Reference is being made to the stock exchange release from January 12th, 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 31st, 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
Phone: +47 920 84 601
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.