Arctic Bioscience announced 12-month results from its HeROPA phase 2b clinical trial evaluating HRO350, a novel oral drug candidate for mild-to-moderate psoriasis, showing encouraging efficacy signals despite missing the primary endpoint due to an unexpectedly high placebo response.
Trial Results Show Mixed Outcomes
The 52-week placebo-controlled study failed to meet its primary endpoint of PASI50 at 26 weeks, primarily attributed to an unusually high placebo response rate that complicated data interpretation. However, the trial demonstrated potential through key secondary endpoints, with the per protocol population approaching statistical significance (p = 0.07) for Physician's Global Assessment (PGA) 0/1 after one year of treatment.
"A challenge with analyzing these data has been the high placebo rate. Numerically, HRO350 is better than placebo on key secondary endpoints, and a consistent trend can be seen across endpoints for the patients who remained on treatment for a full year," said Medical Director Runhild Gammelsæter.
Relevant subgroups within the study population achieved statistical significance (p < 0.05), supporting the therapeutic potential of HRO350 in specific patient populations.
Safety Profile Remains Favorable
Throughout the extended study period, HRO350 demonstrated a reassuring safety profile with no safety concerns or drug-related serious adverse events reported. This favorable tolerability profile represents a significant advantage for a chronic condition requiring long-term treatment.
Professor Ingeborg Bachmann, principal investigator in the HeROPA study, noted: "We saw that many patients benefited from taking part in the study, and at Haukeland we have skilled study nurses who have provided the patients with good care. There is an effect in the treatment groups, the mystery is placebo, which we need to understand better in order to design a next study with HRO350."
Strategic Development Plans
Despite the primary endpoint miss, Arctic Bioscience remains confident in HRO350's market potential for mild-to-moderate psoriasis, describing it as "a large patient group in need of new effective medicines with beneficial safety profile."
CEO Christer L. Valderhaug expressed optimism about the compound's future: "We are encouraged by the efficacy and safety profile of HRO350. These results reinforce our belief in the potential of this asset to address chronic conditions like psoriasis. We will now evaluate strategic opportunities for further development and regulatory engagement for HRO350."
The company plans to seek partnerships for further development of HRO350, leveraging the overall data package that supports the drug's potential despite the primary endpoint challenges.
Novel Marine-Based Approach
HRO350 represents a novel oral drug candidate based on unique bioactive marine compounds, differentiating it from existing psoriasis treatments. Arctic Bioscience specializes in developing and commercializing pharmaceutical and nutraceutical products derived from these marine-based bioactive compounds.
The company's approach addresses the significant unmet medical need in mild-to-moderate psoriasis, where patients require effective treatments with favorable safety profiles for long-term management of this chronic inflammatory skin condition.
