EMA PRIME designation for Modis' MT1621 for TK2 deficiency

California, USA-based Modis Therapeutics announced today that the European Medicines Agency has granted PRIME (PRIority MEdicines) designation to MT1621, Modis' investigational treatment for patients with thymidine kinase 2 deficiency (TK2d).

The PRIME designation is awarded by the EMA to promising medicines that target an unmet medical need. Since the program was launched in March 2016, the EMA has granted PRIME designation to only 36 medicines (21% of 177 requests). Modis’ application was supported by data from initial clinical studies in TK2d patients, some of which was presented by Dr Michio Hirano at the International World Muscle Society (WMS) Congress last month.

"We are pleased that MT1621 has been granted PRIME designation by the EMA," said Joshua Grass, chief executive of Modis Therapeutics. "We believe this designation from a major health authority provides validation of our clinical data and therapeutic approach and recognition that TK2 deficiency represents a significant unmet medical need. We look forward to collaborating with the EMA to accelerate development of this important therapy for patients with TK2 deficiency," he added.