Zenas on track to seek obexelimab approval in US, EU for IgG4-RD
Therapy shown in large trial to reduce flares with weekly injections
Written by |
Zenas Biopharma says it’s on track to submit applications this year in the U.S. and the European Union seeking approval of its experimental injection therapy obexelimab for treating immunoglobulin G4-related disease (IgG4-RD).
In fact, the developer noted that it intends to file a biologics license application to the U.S. Food and Drug Administration by the end of June, according to a company press release announcing Zenas’ latest financial results and corporate updates. A marketing authorization application to the European Medicines Agency for EU approval is expected for later this year, the company stated.
“With our balance sheet strengthened by recent financings, Zenas remains focused on preparing for the potential commercialization of obexelimab while continuing to advance our broader pipeline,” said Lonnie Moulder, founder and CEO of Zenas.
Both submissions will be based on positive results from the global Phase 3 INDIGO clinical trial (NCT05662241), which tested obexelimab against a placebo in nearly 200 adults with active IgG4-RD who required treatment with standard glucocorticoids. The data showed that the therapy candidate reduced flares among patients and helped maintain disease control over one year.
Complete trial results will be presented June 4 at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, to be held in London.
“Over the next three quarters, we expect to achieve important clinical and regulatory milestones, including the presentation of INDIGO study results at EULAR [and] the filing and acceptance of our marketing applications for obexelimab for IgG4-RD in the U.S. and Europe,” Moulder said.
Study now testing long-term safety, effectiveness of obexelimab
IgG4-RD is a chronic immune disorder that can cause inflammation and scarring in multiple tissues and organs. B-cells, a type of immune cell, play an important role in driving the abnormal immune activity seen in the disease.
An antibody-based therapy, obexelimab is designed to block B-cell activity without depleting, or destroying, these cells. It binds to CD19 and FCGR2B, two proteins on the surface of B-cells that are involved in the cells’ immune activity, and is designed to be given as a self-administered subcutaneous, or under-the-skin, injection.
Top-line, one-year data from INDIGO confirmed the trial met its main goal, with obexelimab significantly reducing the risk of IgG4-RD flares, by 56%, compared with the placebo.
All four key secondary goals were also met, with the therapy showing superiority at promoting complete disease remission and reducing relapses. Treatment also helped to lower the overall use of rescue therapy. Obexelimab was generally safe and tolerated well, the data showed.
Participants who completed INDIGO’s placebo-controlled part could choose to join the study’s open-label extension part, during which all are treated with obexelimab for up to three years. Those data will inform the therapy’s long-term safety and effectiveness, the developer noted.
Zenas is also testing obexelimab as a treatment for people with other autoimmune diseases linked to abnormal B-cell activity, such as lupus and multiple sclerosis.
