Harbour BioMed has announced the online publication of the results from the first-in-human Phase 1 clinical trial of its TSLP-targeted antibody, HBM9378 (also referred to as SKB378 or WIN378). This antibody, developed in collaboration with Kelun Biotech, boasts a fully human sequence, minimal immunogenicity, high bioavailability, and an extended half-life. It is designed for subcutaneous administration.

The trial, a randomized, double-blind, placebo-controlled study involving single ascending doses, revealed that the incidence of treatment-emergent adverse events (TEAEs) was similar in both the treatment and placebo groups. Notably, there was no indication of increased safety risks with escalating doses. The median time to reach peak concentration ranged from 4.05 to 14.1 days, while the mean half-life spanned from 55.0 to 65.8 days. Exposure to the antibody increased proportionally with the dose. The positivity rate for anti-drug antibodies (ADAs) was a mere 5%, and no adverse reactions were observed at the injection site.

Harbour BioMed and Kelun Biotech jointly possess the global rights to HBM9378. In January 2025, they licensed partial regional rights to Windward Bio. Presently, Harbour BioMed has concluded a Phase 1 trial of HBM9378 for moderate-to-severe asthma in China. Windward Bio has commenced a global Phase 2 trial, and its Investigational New Drug (IND) application for chronic obstructive pulmonary disease (COPD) has received approval from China's National Medical Products Administration (NMPA).