7 Sep 2023
Carrick Therapeutics Announces U.S. FDA Clearance of IND for CT7439, a First-In-Class Inhibitor of CDK12/13
DUBLIN, Ireland and BOSTON, Sept. 07, 2023 (GLOBE NEWSWIRE) — Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for CT7439, a novel cyclin dependent kinase 12/13 (CDK12/13) inhibitor. The Company plans to initiate the Phase 1 clinical trial in the first half of 2024 and intends to enroll patients with advanced solid tumors, including breast, ovarian and Ewing’s Sarcoma.
“FDA clearance of our IND application for CT7439, Carrick’s second therapeutic candidate, further strengthens our oncology pipeline and will allow us to evaluate how our promising preclinical data translate into clinical benefits in patients with solid tumors,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics.
The Phase 1 clinical trial is a modular design, beginning with a dose escalation for the initial administration of CT7439 to patients. The initial clinical evaluation will be focused on safety and pharmacokinetics, with an opportunity for early Proof of Principle using a blood based pharmacodynamic assay of the homologous recombination repair (HRR) pathway.