Nitec Pharma Reports Positive Results For Phase III Lodotra Trail

Nitec Pharma (Nitec) has reported positive results from the second pivotal phase III trial for its lead 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, multicentre, double-blind phase III trial evaluating the safety and efficacy of Lodotra for the treatment of RA.

Reportedly, in total 350 patients, all inadequate responders to DMARD therapy, were randomised in one of two arms to receive either Lodotra (5mg once daily), or placebo in addition to their existing therapy.

The primary efficacy endpoint was the ACR-20 response rate, which is defined as at least a 20% improvement in a number of disease-specific criteria. The key secondary endpoint was the change in the duration of morning stiffness of the joints.

The study results demostrates that Lodotra treated patients showed an ACR-20 response of 49% compared to 29% in the placebo group. The difference was highly significant. The reduction of morning stiffness was 44% in the Lodotra group (21% in the placebo group). Lodotra was safe and well tolerated.

Anders Harfstrand, CEO of Nitec said: We are delighted to report successful and very positive outcomes of the CAPRA-2 study. These underline the benefits of Lodotra in the treatment of RA. 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 the successful European launches of Lodotra and the positive feedback that we have received from RA specialists, we look forward to completing the regulatory process in the US.