Telitacicept Achieved Primary Endpoint in Phase 3 Clinical Study for Primary Sjögren's Disease with Telitacicept, a Dual BAFF/APRIL Inhibitor
Vor Bio (Nasdaq: VOR) announced that its collaborator RemeGen achieved the primary endpoint in a Phase 3 clinical study for telitacicept in treating primary Sjögren's disease. The study demonstrated that telitacicept significantly improved disease activity as measured by ESSDAI (EULAR Sjögren's syndrome disease activity index) compared to placebo, while maintaining a favorable safety profile.
RemeGen plans to submit a Biologics License Application (BLA) to Chinese regulators, which would make this telitacicept's fourth approved indication in China. The dual BAFF/APRIL inhibitor targets both upstream and downstream autoimmune signaling, potentially offering disease-modifying benefits rather than just symptom management.
Vor Bio (Nasdaq: VOR) ha annunciato che il suo partner RemeGen ha raggiunto l'endpoint primario in uno studio clinico di Fase 3 su telitacicept per il trattamento della sindrome di Sjögren primaria. Lo studio ha dimostrato che telitacicept ha migliorato significativamente l'attività della malattia, misurata mediante ESSDAI (EULAR Sjögren's syndrome disease activity index), rispetto al placebo, mantenendo al contempo un profilo di sicurezza favorevole.
RemeGen prevede di presentare una Biologics License Application (BLA) alle autorità regolatorie cinesi, il che farebbe di telitacicept la sua quarta indicazione approvata in Cina. L'inibitore duale BAFF/APRIL colpisce sia le vie di segnalazione autoimmune a monte che a valle, offrendo potenzialmente benefici in grado di modificare il decorso della malattia anziché limitarsi alla gestione dei sintomi.
Vor Bio (Nasdaq: VOR) anunció que su colaborador RemeGen logró el objetivo primario en un estudio clínico de Fase 3 con telitacicept para el tratamiento del síndrome de Sjögren primario. El estudio mostró que telitacicept mejoró de forma significativa la actividad de la enfermedad, medida por ESSDAI (EULAR Sjögren's syndrome disease activity index), frente a placebo, manteniendo además un perfil de seguridad favorable.
RemeGen planea presentar una Biologics License Application (BLA) a los reguladores chinos, lo que convertiría a telitacicept en su cuarta indicación aprobada en China. El inhibidor dual BAFF/APRIL actúa sobre las señales autoinmunes tanto en fases ascendentes como descendentes, ofreciendo potencialmente beneficios que modifican la enfermedad en lugar de limitarse al control de los síntomas.
Vor Bio (Nasdaq: VOR)는 협력사 RemeGen이 원발성 쇼그렌증후군 치료를 위한 3상 임상시험에서 1차 평가변수를 충족했다고 발표했습니다. 연구 결과 telitacicept는 ESSDAI(EULAR Sjögren's syndrome disease activity index)로 측정한 질환 활동도를 위약에 비해 유의하게 개선했으며, 안전성 프로필도 양호하게 유지되었습니다.
RemeGen은 중국 규제당국에 Biologics License Application (BLA)을 제출할 계획이며, 이는 telitacicept가 중국에서 네 번째로 승인된 적응증이 되는 것을 의미합니다. 이중 BAFF/APRIL 억제제는 상류와 하류의 자가면역 신호를 모두 표적하여 증상 완화에 그치지 않고 질병 경과를 변화시킬 수 있는 이점을 제공할 가능성이 있습니다.
Vor Bio (Nasdaq: VOR) a annoncé que son partenaire RemeGen a atteint le critère principal dans un essai clinique de phase 3 évaluant le telitacicept pour le traitement du syndrome de Sjögren primaire. L'étude a montré que le telitacicept améliorait significativement l'activité de la maladie, mesurée par l'ESSDAI (EULAR Sjögren's syndrome disease activity index), par rapport au placebo, tout en conservant un profil d'innocuité favorable.
RemeGen prévoit de soumettre une Biologics License Application (BLA) aux autorités réglementaires chinoises, ce qui ferait du telitacicept sa quatrième indication approuvée en Chine. L'inhibiteur double BAFF/APRIL cible à la fois les signaux auto-immuns en amont et en aval, offrant potentiellement des bénéfices modificateurs de la maladie plutôt qu'un simple soulagement des symptômes.
Vor Bio (Nasdaq: VOR) gab bekannt, dass sein Partner RemeGen den primären Endpunkt in einer Phase-3-Studie zu Telitacicept bei der Behandlung des primären Sjögren-Syndroms erreicht hat. Die Studie zeigte, dass Telitacicept die Krankheitsaktivität, gemessen am ESSDAI (EULAR Sjögren's syndrome disease activity index), im Vergleich zu Placebo signifikant verbesserte und dabei ein günstiges Sicherheitsprofil beibehielt.
RemeGen plant, eine Biologics License Application (BLA) bei den chinesischen Behörden einzureichen, was Telitacicept zur vierten zugelassenen Indikation in China machen würde. Der duale BAFF/APRIL-Inhibitor zielt sowohl auf upstream- als auch downstream-Autoimmun-Signalwege ab und könnte somit potenziell krankheitsmodifizierende Vorteile bieten, statt nur die Symptome zu behandeln.
- Achieved primary endpoint in Phase 3 trial for primary Sjögren's disease
- Demonstrated favorable safety profile in clinical trials
- Potential to become fourth approved indication for telitacicept in China
- Dual-targeting mechanism offers potential disease-modifying benefits
- Global Phase 3 study timing still under evaluation
- Detailed efficacy data not yet disclosed
Insights
Telitacicept achieved Phase 3 primary endpoint for Sjögren's disease, showing disease-modifying potential with favorable safety profile.
