FDA accepts Nitec's Lodotra IND

Switzerland-based Nitec Pharma AG says that the US Food and Drug Administration has accepted an Investigational New Drug application that seeks approval for the initiation of clinical trials of Lodotra, a developmental circadian cytokine modulator for the treatment of rheumatoid arthritis. Anders Harfstrand, the company's chief executive, said: "it was always [Nitec's] intention to conduct the appropriate trials in the USA and to further elucidate the additional benefits which Lodotra can bring to RA patients.

The news follows positive results from the European Phase III CAPRA-1 trial, which formed the basis of its submission to the European Medicines Agency (EMEA; Marketletter October 9, 2006). Nitec said that it plans to initiate a second Phase III trial of the drug in 2008 that will include 300 patients from the USA and Europe.