Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced that it has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for its proprietary colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021). The drug is under development for the treatment of inoperable tenosynovial giant cell tumor (TGCT).
Pimicotinib, an orally administered small molecule, is highly selective and potent as a CSF-1R antagonist. It is currently being evaluated in a global Phase III clinical trial as a potential therapy for TGCT. This indication has previously earned the drug fast-track status in the US and PRIME status in Europe. In addition to TGCT, a Phase II study of pimicotinib has been accelerated for chronic graft-versus-host disease (cGVHD), and the drug is also being explored in multiple solid tumors and non-solid tumor indications, including amyotrophic lateral sclerosis (ALS).- Flcube.com
