Telitacicept Achieved Primary Endpoint in Phase 3 Clinical Study for IgA Nephropathy
Vor Bio (Nasdaq: VOR) announced that its collaborator RemeGen achieved the primary endpoint in Stage A of a Phase 3 clinical study for telitacicept in treating IgA nephropathy (IgAN). The multicenter, randomized, double-blind, placebo-controlled trial enrolled 318 adult IgAN patients and demonstrated a significant 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared to placebo (p<0.0001).
The drug showed a favorable safety profile and demonstrated consistent disease-modifying activity across multiple autoimmune conditions. RemeGen plans to submit a Biologics License Application (BLA) to Chinese regulators, which if approved, would mark telitacicept's fifth approved indication in China.
Vor Bio (Nasdaq: VOR) ha annunciato che la sua partner RemeGen ha raggiunto l'endpoint primario nella Fase A di uno studio clinico di Fase 3 su telitacicept per il trattamento della nefrite da IgA (IgAN). Lo studio multicentrico, randomizzato, in doppio cieco e controllato con placebo ha arruolato 318 pazienti adulti con IgAN e ha mostrato una riduzione significativa del 55% del rapporto proteine/creatinina nelle urine nelle 24 ore (UPCR) a 39 settimane rispetto al placebo (p<0,0001).
Il farmaco ha presentato un profilo di sicurezza favorevole e ha evidenziato un'attivit脿 modificante la malattia coerente in diverse patologie autoimmuni. RemeGen prevede di presentare una Biologics License Application (BLA) alle autorit脿 cinesi che, se approvata, segnerebbe la quinta indicazione approvata per telitacicept in Cina.
Vor Bio (Nasdaq: VOR) anunci贸 que su colaborador RemeGen alcanz贸 el criterio de valoraci贸n primario en la Etapa A de un ensayo cl铆nico de Fase 3 de telitacicept para el tratamiento de la nefropat铆a por IgA (IgAN). El ensayo multic茅ntrico, aleatorizado, doble ciego y controlado con placebo incluy贸 a 318 pacientes adultos con IgAN y mostr贸 una reducci贸n significativa del 55% en la ratio prote铆na/creatinina en orina de 24 horas (UPCR) a las 39 semanas frente a placebo (p<0,0001).
El f谩rmaco present贸 un perfil de seguridad favorable y demostr贸 una actividad modificadora de la enfermedad consistente en diversas enfermedades autoinmunes. RemeGen planea presentar una Biologics License Application (BLA) a los reguladores chinos que, si se aprueba, supondr铆a la quinta indicaci贸n aprobada de telitacicept en China.
Vor Bio (Nasdaq: VOR)電� 順戨牓靷� RemeGen鞚� telitacicept毳� 鞚挫毄頃� IgA 鞁犽硲歃�(IgAN) 旃橂鞚� 3靸� 鞛勳儊鞁滍棙 A雼硠鞐愳劀 1彀� 韽夑皜氤�靾橂ゼ 雼劚頄堧嫟瓿� 氚滍憸頄堨姷雼堧嫟. 雼り赴甏�, 氍挫瀾鞙勲鞍鞝�, 鞚挫毵龟瞼, 鞙勳暯雽�臁� 鞁滍棙鞐愲姅 318氇呾潣 靹膘澑 IgAN 頇橃瀽臧� 霌彪霅橃棃鞙茧┌, 39欤� 鞁滌爯鞐� 鞙勳暯 雽�牍� 24鞁滉皠 靻岆硛 雼氨歆� 雽� 韥爤鞎勴嫲雼� 牍勳湪(UPCR)鞚� 55% 鞙犾潣頃橁矊 臧愳唽鞁涤及鞀惦媹雼�(辫&濒迟;0.0001).
頃措嫻 鞎诫鞚� 氚旊瀸歆來暅 鞎堨爠靹� 頂勲韺岇澕鞚� 氤挫榾瓿� 鞐煬 鞛愱皜氅挫棴 歆堩櫂鞐愳劀 鞚缄磤霅� 歆堧硲 氤�順� 須臣毳� 雮橅儉雰堨姷雼堧嫟. RemeGen鞚� 欷戧淡 攴滌牅雼龟淡鞐� Biologics License Application (BLA)鞚� 鞝滌稖頃� 瓿勴殟鞚措┌, 鞀轨澑霅� 瓴届毎 telitacicept鞚� 欷戧淡 雮� 雼れ劘 氩堨Ц 項堦皜 鞝侅潙歃濎澊 霅╇媹雼�.
Vor Bio (Nasdaq: VOR) a annonc茅 que son partenaire RemeGen a atteint le crit猫re principal lors de l'茅tape A d'un essai clinique de Phase 3 de telitacicept pour le traitement de la n茅phropathie 脿 IgA (IgAN). L'essai multicentrique, randomis茅, en double aveugle et contr么l茅 par placebo a inclus 318 patients adultes atteints d'IgAN et a montr茅 une r茅duction significative de 55 % du rapport prot茅ines/cr茅atinine urinaire sur 24 heures (UPCR) 脿 39 semaines par rapport au placebo (p<0,0001).
Le m茅dicament a pr茅sent茅 un profil de s茅curit茅 favorable et a d茅montr茅 une activit茅 modifiant la maladie de mani猫re coh茅rente dans plusieurs affections auto-immunes. RemeGen pr茅voit de soumettre une Biologics License Application (BLA) aux autorit茅s chinoises qui, si elle est approuv茅e, constituerait la cinqui猫me indication approuv茅e de telitacicept en Chine.
