Arctic Bioscience announces encouraging top-line results from the HeROPA clinical study

The HeROPA phase 2b study in mild-to-moderate psoriasis show encouraging results on key secondary endpoint with increasing durable efficacy up to week 52.

Data analyses are ongoing for the full Clinical Study Report. The company will hold a presentation with the full set of data from the study when the Clinical Study Report is ready in June, including statistical significance levels for all datapoints and relevant sub-analyses.

Among patients who completed 52 weeks of treatment:

• More patients treated with HRO350 achieved “clear” or “almost clear” skin (PGA 0/1) indicating minimal or no skin symptoms in both active groups compared to placebo
  • In the full population (PASI 3-10 at inclusion), 46 % of patients treated with high dose achieved a PGA 0/1 versus 36 % in the placebo group
  • In the group of patients with PASI 6-10 at inclusion, 45 % of patients in the high dose group achieved a PGA 0/1 versus 29 % in the placebo group

• 50 % reduction in the Psoriasis Area and Severity index (PASI50):
• As was observed for the 6-month readout of this endpoint, the placebo rate is high which obscures differences between the groups

• HRO350 was well tolerated throughout the study duration with no new safety concerns and no unexpected serious adverse events

PGA 0/1 is commonly used as a primary endpoint in studies, is a treatment-goal for psoriasis and is a harder endpoint to reach than a 50 % reduction in PASI (PASI50).

The Company is funded to expected cash flow positive nutra operations in 2026. Further development of the HRO350 in mild-to-moderate psoriasis, beyond the current phase 2b, will be funded separately through partnerships or specific project funding.

About the HeROPA study and HRO350:

The HeROPA trial was randomized, double blind and placebo controlled and investigated the efficacy and safety of two doses of the novel, oral drug candidate HRO350 versus placebo for the treatment of mild-to-moderate psoriasis. The HeROPA trial has been conducted in 5 countries in Europe: UK, Germany, Poland, Finland and Norway (EU-CT-2022-501850-12-00). HRO350 contains a first-in-class API (PeHeRo) with a mode-of-action differing from other oral treatment options under development.

Further supporting the data on clinical efficacy of HRO350 in this phase 2b clinical trial, Arctic Bioscience have presented data on the effects of HRO350 on skin cells and immune cells, including on SPMs in line with an anti-inflammatory effect in the skin at international congresses. Two publications are in peer-review process.

This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act. This stock exchange announcement was published by Jone R. Slinning, CFO at Arctic Bioscience AS, on the date and time as set out above. 

For further information, please contact:

Christer L. Valderhaug

CEO

Mobile: +47 920 84 601

Email: christer@arctic-bioscience.com

About Arctic Bioscience

Arctic Bioscience is a biotech company developing and commercializing pharmaceutical and nutraceutical products based on unique bioactive marine compounds.

The company is developing HRO350 – a novel oral drug candidate. HRO350 is being developed for treatment of patients with mild-to-moderate psoriasis. This is a large patient group in need of new effective medicines with beneficial safety profile.

Nutraceuticals from Arctic Bioscience are sold globally as bulk ingredients as well as finished goods under the ROMEGA® brand.

Arctic Bioscience is led by a highly skilled team of talents with diverse and highly relevant background.

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