HI-Bio reveals data for immunology program behind Biogen acquisition

Biogen recently acquired Human Immunology Biosciences (HI-Bio) along with its promising immunology asset, felzartamab, for a substantial $1.15 billion upfront payment. This acquisition comes on the heels of new promising mid-stage clinical data supporting the use of felzartamab, an anti-CD38 antibody, in treating IgA nephropathy (IgAN). The findings were unveiled at the European Renal Association annual meeting and highlight significant long-term benefits from felzartamab treatment.

Promising Clinical Trial Results

The Phase II IGNAZ trial evaluated felzartamab's efficacy in 54 patients diagnosed with IgAN. Participants were assigned to receive either two, five, or nine doses of 16 mg/kg intravenous felzartamab over a period of 24 weeks or a placebo. The key outcome from this study was a noteworthy reduction in proteinuria levels for patients on the nine-dose regimen. Specifically, these patients experienced an average reduction of approximately 50% in their urine protein creatinine ratio (UPCR) by the 24th month. This group also showed stabilization in kidney function, as indicated by consistent estimated glomerular filtration rate (eGFR) levels, whereas the placebo group saw a rapid decline in eGFR.

Lasting Impact and Safety Profile

One of the standout features of this study is the lasting impact of felzartamab even 18 months post-treatment. Jürgen Floege, one of the study's investigators, noted that such a prolonged treatment effect marks a significant shift from traditional plasma- or B-cell-modulating agents that necessitate ongoing dosing. He highlighted the potential of felzartamab to preserve kidney function without the continuous need for immunosuppression.

As for safety, felzartamab was generally well-tolerated among trial participants. Most adverse events (AEs) were mild in nature. However, two serious AEs were noted, both involving infusion-related tendon ruptures.

Broader Implications and Future Plans

The interim results from the IGNAZ trial contribute to a growing body of evidence pointing to felzartamab’s potential in treating various immune-mediated diseases. Besides IgAN, Phase II trials have also been successfully completed for felzartamab in primary membranous nephropathy and antibody-mediated rejection in kidney transplant recipients.

Looking ahead, HI-Bio intends to proceed with Phase III trials for felzartamab across all three indications. The objective is to confirm the efficacy and safety of this anti-CD38 antibody on a larger scale, potentially paving the way for broader clinical use.

Conclusion

The acquisition of HI-Bio and the promising data from the IGNAZ trial underscore Biogen's strategic investment in expanding its immunology portfolio. Felzartamab could offer a new therapeutic option for patients with IgAN, a condition often marked by limited treatment choices. By offering a durable and potentially safer alternative to chronic immunosuppressive therapies, felzartamab holds promise for significantly improving patient outcomes in immune-mediated kidney diseases. As Phase III trials advance, the medical community will be closely watching to see if these preliminary benefits are confirmed in larger patient populations.

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