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 (IMP) HRO350 was approved in the United Kingdom (UK).
Arctic Bioscience has met a key milestone in the drug development program for HRO350. The first patient has been 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. This is the start of the clinical study.
“This is the kickoff. Our innovative and highly competent team has been working diligently for several years towards this breakthrough. Following the successful approval from the UK medicines authorities, a clinic in the UK has included the first patient. This is a great occasion for Arctic Bioscience, which was listed on EuroNext Growth in 2021 raising funds to conduct this study”, comments Christer L. Valderhaug, CEO of Arctic Bioscience.
The international study is planned to be conducted in five countries, with a total of 519 patients. A six-month inclusion period is expected, with first data readout six months after last patient is included.
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.