Vor Bio's IgA nephropathy drug shows 55% reduction in proteinuria

BOSTON - Vor Bio (NASDAQ:VOR) announced Saturday that telitacicept achieved its primary endpoint in Stage A of a Phase 3 clinical study in China for adults with IgA nephropathy (IgAN), showing a 55% greater reduction in proteinuria compared to placebo after 39 weeks of treatment. The clinical-stage biotech, with a market capitalization of $128.17 million, has seen its stock fall 22.44% over the past week despite this positive news, according to InvestingPro data.

The multicenter, randomized, double-blind study of 318 patients demonstrated that weekly subcutaneous injections of telitacicept (240 mg) reduced 24-hour urine protein-to-creatinine ratio by 58.9% versus 8.8% for placebo. The drug also met all key secondary endpoints, including stabilization of kidney function and higher rates of disease remission.

Telitacicept helped 61% of treated patients achieve a protein-to-creatinine ratio below 0.8 g/g compared to 19.5% in the placebo group. Additionally, 24.5% of patients receiving telitacicept reached levels below 0.3 g/g versus just 0.6% on placebo.

The treatment demonstrated a favorable safety profile with most adverse events being mild or moderate. Serious adverse events were less frequent with telitacicept (2.5%) than with placebo (8.2%).

"These findings demonstrate its potential to deliver disease-modifying effects in IgAN," said Jean-Paul Kress, CEO and Chairman of Vor Bio.

The drug is a recombinant fusion protein designed to inhibit BLyS (BAFF) and APRIL, two cytokines essential to B cell and plasma cell survival. It is already approved in China for systemic lupus erythematosus, rheumatoid arthritis, and generalized myasthenia gravis.

RemeGen Co., Ltd (HKEX:9995, SHA:688331), Vor Bio's collaborator, has submitted a Biologics License Application to Chinese regulators for telitacicept in IgAN. The findings were presented at the American Society of Nephrology's Kidney Week 2025.

The information in this article is based on a press release statement from Vor Bio.

In other recent news, Vor Bio announced the appointment of Jeremy Sokolove, M.D., as its Chief Medical Officer, bringing over 20 years of experience in rheumatology and autoimmune disease research. Additionally, Vor Bio shared promising 48-week extension data from a Phase 3 study of telitacicept in patients with generalized myasthenia gravis, showing significant improvement in patients' conditions. The company also plans to host a webcast to present Phase 3 data for telitacicept in primary Sjögren's disease, featuring experts from both Vor Bio and RemeGen Co.

In related developments, Baird upgraded Vor Biopharma's stock rating from Neutral to Outperform, citing the potential of telitacicept and raising the price target significantly. This upgrade was influenced by the positive outcomes from multiple clinical trials conducted by RemeGen in China. Furthermore, Vor Biopharma's stock saw an increase following the positive results from a Phase 3 study of telitacicept in primary Sjögren's disease, which met its primary and secondary endpoints. These developments highlight significant progress in Vor Bio's clinical efforts and potential market impact.

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