Vor Bio's Collaborator, RemeGen, Presents 48-Week Open-Label Extension Data From Phase 3 Study In China Evaluating Telitacicept In Patients With gMG At AANEM Annual Meeting

Author: Benzinga Newsdesk | October 29, 2025 10:03am

Telitacicept delivered consistent quality-of-life improvement across both treatment and placebo crossover arms

100% of patients on telitacicept for 48 weeks achieved ≥2-point Myasthenia Gravis Activities of Daily Living (MG-ADL) improvement, with a mean reduction of -7.5 points

Sustained efficacy and favorable safety extension data support potential global best-in-disease profile in generalized myasthenia gravis (gMG)

BOSTON, Oct. 29, 2025 (GLOBE NEWSWIRE) -- Vor Bio (NASDAQ:VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), presented 48-week open-label extension (OLE) data from its Phase 3 study in China evaluating telitacicept in patients with gMG. The results will be presented in a late-breaking session on October 29 at 10:50am PT at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting.

The Phase 3 trial in China was a randomized, double-blind, placebo-controlled study in patients with AChR-Ab or MuSK-Ab positive gMG. Following the 24-week double-blind period, all patients entered the OLE, with those previously on placebo crossing over to telitacicept 240mg.

The primary endpoint of the study was change from baseline in MG-ADL at 24 weeks, with secondary endpoints including changes in MG-ADL and QMG (Quantitative Myasthenia Gravis) at 12, 24, 36, and 48 weeks, as well as the proportion of patients achieving clinically meaningful improvements (≥3-point decrease in MG-ADL and ≥5-point decrease in QMG) at 24 and 48 weeks. The initial 24-week double-blind treatment stage data were presented at the American Academy of Neurology (AAN) Annual Meeting 2025.

Key Findings from the 48-Week OLE:

• At week 48, patients on telitacicept throughout achieved a -7.5 mean MG-ADL change, while placebo crossover patients achieved -6.3; 96.2% of continuous patients and 90.2% of crossover patients reached ≥3-point improvement.
• At week 48, patients on telitacicept throughout achieved a -9.8 mean QMG change, while placebo crossover patients achieved -9.3; 94.2% of continuous patients and 90.2% of crossover patients reached ≥5-point improvement.
• Telitacicept demonstrated a favorable profile comparable to placebo and consistent with prior studies across other autoimmune indications, including systemic lupus erythematosus, rheumatoid arthritis, primary Sjögren's disease, and IgA nephropathy. No new safety signals were observed. Most adverse events were mild to moderate in severity.
• No injection site reactions were reported during the OLE in patients previously on telitacicept. Injection site reactions in placebo crossover patients were mild, self-resolving, and did not lead to discontinuation.

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