Arctic Bioscience (ABS) Study Result summary

Study design and objectives

• Phase IIb HeROPA study evaluated HRO350/HR0350 in 521 patients with mild-to-moderate psoriasis across multiple European countries, using a randomized, placebo-controlled design with primary and secondary endpoints at 26 and 52 weeks.

• The primary endpoint was PASI50 at 26 weeks; secondary endpoints included change in PASI and Physician's Global Assessment (PGA 0/1) at 52 weeks.

• Study protocol was based on scientific advice from the EMA, with dosing arms of 2100 mg and 1050 mg HRO350 versus placebo.

• The study included a follow-up period post-treatment to assess durability and safety.

Efficacy results

• The primary endpoint (PASI50 at 26 weeks) was not met due to high placebo response and disease fluctuation in mild cases.

• Nearly half of patients on high-dose HRO350 achieved clear or almost clear skin (PGA 0/1) at 52 weeks, compared to 34% on placebo (p=0.073).

• Stricter endpoints like PGA 0/1 in the per protocol population approached statistical significance (p=0.07).

• Statistically significant results (p<0.05) were observed in relevant subgroups, including patients ≥50 years and those weighing ≤98 kg.

• Efficacy was consistent in patients who completed one year of treatment, with higher response rates in certain subgroups.

Safety and tolerability

• HRO350/HR0350 demonstrated a robust safety profile with no serious safety concerns, drug-related SAEs, or SUSARs reported.

• The treatment was well tolerated over 12 months, with few drug-related adverse events and low dropout rates.

• Safety findings were consistent with previous studies and confirmed by independent data monitoring.

• Full safety data will be detailed in the clinical study report.