RheumArth SIGNED

Project "RheumArth" data sheet

The following table provides information about the project.

 Partnership

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Map

 Project objective

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 severe and life threatening. AP1189 is new chemically-synthesized small molecule drug for the treatment of Rheumatoid arthritis (RA). Through specific activation of the patients’ self-anti-inflammatory mechanisms, our first drug candidate renders unprecedent combination of safety, effectiveness and patient compliance, without the side effects associated with current therapies. The clinical validation of our drug for RA - 1st indication (foreseen for the Innovation Project) - will not only open a large market within this therapeutic area, as it will allow Synact to set a market foothold in the chronic inflammatory disease market, supporting the company´s medium term strategic positioning as an unique provider of a new generation of anti-inflammatory drugs. AP1189 clinical validation is on-going with current Phase I clinical trials showing promising preliminary results – safety and tolerance was proved in healthy human volunteers. Next step in the development will be a Phase IIa Proof-Of-Concept (POC) trail to validate our drug´s efficacy profile in RA patients. In this context, the present Phase 1 will be of utmost importance to validate AP1189´s market position and potential in RA and prepare the large clinical validation aimed for in the ensuing SME Instrument Phase II project.