La Jolla Pharmaceutical Co of San Diego, California, announced that new analyses of existing clinical trial data provide support for Riquent® (abetimus sodium) for the treatment of lupus renal disease. Riquent was shown to significantly reduce antibodies to dsDNA in phase II/III and phase III trials.
The new analyses, presented at the 69th Annual Meeting of the American College of Rheumatology (ACR) in San Diego, demonstrate that controlling antibodies to dsDNA for longer periods of time results in a greater reduction in risk of renal flare in patients with lupus renal disease. The analyses focused on "minimal" responders, patients who had any reduction of antibodies to dsDNA below baseline for at least 50% of measured values. The frequency of renal flares was significantly lower in the minimal responders in phase II/III and phase III studies at 5.5% and 5.5%, respectively, compared with nonresponders at 27.8% and 26.5%, respectively (P <.0001 for each study). There were 58.2% minimal responders in the phase II/III trial and 60.7% in the phase III trial.
The company also presented positive preclinical results at the ACR meeting for its potent (IC50 <35 nM), selective, orally available small-molecule inhibitors of both the enzymatic and adhesive functions of membrane-associated semicarbazide-sensitive amine oxidase (SSAO, also known as vascular adhesion protein-1 or VAP-1), an inflammation-inducible, endothelial cell adhesion molecule that mediates binding between leukocytes and activated endothelial cells.
The data show that small-molecule inhibitors of SSAO provide clinical benefit in animal models of rheumatoid arthritis, inflammatory bowel disease (oxazalone-induced ulcerative colitis), multiple sclerosis (relapsing experimental autoimmune encephalomyelitis), and stroke. Improved clinical scores were observed in these models whether the compounds were administered prior to the onset of disease or during active disease.
—A. Techman