Switzerland's Nitec Pharma says its new rheumatoid arthritis drug Lodotra posted positive results in a second late-stage trial. And armed with a stack of trial data, the developer says it is now prepared to beat a path to the FDA next year with a New Drug Application.
Researchers aimed at a significant improvement in ACR20 scores--tracking a range of symptoms like tender joints--and found that 49 percent of the patients in the drug arm achieved ACR20 compared to 29 percent of the patients in the placebo group. Patients in the drug arm also posted a statistically significant reduction in morning stiffness compared to the subjects given a placebo.
"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," said Nitec CEO Dr. Anders Harfstrand. "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."
- check out Nitec's release