Vor Bio’s big bet on RemeGen’s autoimmune asset telitacicept appears well placed after the drug—already approved across three conditions overseas—delivered a late-stage win in a Sjögren's syndrome trial in China.

The China-based phase 3 trial of telitacicept in primary Sjögren's syndrome (pSS) met its primary endpoint, which focused on patients’ change from baseline at week 24 on a common measure of disease activity known as ESSDAI, RemeGen said Wednesday.

The company did not provide a detailed breakdown of the data but noted that the results showed telitacicept “sustainably and effectively” improved patients’ symptoms, with a "favorable" safety profile to match.

RemeGen will use the win to file for approval with China’s Center for Drug Evaluation, and the company says it plans to present the detailed pSS results at upcoming international medical conferences.

Sjögren's syndrome is estimated to affect around 4 million to 10 million people in China, according to RemeGen. It’s estimated that around 4 million people live with Sjögren's in the U.S.

The condition is a chronic inflammatory autoimmune disease that most frequently leads to dry eyes and dry mouth, though it can cause other debilitating symptoms throughout the body, too. Sjögren's can occur alone but is often accompanied by other immune system disorders like rheumatoid arthritis and lupus.

Enter telitacicept, which works by targeting two cell-signaling molecules for B-lymphocyte development: B lymphocyte stimulator (BlyS) and A proliferation-inducing ligand (APRIL). The protein’s mode of action has informed RemeGen’s thesis that the drug could be used to treat a host of autoimmune diseases driven by B-cell-mediated responses, including Sjögren's.

That line of thinking has already paid off handily for RemeGen in China, where telitacicept is approved in three autoimmune indications: Systemic lupus erythematosus (SLE), rheumatoid arthritis and generalized myasthenia gravis (gMG).

Hoping to get in on the action, in late June, beleaguered Vor Bio paid $45 million upfront to acquire ex-China rights to telitacicept. The deal also includes an initial payment of $80 million in warrants that grant a RemeGen subsidiary roughly a 23% stake in Vor. Long-term, potential clinical and commercial milestones could earn RemeGen up to $4.1 billion from the deal.

Aside from the fast track tag from the FDA, telitacicept is also cleared for a phase 3 trial in primary Sjögren's in the U.S., RemeGen said Wednesday.

The licensing deal marked a major reversal for Vor, which had said in May that it was winding down its existing clinical and manufacturing operations and eliminating 95% of its workforce. Vor had been developing two lead cell therapy assets in acute myeloid leukemia and cited a “challenging fundraising environment” as the rationale behind its deep restructuring.

While the late-stage trial win is no doubt good news for RemeGen, the Sjögren's community had reason to celebrate earlier this week after Novartis reported that its dual-mechanism, B-cell-depleting antibody ianalumab prevailed in two phase 3 studies in the autoimmune disease.

Novartis claimed the wins marked the “first ever global phase 3 trials to demonstrate statistically significant reduction in disease activity for Sjögren's disease.” The Swiss pharma said it will use the results to inform approval applications with global regulators.