Oral lupus drug meets Phase 2 goal; Vialine moves into Phase 3

An oral lupus drug candidate from U.S. biotech company Vialine Medicines met its goal in a Phase 2 trial, paving the way for full-scale Phase 3 development.

According to U.S. biotech publication Fierce Biotech on the 9th local time, Vialine Medicines met the primary endpoint in a Phase 2 trial of afimetoran in patients with systemic lupus erythematosus (SLE), an autoimmune disease.

Afimetoran is an oral small-molecule drug that inhibits toll-like receptors 7 and 8 (TLR7/8). After daily oral administration for 48 weeks, the SRI-4 response rate was higher in the afimetoran group than in the placebo group.

All three doses showed significant improvement versus placebo in the primary endpoint, the SRI-4 response rate. The company said results for secondary endpoints were consistent with those for SRI-4. However, it did not disclose specific figures beyond saying that the p value for the primary endpoint was less than 0.001.

Safety and tolerability were generally consistent with those seen in the earlier Phase 1 trial. Before transferring the compound, Bristol Myers Squibb (BMS) conducted a first-in-human safety study and a Phase 1b trial in cutaneous lupus erythematosus (CLE), and found a favorable safety profile.

Vialine plans to advance afimetoran into Phase 3 development for both SLE and CLE, with the aim of making it a potential best-in-class oral treatment for both forms of lupus.

Germany's Merck entered Phase 3 trials this year in SLE and CLE with its oral TLR7/8 inhibitor enpatoran, securing a first-in-class position.

Research into lupus treatments targeting TLR7 and TLR8 has continued for years. Scientists reported in 2018 that TLR7 is associated with SLE, and four years later, a study found that a gain-of-function genetic variant in TLR7 causes lupus.

Development of lupus treatments had long been stagnant. After GlaxoSmithKline (GSK) opened the way with Benlysta in 2011, approvals continued to come slowly. AstraZeneca received approval for Saphnelo in 2021 and added a subcutaneous formulation this year. Roche's Gazyva is under review by the U.S. Food and Drug Administration (FDA) for an SLE indication.

With lupus considered a potential blockbuster market, afimetoran, now ready for Phase 3, is expected to attract interest from multiple pharmaceutical companies with autoimmune disease portfolios. Vialine's leadership, however, has said it prefers to develop the drug in-house.

Vialine CEO Sakib Islam recently told Fierce Biotech, "We have experience taking a drug through regulators and securing approval through pricing," and said the company intends to do it again.

Vialine emerged from stealth in April with $300 million (about 402 billion won) and five assets from BMS. In June, it raised an additional $126 million (about 168.8 billion won) in a Series A financing.