Anti-interleukin-5 monoclonal antibody for asthma passes phase 1 trial

A novel long-acting anti-interleukin-5 monoclonal antibody, SHR-1703, demonstrates promising efficacy with good tolerability in patients with eosinophilic asthma, according to a phase 1 study.

Researchers performed a single ascending dose study and randomized eligible asthma patients to receive SHR-1703 (400 or 600 mg) or placebo. They followed up to day 281. Safety and tolerability were the primary endpoints.

Most treatment-emergent adverse events (TEAEs) were mild or moderate in severity, and the incidence of TEAEs did not significantly differ between the two treatment groups. The median T_max range was 13.9 with SHR-1703 400 mg and 10.3 with the 600-mg dose. SHR-1703 had an extended mean half-life of 75.1 and 72.6 days for the respective doses.

Furthermore, treatment with SHR-1703 resulted in significant and rapid reductions in peripheral blood eosinophils (~50 percent) in 1 day. The largest mean decline of eosinophils from baseline was 87.7 percent for the 400-mg dose and 91.1 percent for 600 mg. This effect persisted for over 100 days, and the eosinophil levels remained below the baseline until the end of follow-up.

“Interleukin 5 is an important target for the treatment of eosinophil-associated diseases including eosinophilic asthma,” the researchers said. “SHR-1703 is an innovative humanized anti-interleukin-5 monoclonal antibody designed to improve asthma control.”