Contract for Phase IIb Study in Psoriasis
02.03.2021
Arctic Bioscience signs 3-year agreement Worth 75 million NOK with Smerud Medical Research International to conduct clinical study on psoriasis.
The agreement signed on Wednesday 3 March relates to the start of a phase IIb study for the treatment of mild to moderate psoriasis with the company’s drug candidate, HRO350, developed from herring roe oil.
The purpose of the clinical study is to investigate the efficacy and safety of HRO350 and to establish the optimal dose. The study will include more than 500 patients and is planned to be conducted in seven countries, including Norway. Recruitment of patients will start in Q1 2022.
Arctic Bioscience recently raised NOK 300 million and was listed on Euronext Growth in Oslo on 24 February. The agreement with Smerud Medical Research International ensures that the clinical study on HRO350 is on track and in line with the pharmaceutical development plan.
“We are delighted to have professional support for the implementation of this important study. Smerud Medical Research has a long history and a good reputation as a very professional Contract Research Organization.”
Ole Arne Eiksund, CEO of Arctic Bioscience.
Smerud Medical Research International has significant experience with clinical studies in psoriasis and will this week start by identifying centers for the study.
“The development of HRO350 from herring roe oil to a drug is an exceptional story – and it is great to take part in it. We look forward to collaborating with Arctic Bioscience on a comprehensive phase IIb study.”
Knut Smerud
CEO of Smerud Medical Research International
Technology Platform
Arctic Bioscience uses proprietary technology developed by our in-house science and technology team in Ørsta to manufacture high-quality marine extracts. The extraction technique and production process utilize specialized technology to gently separate the protein and lipid fractions in the herring roe. By using this technology the product fractions are protected from being exposed to unnecessary heating and detrimental amounts of oxygen. Extensive use of high manufacturing temperatures and exposure to oxygen will lead to deterioration of the delicate natural products extracted from the roe, where the complex polar lipid fraction of the roe is particularly susceptible to degradation upon exposure to harsh manufacturing conditions.
The new state-of-the-art manufacturing facility currently being developed in Ørsta will be built around the same manufacturing principles, thus ensuring production of high-quality materials both for nutraceutical and pharmaceutical applications. The factory will have one manufacturing line operating according to cGMP, which allows for in-house API manufacture for the pharmaceutical development of our complex polar lipid APIs.