Boston — Bionyra Pharma announced that the first healthy volunteers have been dosed in a Phase 1 study of BYN-001, its long-acting anti-IL-25 monoclonal antibody being developed for atopic dermatitis.
The study has been initiated in Australia and is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic profile of BYN-001 in healthy volunteers. The first cohort has been enrolled in the single ascending dose portion of the trial.
BYN-001 targets IL-25, an upstream regulator of Type 2 inflammation that is implicated in atopic dermatitis. The antibody also incorporates half-life extension technology intended to support prolonged target engagement and less frequent dosing.
“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, M.D., Ph.D., M.B.A., 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 influences several biological processes associated with atopic dermatitis, including itch and skin barrier dysfunction. Bionyra is developing BYN-001 to target this pathway with the aim of providing broader control of Type 2 inflammation.
The company is also building a broader IL-25 pipeline that includes a preclinical IL-25×IL-13 multispecific antibody and additional potential combination approaches.
BYN-001 is part of Bionyra’s strategy of developing long-acting antibodies, multispecific biologics and combination therapies for immune-mediated inflammatory diseases.
Bionyra is also advancing clinical-stage programs BYN-002, an anti-TL1A antibody incorporating half-life extension technology, and BYN-003, a TL1A×IL23p19 multispecific program.
Bionyra licensed BYN-001 from NovaRock Biotherapeutics and BYN-002 and BYN-003 from TrueLab Biopharmaceutical. The company holds exclusive worldwide rights to the programs outside Greater China.
