TA101-GOCLIN is a European project funded with the support of the Seventh Framework-Programme for Research and Technology Development.
The aim of TA101GOCLIN Project is to take TA101 into the clinical stage of development for rheumatoid arthritis and prepare the product for a novel mode of administration in the market of biologic therapeutics.
Rheumatoid Arthritis is still today a debilitating disease with an unmet medical need for effective and reasonably priced treatments despite much effort to cure or control the disease.
TA101 is a small domain antibody that is being developed for the treatment of rheumatoid arthritis and has passed through preclinical efficacy studies with much success. TA101 will now undergo an upscaling process of production to enter clinical trials. TA101GOCLIN project is within the scope of the clinical development of TA101 and is aimed at providing safety data in humans through a clinical trial of Phase Ia and Ib. Concomitantly, TA101GOCLIN will develop a novel mode of administration for TA101 to be used after project end. This will provide a major competitive advantage for the product already during development stages. The innovative administration will use microneedle patches, a new method that allows the autonomous administration of the drug through the skin without the pain of conventional injections.
To achieve the above mentioned objectives, TA101GOCLIN gathered three competitive SMEs from Portugal, Belgium and The Netherlands. TechnoPhage, Q-Biologicals and Amspar, respectively, will be responsible for developing the clinical data of Phase I for TA101, develop an upscale method for production of the drug, and develop the microneedle device for administration of TA101. Overall, TA101GOCLIN holds the promise that an innovative product for the treatment of Rheumatoid Arthritis will enter the clinical phases of development with the confidence that the technologies that are at its base will create a new solution for the patients, with the major benefits of efficacy, safety, convenience and affordability.
The workplan of the TA101 GOCLIN project is organized in six working packages (WP) as follows:
WP1 – Process development of TA101 in cGMP conditions.
WP2 – Clinical research of Phase I.
WP3 – Development of a medical device for the optimal administration of TA101 (micro-needle patches)
WP4 – Dissemination and training.
WP5 – IP management.
WP6 – Project management.
These WP’s wil pursue several key objectives of the projects overall strategy, namely:
1) Generate an efficient method for the production of TA101 for clinical studies;
2) Perform clinical studies of Phase I (safety studies in healthy volunteers);
3) Develop an innovative solution for the efficient and simplified mode of administration for TA101.
At the end o this work plan TA101 will finally be ready for Proof-of-Concept studies (Phase IIa) in patients with rheumatoid arthritis.
More on working packages, click here.