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 that the first healthy volunteers have been dosed in the Phase 1 study of BYN-001, the company’s long-acting anti-IL-25 monoclonal antibody being developed for atopic dermatitis.

The study, designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic profile of BYN-001 in healthy volunteers, has been initiated in Australia, with the first cohort of healthy volunteers enrolled in the single ascending dose (SAD) portion of the trial.

“Initiation of the BYN-001 Phase 1 study marks an important milestone for Bionyra and advances our mission of bringing differentiated immunology therapies to patients with significant unmet medical needs,” said Frédéric Marrache, MD, PhD, MBA, Chief Executive Officer of Bionyra. “We believe IL-25 represents one of the most compelling emerging targets in Type 2 inflammation. We aspire to deliver therapeutics with better efficacy and convenience for patients.”

IL-25 acts upstream in the Type 2 inflammatory cascade and influences multiple biological processes implicated in atopic dermatitis, beyond that of downstream cytokines like IL-4 and IL-13. IL-25 contributes to itch and skin barrier dysfunction, including modulation of key mediators of pruritus and effects on epidermal barrier integrity. By targeting IL-25, Bionyra aims to address a distinct and non-redundant disease mechanism with the potential to provide broader control of Type 2 biology than inhibition of downstream cytokines alone.

BYN-001 combines potent IL-25 inhibition with half-life extension (HLE) technology designed to support prolonged target engagement and infrequent dosing. The program is intended not only as a potential standalone therapy, but also as a foundation for next-generation multi-targeted approaches. Bionyra is advancing a preclinical IL-25×IL-13 multispecific antibody program and evaluating additional IL-25-based combination opportunities as part of its broader pipeline strategy.

BYN-001 is part of Bionyra’s broader strategy to unlock the potential of multi-targeted biology through long-acting antibodies, multispecific biologics and combination approaches designed to address multiple disease pathways simultaneously. Bionyra is also advancing clinical-stage programs BYN-002 (anti-TLA1 HLE) and BYN-003 (TL1A*IL23p19 HLE) targeting TL1A-mediated diseases and developing preclinical multispecific and combination programs intended to deliver deeper efficacy, greater durability and improved convenience for patients.

About BYN-001, BYN-002 and BYN-003

Bionyra licensed BYN-001 from NovaRock Biotherapeutics1, and BYN-002 and BYN-003 from TrueLab Biopharmaceutical2 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-001 is also known as NBL-023

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

 

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