Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the completion of subject enrollment and dosing in its ABSK021-301 study, a pivotal Phase III trial evaluating the efficacy and safety of its investigational drug ABSK021 (pimicotinib) in treating tendon sheath giant cell tumor (TGCT). This marks the first global Phase III study for TGCT conducted concurrently in China, the United States, Canada, and Europe, highlighting Abbisko’s commitment to addressing unmet medical needs on a global scale.
The randomized, double-blinded, placebo-controlled, multi-center trial has successfully enrolled 94 subjects across more than 30 centers worldwide, surpassing the initial target of 90 cases, with over 50% of participants hailing from Europe or the US. Pimicotinib, a highly potent and selective small-molecule inhibitor of CSF-1R, has shown promise in regulating macrophage function by blocking the CSF1/CSF-1R signaling pathway, which plays a crucial role in various macrophage-related diseases.
In recognition of its potential, pimicotinib has received breakthrough therapy designations (BTDs) from China’s Center for Drug Evaluation (CDE), the US FDA, and the European Medicine Agency (EMA) in July 2022, January 2023, and June 2023, respectively. Additionally, the drug candidate has been cleared for Phase II studies in chronic graft-versus-host disease (cGVHD) and advanced pancreatic cancer, further expanding its potential therapeutic applications.
Merck KGaA secured the rights to commercialize pimicotinib in Greater China and an option for global development in a deal announced in December last year, underscoring the drug’s global potential and Abbisko’s strategic partnerships in advancing innovative therapies.- Flcube.com
