Scios' oral cytokine inhibitor to start Ph II

Scios will start Phase II trials of an orally-active cytokineinhibitor, SCIO-469, in rheumatoid arthritis patients in the second half of this year, following encouraging results from a Phase Ib trial. Preclinical evaluations suggest that the drug inhibits p38 MAP kinase, a stimulatory modulator of pro-inflammatory cytokines including tumor necrosis factor-alpha, interleukin-1 and cyclo-oxygenase-2, all of which are known to contribute to both symptoms and disease progression in patients with RA.

Scios notes that, in contrast to current protein-based treatments for RA based on anti-TNF activity, SCIO-469 offers more convenient dosing (oral administration versus injection or infusion), and may also provide additional therapeutic efficacy through its actions on IL-1 and COX-2. At the moment, there are two anti-TNF products on the market, Immunex/American Home Products' Enbrel (etanercept) and Johnson & Johnson's Remicade (infliximab), and both have been shown to markedly relieve the symptoms and retard the progression of RA.

In its Phase Ib trial, Scios demonstrated that SCIO-469 has good oral bioavailability and plasma pharmacokinetics, and was well-tolerated at a range of doses in healthy volunteers over a two-week dosing period.