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