Business
Cogent Biosciences Provides Corporate Updates and Reports Second Quarter 2021 Financial Results
Initiated Phase 2 open-label clinical study (APEX) for bezuclastinib (CGT9486) in patients with Advanced Systemic Mastocytosis (AdvSM) SUMMIT study for
About this update from Cogent Biosciences, Inc.
[{"type":"text","content":"Initiated Phase 2 open-label clinical study (APEX) for bezuclastinib (CGT9486) in patients with Advanced Systemic Mastocytosis (AdvSM)\n SUMMIT study for patients with Non-Advanced Systemic Mastocytosis (NonAdvSM) on track to start 2H 2021 following recent positive interactions with FDA\n Formed Cogent Scientific Advisory Board, including several world-class experts in targeted therapy\n Ended Q2 2021 with $218.1 million in cash, sufficient to fund operations into 2024\n\n\n CAMBRIDGE, Mass. and BOULDER, Colo., Aug. 16, 2021 /PRNewswire/ -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced financial results for the second quarter ended June 30, 2021 and provided corporate updates.\n\n \n \n \n \n \n \n\n \n\"People fighting advanced systemic mastocytosis live every day in need of additional treatment options. We initiated the Phase 2 APEX clinical study for our lead program bezuclastinib, designed to specifically target the underlying genetic cause of advanced systemic mastocytosis with the goal of providing new therapeutic options for patients,\" said Andrew Robbins, President and CEO of Cogent Biosciences. \"In addition, we look forward to advancing bezuclastinib into two new clinical studies by the end of 2021, including the SUMMIT study for patients with non-advanced systemic mastocytosis, while actively progressing novel discovery programs with the recently formed Cogent Research Team.\" \nRecent Program and Corporate Highlights\nAPEX Study in AdvSM Patients Initiated Cogent initiated APEX, a Phase 2 clinical study of bezuclastinib in patients with AdvSM. APEX is an open-label, global, multicenter study that will evaluate the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. Learn more about the APEX study at www.cogentclinicaltrials.com Cogent expects to report preliminary clinical data from the APEX study in the first half of 2022, including levels of serum tryptase, a validated biomarker of mast cell activity.SUMMIT Study of bezuclastinib in NonAdvSM Patients on track to start 2H 2021 Following recent positive interactions with FDA, Cogent is on track to initiate SUMMIT, a randomized, double-blind placebo-controlled Phase 2 clinical study of bezuclastinib in patients with NonAdvSM. FD...