Bioniz Therapeutics has reported positive top-line results from a Phase Ib clinical trial of BNZ-1 to treat Alopecia Areata (AA), a common, inflammatory, immune-mediated hair loss that leads to partial or complete loss of hair on the scalp and body.
The randomised, placebo-controlled trial was designed to analyse the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of various multiple doses of intravenous BNZ-1.
During the trial, BNZ-1 was administered to healthy adult subjects.
The trial evaluated three weekly dose cohorts and two alternate weekly dose cohorts in a dose-escalation manner.
It did not find any serious or severe adverse events (AEs), infusion-related reactions, or dose limiting laboratory toxicities.
According to Bioniz, the rate of adverse events reported in the trial was comparable between the pooled BNZ-1 and pooled placebo groups.
Sore throat and runny nose were found to be the only two common adverse events that happened more frequently in the overall BNZ-1 group, compared to the pooled placebo group.
Among other findings, the trial did not observe any dose / exposure-related adverse events.
Bioniz Therapeutics chief medical officer Paul Frohna said: “This Phase Ib study further characterises BNZ-1’s encouraging safety and tolerability profile while producing sustained, dose-dependent, and highly IL-2 / 15-specific pharmacodynamic effects with multiple dosing.
“These results establish initial clinical validation of BNZ-1’s potential to treat a variety of IL-2/9/15 cytokine-driven conditions with a novel mechanism.”
In addition, Bioniz has dosed a total of 53 healthy adult volunteers with BNZ-1 across two Phase I trials. So far, the trials have not observed any dose-limiting side effects, infusion reactions, or serious / severe adverse events.