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Bionyra Pharma Announces Positive Interim Phase 1 Results for BYN-002, a Long-Acting Anti-TL1A Antibody

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  • Favorable interim safety and tolerability profile observed across single and multiple ascending dose cohorts in healthy volunteers

  • Favorable immunogenicity, with single digit percentage Anti-drug Antibody (ADA) incidence at predicted therapeutic dose levels

  • Extended pharmacokinetics and target suppression support potential for every-3-to-6-month maintenance dosing

  • Findings support continued clinical development of BYN-002 in inflammatory bowel disease and other TL1A-driven diseases

  • Data presented at United European Gastroenterology (UEG) Week 2026 in Barcelona

PARIS & BOSTON, October 20, 2026--Bionyra Pharma, a clinical-stage biopharmaceutical company developing next-generation biologics designed to unlock the potential of multi-targeted biology in immune-mediated inflammatory diseases, today announced positive interim results from its ongoing Phase 1 first-in-human study of BYN-002 (TL-001), a long-acting anti-TL1A monoclonal antibody, that is in development to treat inflammatory bowel disease (IBD) and other TL1A-driven diseases.

The data are being presented in a late-breaking poster at United European Gastroenterology (UEG) Week 2026 in Barcelona: "BYN-002 (TL-001), A Next-Generation Anti-TL1A Antibody Demonstrating Potent Neutralization, Extended Pharmacokinetics, Durable TL1A Suppression and Favorable Immunogenicity: Interim Phase 1 SAD/MAD Results." The interim results from the ongoing randomized, double-blind, placebo-controlled Phase 1 healthy volunteer study evaluating the safety, pharmacokinetics, pharmacodynamics and immunogenicity of BYN-002 (NCT06867796) met all primary objectives of the study.

"These interim Phase 1 results provide compelling evidence that BYN-002 combines potent TL1A pathway inhibition with a pharmacokinetic profile that may enable highly convenient dosing intervals," said Frédéric Marrache, MD, PhD, MBA, Chief Executive Officer of Bionyra Pharma. "TL1A has emerged as one of the most important targets in inflammatory bowel disease and other TL1A-driven diseases, and we are excited by the profile emerging from this study and its ability to deliver durable target suppression and improved convenience."

Interim Phase 1 Highlights

In the ongoing study, healthy volunteers received either single ascending doses (SAD) or multiple ascending doses (MAD) of BYN-002. Interim results showed:

  • Favorable safety and tolerability, with no treatment-related serious adverse events, infusion reactions, deaths, or treatment-related discontinuations reported.

  • Dose-proportional pharmacokinetics, with terminal half-life ranging from 77.8 to 82.0 days in multiple-dose cohorts.

  • Sustained target suppression, with free soluble TL1A below the lower limit of quantification across all dose levels evaluated.

  • Anti-drug Antibody (ADA) responses primarily observed in lower-dose cohorts and immunogenicity at 9.1 % across MAD cohorts.

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