A feasibility study on the development of Psorax35 as the first and only oral treatment for mild-to-moderate psoriasis with positive effects on co-morbidities.

Projektinformationen

PsoraxPlan

ID Finanzhilfevereinbarung: 877522

DOI

10.3030/877522

Projekt abgeschlossen

EK-Unterschriftsdatum 26 Juli 2019

Startdatum 1 August 2019

Enddatum 31 Januar 2020

Finanziert unter

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Gesamtkosten

€ 71 429,00

EU-Beitrag

€ 50 000,00

Koordiniert durch

ARCTIC NUTRITION AS
Norway

Periodic Reporting for period 1 - PsoraxPlan (A feasibility study on the development of Psorax35 as the first and only oral treatment for mild-to-moderate psoriasis with positive effects on co-morbidities.)

Berichtszeitraum: 2019-08-01 bis 2020-01-31

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

The objective of the main project is to commercialize HCP350 – the first oral medicine for mild to moderate psoriasis with positive effect on comorbidities. Current psoriasis medicines have limited efficacy, serious side effects and waning effect over time. According to WHO there is a global need for new safe, tolerable, effective and convenient psoriasis medicines that can be given without close monitoring by health personnel. Developing and documenting HCP350 as an efficacious treatment of mild and moderate psoriasis will lay the foundation for further investigations in severe psoriasis. Comorbidities like cardiovascular disease and arthritis will most probably be positively affected by HCP350 and add to the value of the product. If HCP350 is shown to be effective, psoriasis patients will experience better quality of life, and society will benefit from reduced direct medical expenses and increased working capability of many patients today suffering from psoriasis. It will also enable Arctic Nutrition AS to create a growing business and have the ability to further expand and create new jobs.

The objective of the PsoraxPlan feasibility study is to deliver a comprehensive feasibility analysis of the development of HCP350 as a medicinal product for the global market to treat mild-to-moderate psoriasis. The feasibility analysis will include a thorough assessment of technical, regulatory, market access, and financing feasibility including a risk analysis and risk mitigation plan. Of particular importance are the specific feasibility analyses on aspects related to regulatory affairs (systematic review of the literature for omega-3 in the treatment of psoriasis; initial outlining of the clinical development plan; and outline for scientific advice meetings with regulatory authorities), clinical development (protocol outlines, budgets and site/patient recruitment feasibility), strategic innovation funding (grant screening) as well as further screening of potential marketing partners.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

The SME Instrument phase 1 project was organized as four main actions, each with 3-4 tasks:

1. Assess technical development feasibility
a. Mechanism of action assessments to specify the active pharmaceutical ingredient(s)
b. Manufacturing development: initial planning of trans-tech to in-house production
c. GMP manufacturing: alternative contract manufacturers

2. Assess regulatory feasibility
a. Plan scientific advice meeting(s) with relevant authorities; short-list relevant topics
b. Assess bibliographic writing needs, i.a. systematic review of omega-3 in the treatment of psoriasis
c. Early outlining of the clinical development plan, including protocol outlines, budgets and site feasibility analysis for the dose-finding phase 2b and confirmatory phase 3 clinical trials
d. Assessment of possible secondary indications for HCP350

3. Assess market access feasibility
a. Map current standard practices and reimbursement status in the initial markets
b. Identify and meet with Key Opinion Leaders in each of those pilot markets
c. Identify and short-list potential development partners, technical as well as commercial

4. Assess financing feasibility
a. Detail budget for the next 36 months of product development
b. Develop strategic innovation funding plan (R&D grants)
c. Develop marketing/commercial partner licensing term sheets


The analysis has provided very useful and thorough data to enable the company’s board to make essential decisions regarding the business idea. As a result of the analysis, nothing material has changed in the objectives, concept and approach compared to the strategic plan we had prior to the feasibility analysis. However, the analysis has further strengthened the grounds for investing into the undertaking, and made such decision-making more robust; concluding that the HCP350 drug development project shall continue. The only adjustments include (i) more details have emerged for the clinical development plan, providing us with a series of different study designs that will be presented and discussed in the upcoming informal and formal scientific advice meetings; (ii) the regulatory affairs feasibility demonstrated that there are several ways to define the active substance, and that the way forward will depend very much on the mutual agreement with relevant regulatory authorities: mechanism of action theories will be investigated by measuring alterations in cytokine profiles, testing in a 3D psoriatic skin model; (iii) In order to reach the stage where a global licensing deal can be obtained with ‘big pharma’ partners, we will have to attract expertise, and several technical development partners and subcontractors, as well a number of potential marketing partners, were identified in the feasibility process.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

Overall, the feasibility study has confirmed that our initial idea is indeed feasible. The analysis has provided very useful and thorough data to enable the company’s board to make essential decisions regarding the business idea. Going from a business developing, marketing and selling dietary supplements to one that develops a pharmaceutical product (drug) is a huge step in terms of methodology and standards, as well as required documentation levels. Developing a drug will require very huge investments, in this case some further 45-50 m€, and the outcome is often binary: very huge profit if successful, but in case of (development failure), there is little value in the data themselves.
Consequently, as confirmed by the feasibility analysis, the HCP350 drug development project shall continue. As alluded to above, nothing material has changed in the objectives, concept and approach compared to the strategic plan we had prior to the feasibility analysis – however, the analysis has further strengthened the grounds for investing into the undertaking, and made such decision-making more robust.