Safety and interim antibody data from the current phase III study highlighted the definitive and significant dose response observed between the 100mg, 300mg and 900mg doses of Riquent compared with placebo, the company said. The second study reviewed the safety and drug levels of Riquent at doses up to 2400mg in healthy volunteers and the third, cardiovascular safety in healthy volunteers.
Deirdre Gillespie, president and CEO of La Jolla, said: “Unlike other medications currently used to treat lupus that can severely suppress the immune system and can result in serious infections, Riquent is highly specific and designed not to suppress the healthy functions of the immune system.
“We believe that Riquent has the potential to be highly efficacious and well-tolerated – it is designed to specifically target and reduce antibodies to double-stranded DNA that are believed to cause lupus renal disease.”
In the first study, the reductions in median antibody levels between the Riquent treatment groups and the placebo treatment group at week 8 were 100 mg: 30%; 300 mg: 40%; 900 mg: 58%. La Jolla said that the adverse event profile for these doses did not appear to differ from previous studies, where only 100 mg of Riquent was the treatment dose.
In the second study, Riquent at doses up to 2400mg in healthy male and female volunteers was well tolerated at all doses, while in the third study which examined cardiovascular safety in healthy volunteers, Riquent was well tolerated and the incidence of adverse events was similar in the placebo, 100 mg and 300 mg groups. In addition, patients exhibited no serious adverse events, and no subject discontinued the study.