Arctic Bioscience — Regulatory Filings 2023

Jan 12, 2023

Arctic Bioscience - Clinical Trial Application for HRO350 Phase IIb approved in the UK

Arctic Bioscience - Clinical Trial Application for HRO350 Phase IIb approved in the UK

Reference is being made to the stock exchange release from October 10th 2022,

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

Phase IIb clinical trial in mild-to-moderate psoriasis with the investigational

medicinal product (IMP) HRO350 was submitted to medicinal authorities.

Arctic Bioscience is pleased to announce that the CTA has been approved in the

UK. Today, January 12th 2023, the Health Research Authority (HRA) gave its

approval for clinical trial start in the UK "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). The CTA was simultaneously also approved by The United Kingdom (UK)

Medicines & Healthcare products Regulatory Agency (MHRA), the UK Research Ethics

Committee (REC). This is a major regulatory milestone in the drug development

program for HRO350.

Arctic Bioscience is currently in the process of activating the clinical trial

sites in the UK, and first patient inclusion is expected later this month.

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

-12 of the Norwegian Securities Trading Act.

For further information, please contact:

Christer L. Valderhaug

CEO of Arctic Bioscience AS

Mobile: +47 920 84 601

Email: christer@arctic-bioscience.com

Jone R. Slinning

CFO of Arctic Bioscience AS

Mobile: +47 948 75 469

Email: jone@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 team of highly competent people with experience in

developing marine oils and experience from global pharmaceutical companies.