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
Jone R. Slinning
CFO of Arctic Bioscience AS
Mobile: +47 948 75 469
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.