Biotech firm Zealand Pharma has reported positive Phase 1 multiple ascending dose (MAD) results for ZP9830, its investigational Kv1.3 ion channel blocker, strengthening the case for further development of the experimental treatment across autoimmune and inflammatory diseases.

 

The four-week study found that multiple doses of ZP9830 were safe and well tolerated, with no dose-limiting safety findings or other significant safety concerns. The results support the drug’s continued development in longer-duration trials, the company said.

 

The MAD segment of the first-in-human, randomised, double-blind, placebo-controlled Phase 1 trial involved 32 healthy male and female participants. Safety monitoring continued until day 41.

 

All treatment-emergent adverse events reported among participants receiving ZP9830 were non-serious and mild. The company also reported no clinically relevant safety findings in vital signs, 12-lead electrocardiogram (ECG) recordings, physical examinations or safety laboratory parameters.

 

Pharmacokinetic (PK) findings further supported continued development of the drug in studies of longer duration.

 

"These results represent an encouraging milestone for ZP9830. In this multiple ascending dose part of the Phase 1 trial, ZP9830 was well tolerated and no dose limiting safety findings were observed. The findings support continued development in studies of longer duration," said 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 1b trial in plaque psoriasis is already under way, and the data announced today give us the confidence to expand the development program and explore an additional autoimmune disease in 2027.”

 

Zealand Pharma has already launched a Phase 1b trial of ZP9830 in people with plaque psoriasis, incorporating efficacy endpoints to assess the drug’s potential benefit.

 

The trial followed positive topline results from the single ascending dose (SAD) segment of the combined SAD/MAD Phase 1 clinical trial, which the company announced earlier this year.

 

With the latest safety and tolerability findings in hand, Zealand Pharma plans to advance ZP9830 into longer-duration studies and explore its potential in an additional autoimmune disease in 2027.

 

The results mark an early development milestone for the investigational drug. Further clinical studies will be needed to establish its efficacy and longer-term safety in patients with autoimmune and inflammatory conditions.