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Hinge Bio Receives FDA Clearance Of IND For HB2198, A First-In-Class B Cell-Depleting Agent Targeting Systemic Lupus Erythematosus And Lupus Nephritis

Hinge Bio gains FDA clearance to begin clinical trials of HB2198 for lupus and lupus nephritis treatment.

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  • Oct 14, 2025

  • Simantini Singh Deo

Hinge Bio Receives FDA Clearance Of IND For HB2198, A First-In-Class B Cell-Depleting Agent Targeting Systemic Lupus Erythematosus And Lupus Nephritis

Hinge Bio, Inc., a privately held biotechnology company focused on discovering and developing innovative multi-specific medicines, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to begin clinical studies of HB2198. The study will evaluate HB2198 in patients with B cell-mediated autoimmune diseases, specifically Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN).


The FDA’s IND clearance marks an important milestone for Hinge Bio as it progresses toward bringing a new class of treatments to patients with serious autoimmune conditions. HB2198 is designed as a novel B cell-depleting therapy intended to deliver safe, durable, and effective immune modulation without the limitations of traditional biologic treatments.


Commenting on the development, Barry Selick, Ph.D., Chief Executive Officer of Hinge Bio, said, “This IND clearance marks a major step forward for Hinge Bio and our mission to create innovative therapies for patients with Lupus and other B cell-mediated diseases where treatment options remain limited. We are eager to advance HB2198 into clinical testing with the goal of providing a safe, off-the-shelf therapy that can offer meaningful benefits to patients.”


Adding further insight, Juha Punnonen, M.D., Ph.D., Chief Development Officer of Hinge Bio, noted, “The IND submission for HB2198 was supported by an extensive preclinical data package that demonstrated strong efficacy and safety results. The findings showed durable depletion of memory B cells—an essential mechanism believed to contribute to an ‘immune reset’ that may offer long-term therapeutic potential across multiple autoimmune disorders.”


With the IND now cleared, Hinge Bio is preparing to initiate clinical trials of HB2198 in patients with SLE and LN, marking the company’s transition from preclinical research to clinical development and reinforcing its commitment to advancing transformative treatments for patients with high unmet medical needs.

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