New drug for the treatment of rheumatoid arthritis

Project Information

RheumArth

Grant agreement ID: 816358

DOI

10.3030/816358

Project closed

EC signature date 9 May 2018

Start date 1 May 2018

End date 30 September 2018

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

SYNACT PHARMA APS
Denmark

Periodic Reporting for period 1 - RheumArth (New drug for the treatment of rheumatoid arthritis)

Reporting period: 2018-05-01 to 2018-09-30

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

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.

AP1189 Mode of action