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Crinetics Pharmaceuticals Reports Positive Interim Results for the ACROBAT Edge Phase 2 Trial of Paltusotine (CRN00808) in Acromegaly Patients and Provides Corporate Update
Data from initial patients who have completed the ongoing open label Edge trial show that IGF-1 levels were maintained after 13 weeks of treatment when
About this update from Crinetics Pharmaceuticals, Inc.
[{"type":"text","content":"Data from initial patients who have completed the ongoing open label Edge trial show that IGF-1 levels were maintained after 13 weeks of treatment when patients were switched to once daily oral paltusotine from commercially available depot injections of the peptide somatostatin receptor ligands, octreotide or lanreotide. ACROBAT Edge recruitment is complete and topline data from all patients in the trial is expected in the fourth quarter of 2020Crinetics plans to advance paltusotine into Phase 3 for patients with acromegaly in the first half of 2021 with to-be-marketed formulation and also into Phase 2 for patients with neuroendocrine tumors who suffer from carcinoid syndromeManagement to host webcast/conference call Tuesday, April 7, 2020 at 8 a.m. EDT / 5 a.m. PDT SAN DIEGO, April 06, 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 reported interim results from the ongoing ACROBAT Edge Phase 2 trial. Results as of a February 23, 2020 data cutoff showed that acromegaly patients switching from injectable depot therapy to once daily oral paltusotine (formerly CRN00808) maintained IGF-1 levels previously achieved with commercially available depot injections of somatostatin receptor ligands (SRLs).\n Interim results from an exploratory analysis of the first 13 patients who entered the Edge trial on octreotide or lanreotide depot monotherapy (group 1) showed that, as of the cutoff date, switching to once daily oral paltusotine maintained patient IGF-1 levels at those achieved with prior depot therapy [mean change from baseline = -0.015 x ULN (95% CI = -0.123, +0.092)]. Ten of the 11(91%) patients in group 1 who completed paltusotine treatment maintained IGF-1 levels within 15% of their respective baseline levels at week 13. No patient required “rescue therapy” with prior injected peptide acromegaly therapy after switching to paltusotine. Of the 12 patients in whom IGF-1 levels were measured two weeks after paltusotine withdrawal, the mean increase of IGF-1 from baseline was 0.74 x ULN ((95% CI = 0.394, 1.083), p10%) were headache, arthralgia, peripheral swelling, back pain and hyperhidrosis. One serious adverse event (headac...