Abbisko Completed All Patient Enrollment for The Global Phase III TGCT Trial of Its CSF-1R Inhibitor - Pimicotinib
Pimicotinib is a novel, orally available, highly selective, and highly potent small molecule inhibitor of CSF-1R independently discovered and developed by Abbisko Therapeutics. It has obtained the Breakthrough Therapy Designation (BTD) from China NMPA and the
In early
TGCT, a locally aggressive neoplasm which affects synovial joints, mucous sacs, and tendon membranes, resulting in swelling, pain, stiffness, and decreased activity of the affected joints which seriously affect patient's quality of life. Currently, there is no systemic therapy approved in
In addition to TGCT, Abbisko is actively exploring the potential of pimicotinib in treating other indications. The company has obtained approval from China NMPA to conduct Phase II clinical studies in chronic graft-versus-host disease (cGVHD) and advanced pancreatic cancer.
PHASE III MANEUVER (ABSK021-301) STUDY
The Phase III MANEUVER (ABSK021-301) study is a randomized, double-blind, placebo-controlled, multi-centered clinical trial designed to evaluate the safety and efficacy of pimicotinib in patients with TGCT. This study consists of two parts. Part 1 is a double-blinded phase, in which eligible patients were randomized to the pimicotinib treatment group or matching placebo group and receive 50mg QD of pimicotinib or matching placebo (28 days/cycle) until completion of 24 weeks of dosing (Part 1). Patients who complete Part 1 were eligible to continue in Part 2 of the study. Part 2 is an open-label treatment phase, and all patients entering this phase received 50mg QD of open-label pimicotinib until 24 weeks of dosing or withdrawal from the study. Approximately 90 patients were planned to be enrolled, and the primary endpoint is 25-Week ORR by the Blinded Independent Review Committee(IRC).
View original content:https://www.prnewswire.com/news-releases/abbisko-completed-all-patient-enrollment-for-the-global-phase-iii-tgct-trial-of-its-csf-1r-inhibitor--pimicotinib-302111016.html
SOURCE Abbisko