PARIS, France, and BOSTON, Mass.

October 20, 2026 — Bionyra Pharma, a clinical-stage biopharmaceutical company developing next-generation biologics for immune-mediated inflammatory diseases, 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. The investigational therapy is being developed for inflammatory bowel disease (IBD) and other TL1A-driven diseases. Presented at United European Gastroenterology (UEG) Week 2026 in Barcelona, the findings met all primary objectives of the randomized, double-blind, placebo-controlled study in healthy volunteers. The trial evaluates the candidate’s safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity following single and multiple ascending doses. The interim findings indicate a favorable safety profile, extended drug exposure and sustained suppression of free soluble TL1A, supporting continued investigation of BYN-002 and its potential for less frequent maintenance dosing.

Extended Half-Life and Sustained TL1A Suppression

Interim pharmacokinetic results showed dose-proportional exposure, with terminal half-life estimates ranging from 77.8 to 82.0 days in multiple-dose cohorts. The company said these findings support the potential for maintenance dosing every three to six months, although this schedule remains a development possibility rather than an established clinical regimen. Pharmacodynamic analyses showed that free soluble TL1A remained below the lower limit of quantification across all evaluated dose levels, indicating sustained target suppression in the study. BYN-002 is a humanized anti-TL1A monoclonal antibody incorporating an engineered Fc fragment designed to extend its half-life. The candidate is intended to inhibit the TL1A pathway, which Bionyra is targeting in inflammatory bowel disease and other immune-mediated conditions. The company believes that combining durable pathway suppression with longer dosing intervals could offer greater treatment convenience if supported by further clinical studies. The current results, however, are interim findings from healthy volunteers and do not establish efficacy in patients with inflammatory diseases..

Safety and Immunogenicity Findings Support Further Development

The interim analysis showed a favorable safety and tolerability profile across the single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Bionyra reported no treatment-related serious adverse events, infusion reactions, deaths or treatment-related discontinuations. Immunogenicity assessments found that anti-drug antibody (ADA) responses were primarily observed in lower-dose cohorts, with an incidence of 9.1% across the MAD cohorts. The company described this as favorable immunogenicity at the evaluated dose levels. These findings will help inform continued assessment of the candidate’s tolerability and dosing strategy as clinical development progresses. The Phase 1 study is registered under NCT06867796, and the interim data were presented in a late-breaking poster at UEG Week 2026 titled “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.” Further studies will be needed to characterize the candidate’s safety and determine whether the pharmacokinetic and pharmacodynamic findings translate into meaningful clinical benefits for patients.

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Bionyra Advances Its TL1A-Focused Biologics Pipeline

Chief Executive Officer Frédéric Marrache, MD, PhD, MBA, said the interim results demonstrate the potential to combine potent TL1A pathway inhibition with a pharmacokinetic profile that could support convenient dosing intervals. BYN-002 is part of Bionyra’s broader TL1A development program, which also includes BYN-003 (TL-003), a next-generation TL1A×IL-23p19 bispecific antibody designed to target multiple inflammatory pathways. The company’s pipeline spans Type 2 inflammation, inflammatory bowel disease and related immune-mediated conditions, with programs involving long-acting antibodies, multispecific biologics and combination approaches. Bionyra licensed BYN-002 and BYN-003 from TrueLab Biopharmaceutical and holds exclusive worldwide rights outside Greater China. The company plans to continue developing BYN-002 for IBD and other TL1A-driven diseases. Although the extended half-life and sustained target suppression are encouraging development signals, the candidate remains investigational, and its efficacy and longer-term safety in patients have yet to be established.

Source::Bionyra Pharma,press release