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

  • 2017

    Composite effect from different lipid classes and their significant metabolites lead to clinically relevant immunoresolving properties.

  • 2017

    Company conducting cellular studies with Norwegian R&D institutions to further investigate mode-of-action in psoriasis and immune-mediated disease states.

STANDARD STØRRELSE ARCTICNUTRITION.NO (6)

Building the Foundation Framework for a Robust Clinical Program

  • 8

    Pilot clinical trial initiated


  • 8

    Pilot clinical trial completed

  • 9

    First clinical study results published

  • 10

    Scientific advice from the EMA

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 is currently planning to enter a clinical phase IIb study with HRO350 to evaluate 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