More good news in Sjogren's as RemeGen trial delivers

A second new drug has shown efficacy in a phase 3 Sjögren's syndrome trial in the space of a week, RemeGen's telitacicept, further raising the hopes of patients with the debilitating autoimmune disorder.

Today, the biopharma company revealed that the BLyS/BAFF and APRIL-targeting drug met the primary endpoint in its study, which enrolled patients with Sjögren's in China, its home market.

Sjögren's is a condition that affects millions of people worldwide and causes dryness in mucosal surfaces like the eyes and mouth, as well as organ damage and an increased risk of life-threatening cancers.

There are no targeted treatments yet, and patients are currently managed with artificial tears and saliva substitutes, medications to stimulate tear and saliva production, painkillers, and immunosuppressant drugs if symptoms are severe.

Yantai-based RemeGen said it will now move ahead with filing telitacicept with China's National Medical Products Administration (NMPA), which has already approved the drug as a treatment for generalised myasthenia gravis (gMG), systemic lupus erythematosus (SLE), and rheumatoid arthritis (RA).

Telitacicept has also been advanced into a phase 3 trial in the US, Europe, and South America in gMG, with results due in 2027, but it is not yet in trials outside China for Sjögren's. However, approval has been granted for a phase 3 trial by the US FDA, which has also granted the drug fast-track status for the disorder.

In June, rights to the drug outside China, Hong Kong, Macau, and Taiwan were licensed to US biotech Vor Bio for $125 million upfront.

In the Chinese study, telitacicept achieved a significant improvement from baseline in the ESSDAI score, a standard for measuring Sjögren's syndrome disease activity, at week 24, while showing what RemeGen said was a "favourable" safety profile.

The result has emerged just a couple of days after Novartis reported positive results with its anti-BLyS/BAFF antibody ianalumab in two phase 3 Sjögren's trials, which also showed a significant improvement on the ESSDAI scale. Novartis plans to file for approval of ianalumab on the strength of that data.

Another near-term rival in Sjogren's is Johnson & Johnson's FcRn inhibitor nipocalimab, which started a phase 3 programme last December. Meanwhile, Argenx is also running late-stage studies of its FcRn inhibitor Vyvgart (efgartigimod alfa) in the disorder.

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