The successful Phase 3 results for telitacicept in primary Sjögren's disease represent a significant clinical advancement in a therapeutic area with historically limited options. The dual-mechanism drug, which inhibits both BAFF and APRIL signaling pathways, achieved its primary endpoint by demonstrating a reduction in the EULAR Sjögren's syndrome disease activity index (ESSDAI) compared to placebo - a comprehensive measurement tool that assesses disease activity across 12 domains.
What makes this particularly notable is telitacicept's unique dual-targeting approach that addresses both upstream and downstream elements of the autoimmune cascade. This mechanism potentially offers disease modification rather than merely symptom management, which would represent a paradigm shift in Sjögren's treatment. The favorable safety profile reported further enhances its clinical potential.
RemeGen's planned Biologics License Application (BLA) submission to Chinese regulatory authorities would make this telitacicept's fourth approved indication in China, demonstrating the drug's versatility across autoimmune conditions. For Vor Bio, this success provides a foundation for potential global expansion beyond their lead myasthenia gravis program, positioning telitacicept as what the company describes as a "pipeline-in-a-product" with broad applicability across multiple autoimmune diseases.
Phase 3 results position telitacicept as potential best-in-disease profile in primary Sjögren's disease
Telitacicept demonstrated a favorable safety profile
Vor evaluating timing of global Phase 3 clinical study in primary Sjögren's disease
Data anticipated to be presented at an upcoming medical conference
CAMBRIDGE, Mass., Aug. 13, 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), achieved the primary endpoint in a Phase 3 clinical study in China evaluating telitacicept in adults with primary Sjögren's disease. Details of the study results are planned to be presented at an upcoming medical conference.
“For decades, patients with primary Sjögren's disease have faced limited treatments options, and telitacicept offers a potential option for these patients which targets the root cause of this devastating autoimmune disease. In an indication where therapeutic progress has been measured in incremental steps, the results from telitacicept suggest the potential for a best-in-disease profile and could set a new benchmark in the field,” said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of the Board. “By targeting both BAFF and APRIL, telitacicept addresses the upstream and downstream autoimmune signaling cascade, offering the possibility of truly modifying the disease instead of simply managing symptoms. This dual-target profile has also shown transformative potential in myasthenia gravis, our lead indication, highlighting telitacicept as a potential pipeline-in-a-product with broad applicability across autoimmune diseases. Sjögren’s represents a significant global expansion opportunity for Vor beyond myasthenia gravis, further extending the reach and impact of our portfolio.”
The Phase 3 clinical study in China achieved the primary endpoint of improving disease activity measured by a reduction in EULAR Sjögren's syndrome disease activity index (ESSDAI), a comprehensive 12-domain index measuring systemic disease activity severity against placebo. Telitacicept demonstrated a favorable safety profile.
RemeGen announced that it plans to submit a Biologics License Application (BLA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for primary Sjögren’s disease, which will become telitacicept’s fourth approved indication in China.
About Vor Bio
Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The Company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and commercialization to address serious autoantibody-driven conditions worldwide. For more information visit www.vorbio.com.
About Telitacicept
Telitacicept is a novel, investigational recombinant fusion protein designed to treat autoimmune diseases by selectively inhibiting BLyS (BAFF) and APRIL - two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. In a Phase 3 clinical trial in generalized myasthenia gravis in China, telitacicept demonstrated a placebo adjusted 4.83-point improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living scale) at 24 weeks, the primary endpoint of the trial.
Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, South America, and Asia-Pacific to support potential approval in the United States, Europe, and Japan.
About Sjögren’s Disease (formerly known as Sjögren’s Syndrome)
Sjögren’s disease is a chronic autoimmune condition in which overactive B cells drive inflammation, damaging moisture-producing glands and, in many cases, other organs. Hallmark symptoms include dry eyes and dry mouth, alongside fatigue, pain, and systemic complications affecting the skin, lungs, kidneys, and nervous system. About one-third of patients develop significant extraglandular involvement, and the disease carries an elevated lymphoma risk, often leading to substantial impairment in daily life.
One of the most common rheumatic autoimmune diseases, Sjögren’s remains underdiagnosed, with roughly half of cases unrecognized and women comprising the vast majority of patients. Despite its prevalence and burden, no systemic disease-modifying therapies exist; current care focuses on symptom management with incomplete relief.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “aim,” “anticipate,” “can,” “continue,” “could,” “design,” “enable,” “expect,” “initiate,” “intend,” “may,” “on-track,” “ongoing,” “plan,” “potential,” “should,” “target,” “update,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio’s statements regarding the potential of telitacicept to have a best-in-disease profile in primary Sjögren’s disease, telitacicept’s safety profile, potential regulatory approval of telitacicept in primary Sjögren’s disease, the timing of presentation of clinical data and submissions to regulatory authorities, the potential of telitacicept to treat indications, Vor Bio’s development and commercialization plans for telitacicept, its ability to change the treatment landscape for patients with autoimmune conditions and other statements that are not historical fact. Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors. The results of the clinical trial described in this press release is based on information reported by RemeGen; Vor Bio has not independently verified this data. These and other risks are described in greater detail under the caption “Risk Factors” included in Vor Bio’s most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law.
Media & Investor Contacts: Carl Mauch cmauch@vorbio.com Sarah Spencer investors@vorbio.com
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