Vor Bio (Nasdaq: VOR) gab bekannt, dass sein Partner RemeGen den prim盲ren Endpunkt in Phase A einer Phase-3-Studie zu Telitacicept in der Behandlung der IgA-Nephropathie (IgAN) erreicht hat. Die multizentrische, randomisierte, doppelblinde, placebokontrollierte Studie schloss 318 erwachsene IgAN-Patienten ein und zeigte nach 39 Wochen eine signifikante 55%ige Reduktion des 24-Stunden-Protein/Creatinin-Verh盲ltnisses im Urin (UPCR) im Vergleich zu Placebo (p<0,0001).
Das Medikament wies ein g眉nstiges Sicherheitsprofil auf und zeigte in mehreren Autoimmunerkrankungen eine konsistente krankheitsmodifizierende Wirkung. RemeGen plant die Einreichung einer Biologics License Application (BLA) bei chinesischen Aufsichtsbeh枚rden, die bei Zulassung die f眉nfte Indikation f眉r Telitacicept in China markieren w眉rde.
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Insights
Telitacicept achieved 55% reduction in proteinuria in Phase 3 IgAN trial, reinforcing its multi-indication potential as a possible best-in-class therapy.
Vor Bio has reported a significant clinical milestone through its collaborator RemeGen, with telitacicept hitting the primary endpoint in a Phase 3 study for IgA nephropathy (IgAN). The drug demonstrated a remarkable
The Phase 3 trial was well-designed - multicenter, randomized, double-blind, and placebo-controlled - involving 318 adult IgAN patients who had already received standard therapy. This robust study design strengthens the credibility of the results.
What makes these results especially compelling is that telitacicept appears to be building a consistent efficacy profile across multiple autoimmune conditions. The drug has shown disease-modifying activity in myasthenia gravis and Sj枚gren's disease previously, and now in IgAN. This supports management's characterization of telitacicept as a "pipeline-in-a-product" with potentially broad applications.
From a mechanistic perspective, telitacicept's approach of targeting upstream drivers of IgAN could differentiate it from symptomatic treatments. By interrupting the disease cascade at its source rather than just managing symptoms, the therapy may offer more durable responses and better long-term kidney preservation.
Following these positive results, RemeGen plans to submit a Biologics License Application to Chinese regulators. If approved, IgAN would become telitacicept's fifth approved indication in China, further validating its multi-indication potential and strengthening Vor Bio's position in the autoimmune disease space.
Results reinforce telitacicept鈥檚 potential across multiple autoimmune diseases
Data anticipated to be presented at an upcoming medical conference
CAMBRIDGE, Mass., Aug. 27, 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 Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with IgA nephropathy (IgAN). Details of the study results are planned to be presented at an upcoming medical conference.
鈥淭elitacicept continues to demonstrate consistent, disease-modifying activity across autoimmune conditions, from myasthenia gravis to Sj枚gren鈥檚 disease and now IgA nephropathy,鈥� said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of the Board. 鈥淚n IgAN, where UPCR is a well-established, objective endpoint for regulatory approval, these results underscore the strength of the telitacicept dataset and its comparability to global benchmarks. By directly targeting the upstream drivers of IgAN and stopping the downstream signaling that fuels disease progression, telitacicept has the potential to modify the disease at its core, potentially leading to deeper, more durable responses and long-term kidney preservation for patients. Taken together, these data reinforce our conviction that telitacicept is a pipeline-in-a-product with the potential to deliver a best-in-class profile across multiple autoimmune diseases.鈥�
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial in China that enrolled 318 adult IgAN patients who had received standard therapy. In Stage A of the Phase 3 study, telitacicept achieved the primary endpoint of reducing proteinuria, demonstrating a
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 IgAN, which if approved would become telitacicept鈥檚 fifth 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 .
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 IgA Nephropathy
IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide and a leading cause of chronic kidney disease (CKD) and end-stage renal disease (ESRD). It is characterized by IgA-containing immune complex deposition in the kidney, leading to inflammation, proteinuria, hypertension, and progressive loss of renal function. Up to
The prevailing scientific consensus is that overproduction of galactose-deficient IgA1 (Gd-IgA1) is a central driver of IgAN. BAFF and APRIL, two cytokines critical to B-cell survival and function, promote the production of Gd-IgA1 and its pathogenic antibodies.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words 鈥渁im,鈥� 鈥渁nticipate,鈥� 鈥渃an,鈥� 鈥渃ontinue,鈥� 鈥渃ould,鈥� 鈥渄esign,鈥� 鈥渆nable,鈥� 鈥渆xpect,鈥� 鈥渋nitiate,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渙n-track,鈥� 鈥渙ngoing,鈥� 鈥減lan,鈥� 鈥減otential,鈥� 鈥渟hould,鈥� 鈥渢arget,鈥� 鈥渦pdate,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� 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鈥檚 statements regarding the potential of telitacicept鈥檚 safety profile in IgAN, telitacicept to be a disease-modifying treatment for IgAN and other autoimmune diseases, the potential for telitacicept to lead to deeper, more durable responses in IgAN, the potential for telitacicept to deliver a best-in-class profile across multiple autoimmune disease, potential regulatory approval of telitacicept in IgAN, the timing of presentation of clinical data and submissions to regulatory authorities, the potential of telitacicept to treat indications, Vor Bio鈥檚 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 are 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 鈥淩isk Factors鈥� included in Vor Bio鈥檚 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聽Mauch [email protected] Sarah Spencer [email protected]
FAQ
What were the Phase 3 trial results for Vor Bio's telitacicept in IgA nephropathy?
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