AMB-05X Receives EMA PRIME Designation for Treatment of Tenosynovial Giant Cell Tumor
The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.
AmMax Bio announced on Jan. 19, 2023 that the European Medicines Agency (EMA) has granted AMB-05X Priority Medicines (PRIME) designation for the treatment of tenosynovial giant cell tumor (TGCT).
“The positive proof-of-concept data from our prior 12-week Phase II study of AMB-05X in TGCT provided the basis for our PRIME application,” said Larry Hsu, PhD, chief executive officer of AmMax Bio, in a press release. “We appreciate EMA’s decision to award AMB-05X its PRIME designation, which validates the high potential therapeutic value of the program and the significant unmet medical need for patients impacted by TGCT.”
AmMax Bio presented positive Phase II data for the novel local administration of AMB-05X in patients with TGCT at the Connective Tissue Oncology Society meeting in November 2022. The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.
The PRIME designation was launched by EMA to boost support for the development of medicines that target an unmet medical need. EMA will continue to offer early and proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefits and risks through PRIME, according to the company press release.
Source: AmMax
