TA101-GOCLIN

Clinical development of TA-101 for the treatment of rheumatoid arthritis

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 Obiettivo del progetto (Objective)

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 MyLife Technologies, 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.

Introduzione (Teaser)

Rheumatoid arthritis (RA) is a debilitating condition that requires innovative therapeutic strategies. A European consortium is working towards this goal by bringing a novel drug to the clinic.

Descrizione progetto (Article)

RA is associated with ageing and increasing life expectancy is bound to cause a heavy socioeconomic burden. This disease causes severe pain and discomfort, often preventing patients from working. As a result, novel therapies are urgently required for RA patients.

TA101 is a small domain antibody that is being developed for the treatment of RA. Pre-clinical evaluation has indicated significant efficacy and the drug now needs to be evaluated in clinical studies. The EU-funded http://ta101goclin.wordpress.com/ (TA101-GOCLIN) (Clinical development of TA-101 for the treatment of rheumatoid arthritis) project aims to take TA101 through to clinical development and perform safety studies in humans.

Partners are proposing the use of micro-needle patches as a method of autonomous administration of the drug through the skin without the pain of conventional injections. In addition, drug administration could be performed from their home without the need for hospitalisation. The project brings under its umbrella three small- and medium-sized enterprises to devise clinical drug production techniques, produce the micro-needle device and perform the clinical trial.

During the first part of the study, researchers optimised the expression parameters for the drug (plasmid and host) as well as the fermentation conditions and purification method. Significant progress has also been made with respect to the design and manufacture of the micro-needle device.

The global multi-billion market for arthritis drugs is constantly growing. Inhibitors of TNF? and non-steroid anti-inflammatory drugs generate huge sales globally. Novel pharmaceutical products such as the TA101 stand a good chance at entering the market and succeeding as a valid RA therapeutic.