Phase II clinical study to evaluate Nanocort commenced

Nov 17 2009

Galapagos NV (Euronext: GLPG) announced today that it has started a Phase II clinical study to evaluate Nanocort's effectiveness in treating flares in multiple sclerosis (MS). Nanocort combines less frequent treatment with lower dosage and potentially more effective delivery than other MS flare treatments.

Nanocort is a novel pharmaceutical for the treatment of inflammatory conditions such as MS and rheumatoid arthritis. The Phase II trial will involve 90 MS patients experiencing flares, episodes of increased neurological dysfunction. In the study, a single administration of Nanocort will be compared to the standard steroid treatment of three methylprednisolone infusions, with the aim to evaluate the efficacy and safety of Nanocort in treating MS flares. This study will take place in Belgium and Germany over a period of one to two years, with an interim readout after treatment of the first 20 patients.

This Phase II trial follows a Phase I/II study concluded in 2008, which demonstrated safety as well as faster and more pronounced decrease in rheumatoid arthritis flare symptoms as compared to standard steroid treatments. Since the completion of the Phase I/II study, the production and formulation were optimized in preparation for the Phase II studies. In the first half of 2010 Galapagos plans to initiate a small Phase II study to measure targeting of Nanocort to the inflamed joints of RA patients.

"After the positive outcome of the Phase I/II study last year, we have evaluated Nanocort's product profile and decided to pursue MS as a first indication. Pre-clinical studies indicate Nanocort's efficacy, and the product shows distinct advantages over conventional corticosteroid use," said Onno van de Stolpe, CEO of Galapagos. "We are proud that the start of this trial marks Galapagos' entry into Phase II studies, and the third program in clinical trials this year."