Abbisko Finishes Enrollment for Global Phase III Pimicotinib Trial in TGCT

Abbisko Therapeutics, a biopharmaceutical company, has successfully completed patient recruitment for its critical Phase III clinical trial, known as MANEUVER (ABSK021-301) STUDY. This trial is aimed at assessing the effectiveness and safety of a drug named pimicotinib for the treatment of tenosynovial giant cell tumor (TGCT). The trial saw an enrollment of 94 patients, surpassing the initial target of 90, and is being executed across over 30 global sites, with a significant participation from Europe and North America.

Pimicotinib is a groundbreaking, orally administered medication that is both highly selective and potent. It is a small molecule inhibitor of CSF-1R, a protein involved in the growth and maintenance of certain tumors. Abbisko Therapeutics is the innovator behind this drug and has received significant regulatory support. The company has been granted the Breakthrough Therapy Designation by both the China NMPA and the U.S. FDA, as well as the PRIME designation from the EMA. Additionally, the U.S. FDA has provided Fast Track Designation and Orphan Drug Designation for TGCT patients who are not candidates for surgery, which is expected to expedite the global development and market availability of pimicotinib.

Abbisko Therapeutics has also entered into a licensing agreement with Merck, granting them exclusive rights to market pimicotinib in China, Hong Kong, Macau, and Taiwan, with an option for global commercial rights.

TGCT is a tumor that can be aggressive and affect various parts of the body, including joints, causing discomfort and reduced mobility, which significantly impacts the quality of life for those affected. Presently, there are limited treatment options available, with no systemic therapies approved in China and Europe, and only one in the U.S., indicating a significant need for new treatments in these regions.

Beyond TGCT, Abbisko is also exploring the use of pimicotinib for other medical conditions. The company has received approval from the China NMPA to initiate Phase II clinical trials for chronic graft-versus-host disease and advanced pancreatic cancer.

The Phase III MANEUVER study is structured in two parts. The first part involves a double-blind approach, where patients are randomly assigned to receive either pimicotinib or a placebo for 24 weeks. Upon completion, eligible patients can proceed to the second part, which is an open-label phase where all participants receive pimicotinib for an additional 24 weeks. The primary goal of the study is to measure the 25-week overall response rate as determined by an independent review committee.