Arctic Bioscience — Regulatory Filings 2022

Mar 15, 2022

Arctic Bioscience AS receives positive opinion on Paediatric Investigational Plan from the European Medicines Agency

Arctic Bioscience AS receives positive opinion on Paediatric Investigational Plan from the European Medicines Agency

Arctic Bioscience AS, a biotechnology company developing and commercializing

nutraceutical and pharmaceutical products based on the unique bioactive marine

compounds from herring roe, announces the European Medicines Agency (EMA)

decision on the agreement of a paediatric investigation plan (PIP) for the

Company's investigational medicinal product, HRO350, and on the granting of a

deferral. This follows a positive opinion from the Paediatric Committee (PDCO)

on the paediatric investigation plan. The paediatric investigation plan outlines

the company´s intention to investigate HRO350 for children with psoriasis.

The Paediatric Committee of the EMA facilitates the development and availability

of medicines for children, and provides opinions on the quality, safety and

efficacy of a medicine for use in the paediatric population. As part of drug

development programs, pharmaceutical companies must submit a paediatric

investigation plan outlining the strategy for investigation of new medicines in

the paediatric population. An agreed PIP is a prerequisite for filing for

marketing authorization for any new medicines in Europe. Consequently, EMA

required this PIP prior to Arctic Bioscience initiating the Phase IIb study for

HRO350 in adults. The PIP is therefore a critical component of the regulatory

drug development journey for HRO350.

Not all medicines being developed for adults are deemed suitable for use in

children. Based on the data submitted by Arctic Bioscience, the PDCO notes no

concerns on potential long term safety/efficacy issues in relation to paediatric

use.

Christer Valderhaug, CEO commented:

"We are now preparing for the Phase IIb study initiation in 2022 and a

paediatric investigational plan is necessary for us to move forward with our

clinical development program. I am very pleased that the team has proven its

capability to reach such a significant milestone. In addition to paving the way

forward for trials of HRO350 in adults, it also expands the future potential of

HRO350 for use in children. Thus, showing Arctic Bioscience's dedication to

investigate the efficacy of HRO350 in the treatment of paediatric psoriasis."

Onset of psoriasis can occur during childhood or adulthood

Psoriasis is a chronic, non-communicable, inflammatory skin disorder with no

clear cause or cure. It is estimated that psoriasis affects 2-3 % of the

population worldwide and can have a profound impact on patient´s quality of life

(Yeung 2013; World Health Organization 2016). Psoriasis in children and adults

manifests similar physical symptoms, genetics, cytokine profiles and is

associated with the same comorbidities. The onset of psoriasis can occur during

childhood or adulthood, with one-third of the cases beginning in children under

the age of 18. Paediatric psoriasis is a common disease, affecting approximately

1% of children (Menter 2020; Augustin 2010; Bronckers 2015; Queiro 2014).

Treatment options for children with psoriasis are severely limited

Currently there are few approved treatment options for psoriasis in children,

mostly limited to biologic medicines that are only approved for moderate and

severe disease. Although topical corticosteroids are commonly used, but their

use should be limited as corticosteroids are associated with adverse events in

children.

HRO350 is an investigational medicinal product being developed for the treatment

of mild-to-moderate psoriasis. The drug development program for HRO350 is

planned to include a large phase IIb clinical trial and a following phase III

trial, in adults with mild-to-moderate psoriasis.

Arctic Bioscience´s paediatric investigational plan for HRO350 is intended for

children less than 18 years of age with paediatric psoriasis. The plan includes

development of age appropriate pharmaceutical forms suitable for use in

children. A deferral for completion of the paediatric investigational plan is

granted until after the planned completion of the development program for HRO350

for adults.

Resources:

· Link to PIP on EMA website: Information about the PDCO and PIPs in the

EMA: https://www.ema.europa.eu/en/committees/paediatric-committee-pdco

References:

· Augustin M. et al. Epidemiology and comorbidity of psoriasis in children. Br

J Dermatol. 2010 Mar;162(3):633-6. doi: 10.1111/j.1365-2133.2009.09593.x. Epub

2009 Nov 18. PMID: 19922529.

· Bronckers IM, Paller AS, van Geel MJ, van de Kerkhof PC, Seyger MM.

Psoriasis in Children and Adolescents: Diagnosis, Management and Comorbidities.

Paediatr Drugs. 2015 Oct;17(5):373-84. doi: 10.1007/s40272-015-0137-1. PMID:

26072040; PMCID: PMC4744260.

· Menter A. Et al. Joint American Academy of Dermatology-National Psoriasis

Foundation guidelines of care for the management and treatment of psoriasis in

pediatric patients. J Am Acad Dermatol. 2020 Jan;82(1):161-201. doi:

10.1016/j.jaad.2019.08.049. Epub 2019 Nov 5. Erratum in: J Am Acad Dermatol.

2020 Mar;82(3):574. PMID: 31703821.

· Queiro R, Tejón P, Alonso S, Coto P. Age at disease onset: a key factor for

understanding psoriatic disease. Rheumatology (Oxford). 2014 Jul;53(7):1178-85.

doi: 10.1093/rheumatology/ket363

· World Health Organization?. Global report on psoriasis. World Health

Organization 2016. https://apps.who.int/iris/handle/10665/204417

· Yeung H, et al. Psoriasis severity and the prevalence of major medical co

-morbidities: a population-based study. JAMA Dermatol. 2013 October 1;

149(10):1173-1179

For more information, please contact

Christer Valderhaug

CEO Arctic Bioscience

Phone:  +47 920 84 601

About Arctic Bioscience[RG1]

Arctic Bioscience is a biotech company developing and commercializing

nutraceutical and pharmaceutical products based on unique bioactive marine

compounds from herring roe.

The company is developing HRO350 - a novel investigational drug candidate based

on herring roe. 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.

Herring roe contains lipids that are essential in maintaining cell membranes and

omega -3 fatty acids that contribute to the normal functioning of brain, heart,

and vision. Nutraceuticals from Arctic Bioscience are sold globally as bulk

ingredients as well as finished goods under the ROMEGA® brand. The strategy is

to switch sales from bulk to finished goods and focus markets are USA and China.

Arctic Bioscience is led by a team of highly competent people with experience in

developing marine oils and experience from global pharmaceutical companies.

[RG1]Please note we made some changes in the boiler text. Is this acceptable?

We should regardless update our existing boiler text.