Vor Bio Highlights Telitacicept's Statistically Significant Efficacy in Phase 3 Primary Sjögren’s Disease Trial
Robust Phase 3 Results Show Clinically Meaningful Benefits for Patients
Vor Bio and its collaborator RemeGen have reported pivotal 48-week Phase 3 results showing that telitacicept delivered substantial improvements in disease activity and patient quality of life for primary Sjögren’s disease—a chronic autoimmune disorder currently lacking effective disease-modifying therapies. The data, shared in a late-breaking session at the American College of Rheumatology (ACR) Convergence 2025, highlight telitacicept's ability to outperform placebo across all primary and secondary endpoints.
Clinically Significant Improvement Seen in the Majority of Treated Patients
The study enrolled 381 adults with active, anti-SSA-positive primary Sjögren’s disease. Participants received weekly injections of either telitacicept 160mg, 80mg, or placebo, alongside standard therapy. After 24 weeks, 71.8% of those treated with telitacicept 160mg achieved at least a 3-point reduction on the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI)—the primary endpoint—versus only 19.3% on placebo. These improvements held at week 48, rising slightly to 73.0% for telitacicept 160mg.
Data Snapshot: Sustained, Dose-Dependent Benefits on Disease and Symptoms
| Measure | Telitacicept 160mg | Telitacicept 80mg | Placebo |
|---|---|---|---|
| Mean Change in ESSDAI (week 24) | -4.40 | -3.00 | -0.60 |
| Mean Change in ESSDAI (week 48) | -4.60 | -3.20 | -0.40 |
| =3-point ESSDAI Improvement (week 24) | 71.80% | 47.10% | 19.30% |
| =3-point ESSDAI Improvement (week 48) | 73.00% | 49.10% | 16.50% |
| Low Disease Activity (ESSDAI <5) (week 48) | 55.00% | 32.70% | 12.20% |
| Mean Change in ESSPRI (week 48) | -2.56 | -1.74 | -0.41 |
| =1-point or =15% ESSPRI Reduction (week 48) | 89.10% | 75.40% | 33.30% |
These results signal a consistent, dose-dependent improvement not just in systemic disease activity, but also in patient-reported symptoms including fatigue and pain. Notably, 89.1% of patients on telitacicept 160mg achieved a meaningful reduction in symptom burden (ESSPRI) by week 48, compared with 33.3% on placebo.
Durable Response and Favorable Safety Support Telitacicept’s Best-in-Disease Potential
Safety data across the 48 weeks remained encouraging: adverse events were largely mild to moderate and the overall profile matched placebo and prior telitacicept studies. No new safety signals emerged. These outcomes underscore the potential for telitacicept to address both disease activity and daily function without added risk.
Unmet Need Remains Large—Vor Bio Eyes Global Expansion
Sjögren’s disease impacts millions globally, with the vast majority of sufferers being women and many cases undiagnosed. Current treatments focus only on managing symptoms—often with incomplete relief. Telitacicept’s targeted, dual-BAFF/APRIL mechanism represents a first-in-class strategy aimed at root autoimmune pathology, potentially offering hope where none previously existed.
Vor Bio has stated it is evaluating the timeline for a global Phase 3 trial in primary Sjögren’s disease, a step that could accelerate worldwide access for this underserved patient community. These new findings reinforce telitacicept’s profile as a promising therapy that may fill a long-standing therapeutic void in autoimmune medicine.
Key Takeaway
Vor Bio’s announcement marks a major development for patients with primary Sjögren’s disease. Clinically and statistically significant Phase 3 trial data suggest telitacicept could emerge as a transformative treatment, addressing both root disease mechanisms and real-world symptoms with sustained safety and efficacy. As global studies advance, investors and clinicians alike may want to follow future updates closely for what could be a paradigm shift in autoimmune care.
Contact Information:
If you have feedback or concerns about the content, please feel free to reach out to us via email at support@marketchameleon.com.
About the Publisher - Marketchameleon.com:
Marketchameleon is a comprehensive financial research and analysis website specializing in stock and options markets. We leverage extensive data, models, and analytics to provide valuable insights into these markets. Our primary goal is to assist traders in identifying potential market developments and assessing potential risks and rewards.
NOTE: Stock and option trading involves risk that may not be suitable for all investors. Examples contained within this report are simulated and may have limitations. Average returns and occurrences are calculated from snapshots of market mid-point prices and were not actually executed, so they do not reflect actual trades, fees, or execution costs. This report is for informational purposes only, and is not intended to be a recommendation to buy or sell any security. Neither Market Chameleon nor any other party makes warranties regarding results from its usage. Past performance does not guarantee future results. Please consult a financial advisor before executing any trades. You can read more about option risks and characteristics at theocc.com.
The information is provided for informational purposes only and should not be construed as investment advice. All stock price information is provided and transmitted as received from independent third-party data sources. The Information should only be used as a starting point for doing additional independent research in order to allow you to form your own opinion regarding investments and trading strategies. The Company does not guarantee the accuracy, completeness or timeliness of the Information.
Disclosure: This article was generated with the assistance of AI