OSTON — Bionyra Pharma, a clinical-stage biopharmaceutical company developing treatments for immune-mediated inflammatory diseases, announced positive interim results from a Phase 1 clinical trial of BYN-002, an experimental long-acting antibody being developed for inflammatory bowel disease and related conditions.
The findings, presented at United European Gastroenterology Week 2026 in Barcelona, showed favorable safety, tolerability and pharmacokinetic profiles, supporting the potential for maintenance dosing every three to six months.
BYN-002, also known as TL-001, is a monoclonal antibody designed to block TL1A, a protein involved in inflammatory pathways associated with inflammatory bowel disease and other immune-mediated disorders.
The ongoing randomized, double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, pharmacodynamics and immunogenicity of BYN-002 in healthy volunteers receiving single or multiple ascending doses.
According to Bionyra, the interim results met all primary study objectives, with no treatment-related serious adverse events, infusion reactions, deaths or treatment-related discontinuations reported.
The treatment demonstrated a prolonged terminal half-life ranging from 77.8 to 82 days in multiple-dose cohorts, suggesting the potential for less frequent dosing than many existing treatments.
Researchers also observed sustained suppression of free soluble TL1A across all evaluated dose levels. Anti-drug antibody responses occurred primarily in lower-dose groups, with an overall incidence of 9.1% in the multiple-dose cohorts.
“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,” Marrache added.
The company said the findings support continued clinical development of BYN-002 in inflammatory bowel disease and other conditions driven by TL1A-related inflammation. The results remain preliminary, and the treatment has not yet been evaluated for efficacy in patients with inflammatory bowel disease in this study.
BYN-002 is part of Bionyra’s broader antibody development pipeline, which also includes BYN-003, an experimental bispecific antibody designed to simultaneously target TL1A and IL-23p19, two proteins involved in inflammatory responses.
Bionyra licensed both programs from TrueLab Biopharmaceutical and holds exclusive worldwide development and commercialization rights outside Greater China.
The company is developing long-acting and multispecific biologic therapies aimed at improving treatment durability, effectiveness and convenience for patients with chronic inflammatory diseases.
