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.

Preliminary terminal half-life estimates support the potential for every-3-to-6-month maintenance dosing and further clinical development in IBD and in other TL1A-driven diseases.

View the full poster here (PDF): https://bionyra.com/wp-content/uploads/2026/10/LBP27-Bionyra-BYN-002-anti-TL1A-HLE-phase-1-HV-IA-UEGW-2026.pdf

About BYN-002 and BYN-003

BYN-002 (TL-001) is a humanized anti-TL1A monoclonal antibody with engineered Fc fragment for extended half-life. BYN-002 (TL-001) is part of Bionyra’s broader TL1A franchise, which also includes BYN-003 (TL-003), a next-generation TL1A×IL-23p19 bispecific antibody designed to address multiple inflammatory pathways simultaneously. Together, these programs reflect Bionyra’s strategy of advancing long-acting antibodies, multispecific biologics and combination approaches capable of delivering deeper efficacy, greater durability and improved convenience for patients with immune-mediated inflammatory diseases.

Bionyra licensed BYN-002 and BYN-003 from TrueLab Biopharmaceutical1 and holds exclusive worldwide rights outside Greater China.

About Bionyra Pharma

Bionyra Pharma is a clinical-stage biopharmaceutical company pioneering next-generation biologics for immune-mediated inflammatory diseases. The company develops long-acting antibodies, multispecific biologics and combination approaches designed to unlock the full potential of multi-targeted biology with the goal of achieving deeper efficacy, greater durability and improved convenience for patients. Bionyra’s pipeline spans Type 2 inflammation, inflammatory bowel disease and adjacent immune-mediated diseases and includes clinical-stage IL-25 and TL1A programs as well as next-generation multispecific and combination candidates. For more information, visit Bionyra.com and follow us on LinkedIn.

1 BYN-002 is also known as TL-001 and BYN-003 as TL-003

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