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Positive results for arthritis drug

Nitec Pharma, has announced positive results for Lodotra, for the treatment of rheumatoid arthritis

Swiss pharma company, Nitec Pharma, has announced positive results from the second pivotal phase III trial for its product, Lodotra, for the treatment of rheumatoid arthritis (RA).

The CAPRA-2 study (Circadian Administration of Prednisone in Rheumatoid Arthritis-2) was a 12-week, multi-centre, double-blind phase III trial. A total of 350 patients, all inadequate responders to DMARD therapy, received either Lodotra (5mg once daily), or a placebo, in addition to their existing therapy. The primary efficacy endpoint was the ACR-20 response rate (ie, at least a 20 per cent improvement in a number of disease-specific criteria). The key secondary endpoint was the change in the duration of morning stiffness of the joints.

CAPRA-2 data will be used to file for US marketing approval with the Food and Drug Administration (FDA), together with the data already available from the CAPRA-1 pivotal phase III trial, which showed the superiority of Lodotra over standard prednisone treatment.

Lodotra-treated patients showed an ACR-20 response of 49 per cent, compared to 29 per cent in the placebo group. The difference was highly significant. The reduction of morning stiffness was 44 per cent in the Lodotra group, compared to 21 per cent in the placebo group. This difference was also highly significant. The treatment was safe and well tolerated, with the number of adverse events low and comparable in both groups.

Dr Anders Harfstrand, CEO of Nitec, commented: "The study confirms clearly that the innovative delivery system of Lodotra is able to adapt the timing of glucocorticoid treatment to a patient's circadian rhythm in order to improve the efficacy and safety of prednisone. CAPRA-2 is the first pivotal phase III study to demonstrate the ACR-20 response of a very low dose of prednisone as a primary endpoint."

Following successful European launches of Lodotra, the company will move to complete the regulatory process in the US.

2nd September 2009

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