Investors

Pharmaceutical Development

Arctic Bioscience is developing a proprietary first-in-class phospholipid drug for oral treatment for mild-to-moderate psoriasis. The lipid investigational medicinal product (IMP) HRO350 is a complex polar lipid matrix extracted from immature herring roe and is intended as an oral treatment option for psoriasis patients with a mild to moderate disease severity. Patients in this severity segment have few treatment options compared to the severe psoriasis population, and current treatments mainly consist of intermittent use of topical corticosteroids and light therapy.

Properties of Investigational Medicinal Product HRO350

HRO350 is a complex mixture of biologically important phospholipids

  • Composite effect from different lipid classes and their significant metabolites lead to clinically relevant immunoresolving properties.
  • Scientific research to investigate mode-of-action in psoriasis and immune-mediated disease states, includes studies on Specialized pro-resolving mediators (SPMs) (3) and cellular studies (4) with Norwegian R&D institutions and international scientific collaborators.

Building the Foundation Framework for a Robust Clinical Program

In Q2 of 2020 Arctic Bioscience published data from a single-center randomized, controlled pilot trial where a herring roe oil extract showed a statistically significant improvement in psoriasis (as measured by PASI) at 26 weeks compared to placebo (n=64). (1)

In Q1 of 2021 Arctic Bioscience presented long-term efficacy data from the same single-center randomized, controlled trial after open-label extension of active treatment up to 65 weeks. (2) Open-label extension of study from week 26 suggests sustained efficacy of herring roe oil in the treatment of mild-to-moderate psoriasis up to 65 weeks.

Arctic Bioscience received a grant from the EU innovation council for drafting the drug development program of HRO350.

Scientific advice on the draft drug development program for HRO350 was received from the EMA CHMP in Q4 2020.

Arctic Bioscience has completed a clinical phase IIb study with HRO350: Efficacy and
Safety Study of HRO350 in Patients with Mild-to-moderate Psoriasis (the ‘HeROPA’ Study)
(ClinicalTrials.gov ID NCT06125808). The study evaluated clinical efficacy and safety of
HRO350 as well as to determine a suitable dose for patients with mild-to-moderate
psoriasis.

References

  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. doi: 10.2340/00015555-3507. PMID: 32378724.
  2. Tveit KS et al. Long Term Efficacy and Safety of Herring Roe Oil in the Treatment of Psoriasis, a 39-week Open-label Extension Study. International Journal of Clinical and Experimental Medical Sciences. Vol. 7, No. 1, 2021, pp. 13-20. doi: 10.11648/j.ijcems.20210701.13
  3. Ringheim-Bakka T. et al, Phospholipid esters from herring roe promotes SPM biosynthesis in human monocyte-derived macrophages and a keratinocyte/fibroblast co-culture with implications for the treatment of psoriasis. Available via: BioRxiv (doi: https://doi.org/10.1101/2025.02.20.639253)
  4. Mildenberger J. et al., Herring roe oil exerts anti-psoriatic and immunomodulatory effects on the IL-17/23 signaling axis in macrophages, T-cells and a keratinocyte and fibroblast co-culture. Available via: BioRxiv (doi: https://doi.org/10.1101/2025.04.22.650092)