Arctic Bioscience – Analysis on HeROPA study shows statistically significant effects of psoriasis drug candidate HRO350 on inflammation

Analysis on blood samples from the psoriasis HeROPA-trial revealed statistically significant effects of HRO350 versus placebo on Systemic Immune-inflammation Index (SII) in patients with mild-to-moderate psoriasis. Significantly more patients treated with HRO350 achieved a ≥ 25% reduction in a systemic inflammatory marker at both 26 weeks and 1 year compared to placebo. Among patients with lower baseline systemic inflammation, this reduction was accompanied by statistically significant improvements in psoriasis skin symptoms and quality of life, shown through achievement of sPGA0/1 and DLQI0/1 in the HRO350 group after 1 year.

The results show that patient screening based on baseline SII in mild-to-moderate psoriasis may reduce the inherent uncertainty in the patient target group for HRO350 in further development phase. Inflammation plays a key role in psoriasis and can be measured through biomarkers. Systemic inflammation measured in blood provides a distinct perspective on disease severity compared to skin symptoms. These findings on the impact of HRO350 on inflammation aligns with in vitro cellular data indicating involvement of HRO350 in resolution of inflammation.

“These new findings showing the potential of HRO350 in reducing inflammation are of significant value for Arctic Bioscience. The data strengthens a further development within mild-to-moderate psoriasis, as well as the potential of general effects on inflammation which may strengthen our HRO350-asset. The findings from these analyses will also be important as we now enter commercial dialogues with potential partners”, says Christer Valderhaug, CEO.

The Systemic Immune-inflammation Index (SII) is a biomarker which reflects systemic inflammation and immune status. SII has been found to correlate with psoriasis severity, risk of disease activation, and decreases with effective systemic therapy.

“Psoriasis is an inflammatory skin disease, which is associated with premature cardiovascular disease. SII is a measure of systemic inflammation, which is an independent risk factor for cardiovascular disease. A high SII is associated with treatment resistance to even highly effective biologic drugs. For the patients with a lower amount of inflammation in the HeROPA trial, the drug is working. The treatment shows a difference to placebo in patients with lower inflammation – and it lowers inflammation in all patients, which may also be beneficial for long term cardiovascular health”, says Professor Brian Kirby, Ireland, who has served on the Data Monitoring Committee for the HeROPA trial.

The HeROPA study is a phase 2b study investigating efficacy and safety of HRO350 in mild-to-moderate psoriasis and included over 500 patients in five countries. HRO350 was well tolerated throughout the study, with no safety concerns or drug-related serious adverse events reported. All the patients in the HeROPA trial had mild-to-moderate psoriasis as assessed by their skin symptoms (PASI < 10). However, a significant portion of the patients had an SII at start that could be associated with more severe inflammation.

Psoriasis is a chronic, immune-mediated inflammatory disease. If untreated, subclinical inflammation may increase patients' risks for disease progression to severe psoriasis. Early treatment intervention for psoriasis may help reducing risk of developing multiple comorbidities, including psoriatic arthritis.

Arctic Bioscience strongly believe there is a major market potential for HRO350 in mild-to-moderate psoriasis and will seek partnerships for further development.

Significant effects on systemic inflammation, particularly among patients with lower baseline systemic inflammation, suggest platform potential for HRO350. The observed anti-inflammatory activity positions HRO350 as a potential treatment option for inflammatory conditions.

Please see attachment for more details and results from the analyses conducted.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

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.

For more information, please contact:

Christer L. Valderhaug

CEO

Phone: +47 920 84 601

E-mail: christer@arctic-bioscience.com

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