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.)
Période du rapport: 2019-08-01 au 2020-01-31
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.
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.
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.