China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has released data from a Phase II clinical study for its novel fusion protein telitacicept in Chinese patients with myasthenia gravis (MG), showing positive results. The study demonstrated significant improvements in patient conditions and good safety profiles.
Study Design and Results
The multicenter, randomized, open-label Phase II clinical study included adult patients diagnosed with MG who tested positive for acetylcholine receptor antibodies and were receiving standardized medical therapy. With a dosing cycle of once per week for 24 weeks, a total of 41 patients were recruited, with 29 randomly assigned to the trial (14 in the telitacicept 160mg group and 15 in the 240mg group). All participants completed the full duration of the study. The primary efficacy endpoint was the change in the Quantitative Myasthenia Gravis (QMG) test score at week 24 compared to the baseline. The study showed a mean reduction of 7.7 points in the telitacicept 160mg group and 9.6 points in the 240mg group. An improvement of 3 points in the QMG score is considered clinically significant, with more than 5 points representing significant curative effects.
Telitacicept Profile
Telitacicept (RC18) is a proprietary novel fusion protein developed by RemeGen to treat autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). The drug targets two critical cell-signaling molecules for B-lymphocyte development: B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), allowing it to effectively reduce B-cell mediated autoimmune responses implicated in several autoimmune diseases.
Commercialization and Future Development
Telitacicept was commercially launched in China in March 2021 at a price of RMB 2,586 (USD 355) per shot, following conditional marketing approval. It was included on the National Reimbursement Drug List (NRDL) in late 2021. The drug is currently undergoing multiple Phase II/III studies in Sjogren’s syndrome, IgA nephropathy, neuromyelitis optica, multiple sclerosis, and more. It also obtained orphan drug designation (ODD) status in the US for use in MG last month.-Fineline Info & Tech
