The starting point for the innovation project is the discovery that extract from herring roe can have an effect on mild-to-moderate psoriasis (1). In this project, further research will be carried out on the substances in herring roe and mechanisms of action in psoriasis, and is part of Arctic Bioscience's extensive research and development work. The project was carried out in collaboration with Nofima and Møreforsking.
Arctic Bioscience's investigational medicinal product (called HRO350) is an extract from herring roe, which has shown promising clinical efficacy on mild-to-moderate psoriasis (1). Herring roe is a residual raw material from herring fillet production. We therefore refine an untapped resource from the Norwegian fishing industry. The goal is to develop a new treatment option for patients with mild to moderate psoriasis. In this project the company has studied what effects the drug candidate has on a cellular level.
Arctic Bioscience, based at Sunnmøre, has extensive experience in lipid chemistry and product development, while Nofima and Møreforsking have expertise in biochemistry and cell biology. The research partners will investigate how the substances in herring roe affect several types of cells in the body. Nofima will study skin cells; by cultivating different types of cells that are part of the skin at the same time, we get a situation more similar to how they are in the body. Møreforsking will help study effects in different immune cells, which also play an important role in psoriasis. Together, the parties conducted research to understand the cellular mechanisms of this product.
Referanser:
1) Tveit KS, et al., A Randomized, Double-blind, Placebo-controlled Clinical Study to Investigate the efficacy of Herring Roe Oil for treatment of Psoriasis. Acta Derm Venereol. 2020 May 28;100(10):adv00154.
The project has built documentation on the MOA of HRO350 for a future MAA, and we have generated highly relevant data for the GMP development of HRO350. The results have added value to Arctic Bioscience´s future pharmaceutical pipeline.
Successfully obtaining an MAA for HRO350 supported by data from this project will have a large impact on the quality of life of patients suffering from mild-to-moderate psoriasis. Most psoriasis patients have non-severe disease, and current treatment options are mostly limited to drugs such as topical corticosteroids and phototherapy. Current treatment options are dissatisfactory to patients in terms of efficacy, ease-of-use and safety profile.
Arctic Bioscience AS is developing the investigational medicinal product HRO350 as an immunomodulatory first-in-class treatment of mild to moderate psoriasis. The drug development of HRO350 has an innovative sustainable and environmental approach, and is manufactured from a residual side-stream from sustainably sourced herring roe according to cGMP using proprietary technology and a sustainable natural raw material, by taking a residual side stream from herring fillet production and turning it into a pharmaceutical product. Results from this project will propel the clinical development of HRO350.
The successful development and launch of HRO350 would strengthen sustainable pharmaceutical value creation and creating high-skill jobs in the rural parts of Norway, with a planned factory located in Ørsta.
This project will be conducted by a constellation of collaborators in the marine and immunomodulatory fields, and will provide deeper understanding of the cellular mechanisms and complex structural characteristics of HRO350. The R&D activities include both advanced cellular studies and structural characterisation. The cellular activities of HRO350 will be evaluated both in primary immune cell models to understand the effects on the IL-23/IL-17 axis and in co-culture models to investigate its effects on cellular communication, extracellular matrix homeostasis, and receptor regulation. Sequential fractionation of HRO350 in conjunction with in vitro studies will be used to confirm the active part of the lipid matrix. Advanced characterisation of HRO350 and sub-fractions will focus on lipid class-specific fatty acid compositions.