Bionyra Pharma has announced positive interim results from its ongoing Phase I 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.  

The interim results from the study evaluating the safety, pharmacokinetics, pharmacodynamics and immunogenicity of BYN-002 met all primary objectives.  

“These interim Phase I 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, 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.”  

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

  • Favourable 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. 
  • BYN-002 (TL-001) is a humanised 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. 

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