Bionyra Pharma has dosed the first healthy volunteers in a Phase I trial of BYN-001, its long-acting anti-IL-25 monoclonal antibody, which is being developed for the treatment of atopic dermatitis.
The company confirmed the launch of the study in Australia, where the first group of participants is enrolled in the single ascending dose segment of the trial.
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The study will assess the tolerability, safety, pharmacodynamics and pharmacokinetics in healthy individuals.
Bionyra Pharma CEO Frédéric Marrache said: “Initiation of the BYN-001 Phase I study marks an important milestone for Bionyra and advances our mission of bringing differentiated immunology therapies to patients with significant unmet medical needs.
“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.”
BYN-001 is intended to act against IL-25, a target identified as acting upstream in the type 2 inflammatory cascade.
According to the company, IL-25 is involved in multiple biological processes relevant to atopic dermatitis, including itch and skin barrier dysfunction.
Bionyra Pharma’s approach looks to target non-redundant disease mechanisms and offer broader control of type 2 biology compared with agents focusing on cytokines further downstream, such as IL-4 and IL-13.
BYN-001 incorporates half-life extension technology, which is designed to prolong its activity in the body and enable less frequent dosing.
Besides its potential as a standalone treatment, Bionyra Pharma is investigating this antibody within preclinical multispecific programmes, including IL-25×IL-13 combinations, as part of its pipeline strategy.
BYN-001 was licensed from NovaRock Biotherapeutics while the company’s other assets, BYN-002 and BYN-003, which target TL1A-mediated diseases, were licensed from TrueLab Biopharmaceutical.
Bionyra Pharma retains exclusive worldwide rights to these candidates outside Greater China.
The company’s broader research efforts focus on long-acting antibodies, multispecific biologics and combination approaches for immune-mediated inflammatory diseases, including type 2 inflammation and inflammatory bowel disease.
