RemeGen's telitacicept helps improve myasthenia gravis severity in phase 2 trial
Anna Altenburger
- RemeGen (OTCPK:REGMF) (OTCPK:REGMY) said its novel fusion protein telitacicept help reduce the severity of symptoms in Chinese patients with myasthenia gravis (MG) in a phase 2 trial.
- MG is an autoimmune neuromuscular disorder mainly characterized by muscle weakness and muscle fatigue.
- In the study, 41 patients were enrolled but 29 were assigned and treated for 24 weeks. In a dosing cycle of once per week, 14 received Telitacicept 160-mg, while 15 were on 240-mg dose. The main goal was change in the Quantitative Myasthenia Gravis (QMG) test score — a tool measuring MG disease severity in the patients.
- The trial showed a mean reduction of 7.7 points in the telitacicept 160mg group and 9.6 points in the telitacicept 240mg group. The company said an improvement of 3 points is clinically significant, and more than 5 points represents significant curative effects.
- RemeGen added that telitacicept can significantly improve the condition of patients and showed good safety in treating MG.
- In October, the U.S. FDA granted orphan drug designation to Telitacicept (RC18) to treat MG.