Periodic Reporting for period 1 - RheumArth (New drug for the treatment of rheumatoid arthritis)
Periodo di rendicontazione: 2018-05-01 al 2018-09-30
Rheumatoid arthritis (RA) is a chronic autoimmune disorder causing inflammation and permanent damage in joints and surrounding tissues - leading to severe disability, decreased quality of life, and reduced life expectancy. The disease affects more than 6 million people with annual costs amounting to €45billion in the Europe (EU) alone. There is a wide range of drug therapies for RA, mobilizing a variety of anti-inflammatory and immune modulating effects. However, a significant proportion (30%) of the patients do not respond to current treatments, efficacy is often reduced over time and the incidence of side effects is high and can be quite severe. With the RheumArth project, we seek to further develop a novel RA therapy: AP1189 - a safe and convenient, once-daily oral drug based on new and exciting scientific insights. Through selective activation of anti-inflammatory mechanisms that halt injury and induce repair of inflamed joints, our novel, oral drug candidate provides an unprecedented combination of safety, effectiveness and patient compliance without the side effects.
The SME Instrument Phase 1 project allowed Synact to refine the market landscape analysis, evaluate the value proposition of A1189 against market needs, validate the clinical and regulatory strategy for further development and update Synact’s business plan. The study allowed also Synact to plan the Phase IIa clinical validation, including engagement with stakeholders.
Conclusions of the Feasibility Study support our willingness to proceed with the clinical validation of AP1189 as we see a clear unmet need in the market for a drug with AP1189´s features. The study reinforced AP1189’s business opportunity supported by the unmet medical needs for efficient RA treatment and the attractive market niche targeted by AP1189. Moreover, based on reported cases, the likelihood to identify an industrial partner for the project pending positive outcome in phase 2a is considered highly likely - and experience with similar cases showed that deals made at this stage reaches the highest value. Furthermore, promising safety and tolerance results were obtained during Phase I clinical trials, and the next step in the clinical development will be a Phase IIa trial to validate our drug´s efficacy profile in RA patients. This will be complemented by intensive business development activities to maximize dialogues with potential future acquirers of AP1189. Positive Phase IIa data will enable an attractive licensing deal and secure the further development and commercialization of AP1189, allowing Synact to gain a market foothold in the chronic inflammatory disease market, and supporting the company´s medium term strategic positioning as a unique provider of a new generation of anti-inflammatory drugs.