Periodic Reporting for period 1 - NOTID (Novel treatment of inflammatory diseases)
Reporting period: 2016-12-01 to 2017-04-30
The overall objective is to develop a new biological candidate drug for safe and effective treatment of patients suffering from chronic inflammatory diseases, e.g. Rheumatoid Arthritis (RA). The approach is a therapeutic antibody that by a novel mechanism of action blocks the function of bile salt-stimulated lipase (BSSL), and thereby inhibits the inflammatory process and prevents joint destruction. The objective of the proposed innovation project as a whole (SME-instrument phase 1-3) is to plan, develop, secure and bring our innovation towards commercialization on the global market and to get to a Clinical Phase I proof of concept. In measurable terms we aim to document and reach the following results:
• A biological drug that passed toxicology and safety studies ready for Phase I clinical trials.
• A cell line for production of the biological drug.
• Provide a truely novel and complementary treatment to anti-TNFα and other biologicals.
• Offer a new mechanism that does not suppress the patients immune system.
• Inhibit and reverse the progress of the disease to minimise disability.
• Improve RA patients ability to work and reduce sick-leave.
• Reduce patients need for treatment at hospital.
Task 1 concerned the elaboration of a Drug Development Plan. This task included the evaluation of partners for production of a pre-candidate drug. The task also prepared for the design of the drug development. Task 2 elaborated a financial plan and included an investigation of different business models for financing of the exploitation phase. Task 3 elaborated a strategy for intellectual property rights.
The task also handled branding issues and the future communication strategy. Task 4 focused on a strategic evaluation of an orphan drug designation. Finally we put together the results from the first four tasks and produced an updated business innovation plan.
Results achieved include the elaboration of a Drug Development Plan (task 1). We have investigated and met potential partners for production, but we have not yet decided who the partner will be. We have several good candidates. We have elaborated a financial plan (task 2) which described the financial needs over a period of four years. In the current analysis of funding needs the total sum is €13 million to reach clinical proof of concept i.e. it has been tested in humans. We have filed for a divisional patent for Inflammatory Bowel Disease as a result of Task 3. We have increased our knowledge about orphan drug designation through dialogue and we have established a clinical plan for Juvenile Idiopathic Arthritis (JIA).
The wider societal implication is that more patients will be treated. Costs for treatment will decrease and unnecessary treatment can be avoided. Human suffering will decrease.