#USA #San Diego #RemeGen #Myasthenia Gravis #Telitacicept

RemeGen's Groundbreaking Phase 3 Clinical Trial Results for Telitacicept

On April 8, 2025, during the Late-Breaking Science Session at the American Academy of Neurology (AAN) Annual Meeting in San Diego, California, RemeGen Co., Ltd. announced compelling findings from its Phase 3 clinical trial evaluating Telitacicept (RC18, marketed as 泰爱®) for patients with generalized myasthenia gravis (gMG). This study, registered under NCT05737160, is a pivotal moment in the treatment of this debilitating autoimmune disease.

Significant Findings

The trial yielded impressive results: in the Telitacicept 240 mg group, 98.1% of participants experienced a reduction of 3 or more points in their Myasthenia Gravis Activities of Daily Living (MG-ADL) score, while 87% showed a similar reduction of 5 or more points in the Quantitative Myasthenia Gravis (QMG) score by week 24. These results represent the highest recorded MG-ADL response rate for any gMG treatment in Phase 3 studies to date, potentially setting a new standard for patient care.

Telitacicept is a novel fusion protein designed to independently target both BlyS and APRIL, inhibiting the abnormal B cells and plasma cells responsible for the production of pathogenic antibodies. The study, led by Professor Jian Yin from Beijing Hospital, enrolled 114 patients with substantial MG-ADL and QMG scores. The double-blind treatment phase lasted for 24 weeks, followed by an open-label stage, with the reported results stemming solely from the first half of the study.

Clinical Outcomes

The data underscored Telitacicept’s potential in achieving sustained and significant clinical improvements. After just four weeks of treatment, Telitacicept demonstrated marked enhancements in both MG-ADL and QMG scores compared to the placebo group. Specifically:

• - MG-ADL: The change at week 24 was -5.74 for the Telitacicept group versus -0.91 for the placebo group, translating into a staggering 98.1% reduction in MG-ADL scores for Telitacicept participants as opposed to just 12.0% for the placebo.
• - QMG: The change registered was -8.66 for Telitacicept compared to -2.27 for placebo, with 87% of patients in the Telitacicept group achieving a 5-point reduction in QMG scores, illustrating significant reductions in disease severity.

Continued improvement was observed, with scores declining over time, peaking at week 24. Notably, Telitacicept maintained a favorable safety profile, with adverse events occurring at rates comparable to the placebo group.

Expert Insights

Professor Yin emphasized the rapid and significant improvements observed during the trial and noted the mechanism by which Telitacicept effectively limits disease progression and enables reduced steroid reliance as symptoms improve. Dr. Jianmin Fang, CEO of RemeGen, remarked on the meaningful implications of this Phase 3 data, highlighting the substantial unmet medical need in gMG and the potential for Telitacicept to enhance the quality of life for affected patients.

Implications for the Future

Myasthenia gravis is an autoimmune condition characterized by neuromuscular junction transmission disorders, causing fatigue and sporadic symptom fluctuations. With over 1.2 million MG patients globally, including approximately 220,000 in China, the demand for effective treatment options is paramount. The promising data from this trial signifies a breakthrough for Chinese biopharmaceutical innovation in neuroimmunology.

The Biologics License Application (BLA) for Telitacicept has been accepted by the Center for Drug Evaluation (CDE) in China, with an approval anticipated in the upcoming months. Concurrently, RemeGen is advancing a global Phase 3 trial to further substantiate the drug's efficacy and safety across a broader patient demographic, aiming to expand access to this transformative treatment worldwide.

Conclusion

The latest results from RemeGen's trial with Telitacicept could significantly influence the therapeutic landscape of myasthenia gravis. As the medical community awaits further developments, the data stands as a beacon of hope for patients enduring this challenging condition.