2024 ACoP——和誉医药将展示匹米替尼模型引导的剂量选择研究结果

和誉医药将在此次ACoP大会上展示的报告信息如下:

摘要编号：M-082

标题：综合药代动力学、安全性和有效性信息的模型以引导匹米替尼剂量选择

现场海报展示时间：2024年11月11日

关于匹米替尼

匹米替尼是和誉医药独立自主研发的一款全新口服、高选择性、高活性CSF-1R小分子抑制剂，已获得中美欧三地突破性治疗药物和优先药物认定，以及美国快速通道认定和欧洲孤儿药资格认定，用于治疗不可手术的腱鞘巨细胞瘤。

和誉医药正在开展“一项评估匹米替尼（Pimicotinib, ABSK021）在腱鞘巨细胞瘤患者中有效性和安全性的随机、双盲、安慰剂对照、多中心III期临床研究（方案编号: ABSK021-301）“。

2024 ACoP——Abbisko will present the model-informed dose selection results for Pimicotinib (ABSK021)

On October 17, 2024, Abbisko Therapeutics (HKEX code: 02256) announced that the company will present a model-informed dose selection study of pimicotinib in the treatment of tenosynovial giant cell tumor (TGCT) at the 2024 American Conference on Pharmacometrics (ACoP). The ACoP conference will be held in Phoenix, USA from November 10 to 13.

Abbisko presentation at ACoP 2024: 

Abstract Number: M-082

Title: Integration of pharmacokinetics, safety, and efficacy into model-informed dose selection for pimicotinib

Poster Time: 11 Nov, 2024

About 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 U.S. FDA, as well as the PRIME designation from EMA. Furthermore, the U.S. FDA granted Fast Track Designation (FTD), and Orphan Drug Designation (ODD) granted by EMA, for the treatment of TGCT patients who are not amenable to surgery.

Abbisko is conducting "a randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of pimicotinib (ABSK021) in patients with tenosynovial giant cell tumor (protocol No.: ABSK021-301)."