Zealand Pharma has shared positive Phase I multiple ascending dose (MAD) topline results for the company’s novel Kv1.3 ion channel blocker, ZP9830. 

The MAD part of the first-in-human, single-centre, randomised, double-blind, placebo-controlled Phase I trial was designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple doses of ZP9830 in 32 healthy male and female participants. 

Multiple doses of ZP9830 were found to be safe and well tolerated in this trial with a treatment duration of four weeks and a safety follow-up period until day 41.  

No dose-limiting safety findings or other significant safety concerns were observed. All treatment-emergent adverse events (TEAEs) in participants receiving ZP9830 were non-serious and mild in severity. No clinically relevant safety findings were observed. 

“These results represent an encouraging milestone for ZP9830. In this multiple ascending dose part of the Phase I trial, ZP9830 was well tolerated and no dose limiting safety findings were observed. The findings support continued development in studies of longer duration,” said Dr David Kendall, Chief Medical Officer of Zealand Pharma. “This brings us one step closer to our goal of delivering a novel immunological treatment to patients. We are excited to investigate the potential of this novel asset across multiple autoimmune and inflammatory diseases. Our Phase Ib trial in plaque psoriasis is already under way, and the data announced today give us the confidence to expand the development programme and explore an additional autoimmune disease in 2027.” 

Zealand Pharma initiated a Phase Ib trial with efficacy endpoints, investigating ZP9830 in people with plaque psoriasis. The trial was initiated on the back of positive topline results from the single ascending dose (SAD) part of the combined SAD/MAD Phase I clinical trial with ZP9830 announced earlier this year.