New drug for the treatment of rheumatoid arthritis

Información del proyecto

RheumArth

Identificador del acuerdo de subvención: 816358

DOI

10.3030/816358

Proyecto cerrado

Fecha de la firma de la CE 9 Mayo 2018

Fecha de inicio 1 Mayo 2018

Fecha de finalización 30 Septiembre 2018

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

SYNACT PHARMA APS
Denmark

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

Período documentado: 2018-05-01 hasta 2018-09-30

Resumen del contexto y de los objetivos generales del proyecto

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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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