Nanocort demonstrates safety and good response in phase I/II trial for rheumatoid arthritis

Galapagos NV has announced that Nanocort has demonstrated safety as well as a faster and more pronounced decrease in rheumatoid arthritis disease symptoms compared to reference medication.

These results were obtained in an investigator driven double-blind, placebo controlled Phase I/II trial completed earlier this year at the Rheumatology Department of the Radboud University Nijmegen Medical Center in the Netherlands. The trial results will be further discussed during the "Late Breaking" poster presentation today at the 2008 American College of Rheumatology Annual Scientific Meeting in San Francisco. Galapagos in-licensed Nanocort from Enceladus in April 2008.

The Phase I/II trial enrolled 22 patients with active rheumatoid arthritis, and its purpose was to evaluate the safety of a single, intravenous administration of Nanocort. A secondary aim of the trial was to study the pharmacokinetics of this agent and compare the therapeutic effect of a single, intravenous dosage of Nanocort with that of a single intramuscular administration of an equipotent dose of the corticosteroid methylprednisolone acetate. The trial data demonstrated that Nanocort was well tolerated and had only limited adverse events. Although the study was not powered to show significant effects on clinical outcomes, patients receiving Nanocort showed faster and more pronounced decreases in disease symptoms. While therapeutic response was observed in both treatment groups, good response occurred only in patients receiving Nanocort.

"We are pleased that the Phase I/II trial results for Nanocort are presented at an important scientific meeting organized by the American College of Rheumatology, a stringent peer review body in this indication area. The investigators report that Nanocort demonstrated safety in this clinical trial, encouraging us to initiate further clinical trials to explore efficacy in chronic inflammatory disease areas. Based on the data presented by the investigators today, Galapagos is updating its future development plans for Nanocort," said Onno van de Stolpe, CEO of Galapagos.

The poster presentation, "Long-circulating Liposomal Prednisolone versus Pulse Intramuscular Methylprednisolone in Patients with Active Rheumatoid Arthritis" - Dr Pilar Barrera, principal investigator - L10, board #453, will be held by Bart Metselaar, CEO of Enceladus, at the 2008 American College of Rheumatology Annual Scientific Meeting in San Francisco today at 9 AM PST. The abstract, including data table, can be found online at www.rheumatology.org/annual, Abstracts, Search 2008, Advanced Search, type "Metselaar" in author name category.

Nanocort is a novel pharmaceutical for the treatment of RA flares and other inflammatory conditions requiring glucocorticoid therapy such as multiple sclerosis and inflammatory bowel disease. Nanocort is composed of prednisolone, a widely used corticosteroid enclosed in small lipid vesicles (liposomes). Glucocorticoids are a common treatment for RA and many other inflammatory disorders, but their use as a free drug is limited due to systemic side effects. In the Nanocort treatment, the glucocorticoid is largely confined to the liposome in the blood stream. After administration, the Nanocort liposomes selectively accumulate at sites of inflammation where they deliver long-lasting high concentrations of glucocorticoids. As a result, Nanocort may be able to significantly reduce frequency of administration and the toxicities of the glucocorticoid compared to other therapies.