first half of 2021 SAN DIEGO, June 11, 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 over 50% of the patients enrolled in the ACROBAT Edge Phase 2 clinical trial have completed the study. So far, 28 of the 47 patients enrolled have completed the study, which is investigating the effects of once daily oral paltusotine on IGF-1 levels after switching patients from injectable depot therapy. “The completion of the trial by these 28 patients is a major milestone for our clinical program at Crinetics. We are extremely grateful for the dedication of our patients and staff at clinical trial sites for keeping us on track in the face of the COVID-19 pandemic,” said Alan Krasner, M.D., Chief Medical Officer of Crinetics. “As we previously stated, we expect to announce topline results in the fourth quarter of this year. These data together with interactions with the regulatory agencies will guide finalization of our Phase 3 clinical plan which is anticipated to begin in the first half of 2021,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. Based on the results of the previously announced interim analysis, Crinetics believes that the data from Edge is supportive of moving forward into Phase 3. Enrollment in the ACROBAT Evolve study was discontinued at the same time that enrollment in Edge was completed. Patients already enrolled in Evolve have continued in the study. Topline data from the 47 patients in Edge, 25 of which entered the trial on octreotide LAR or lanreotide depot monotherapy (group 1), and the 13 patients i...