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Arctic Bioscience Regulatory Filings 2023

Mar 7, 2023

3536_rns_2023-03-07_73359d06-1e13-436f-a461-5553081ec15b.html

Regulatory Filings

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Arctic Bioscience - The HeROPA phase IIb clinical trial approved in Norway, Finland, Germany and Poland

Arctic Bioscience - The HeROPA phase IIb clinical trial approved in Norway, Finland, Germany and Poland

Reference is being made to the stock exchange release from January 12[th], 2023,

where Arctic Bioscience announced that the Clinical Trial Application (CTA) for

a phase IIb clinical trial in mild-to-moderate psoriasis with the

investigational medicinal product HRO350 was approved in the United Kingdom

(UK). Arctic Bioscience is pleased to announce that the CTA also has been

approved in Norway, Finland, Germany and Poland.

As announced on January 31[st], 2023, Arctic Bioscience met a key milestone when

the first patient was included in the clinical trial "A phase IIb, multicenter,

randomized, double-blind, placebo-controlled, dose-finding, efficacy and safety

study of HRO350 in patients with mild-to-moderate psoriasis" (the 'HeROPA'

study) in the UK. The study is now also approved in the EU/EEA. With these

approvals, we have achieved inclusion of all five countries we had intended for

in the study. Sites in the EU/EEA countries participating in the trial will be

activated and recruitment of patients can start in these countries.

The large, international HeROPA study will include 519 patients in these five

countries. A six-month inclusion period is expected, with first data readout six

months after last patient is enrolled.

This information is subject to the disclosure requirements pursuant to section 5

-12 of the Norwegian Securities Act.

For more information, please contact:

Christer L. Valderhaug

CEO

Phone: +47 920 84 601

E-mail: [email protected]

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 investigational 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 team of highly competent people with experience in

developing marine oils and experience from global pharmaceutical companies.