Lexicon has initiated a phase 2 clinical trial of LX2931 in patients with rheumatoid arthritis. The company has also completed a drug-drug interaction (DDI) study of LX2931 with methotrexate in patients with rheumatoid arthritis, with no clinically significant drug-drug interactions observed.
LX2931 inhibits sphingosine-1-phosphate (S1P) lyase, an enzyme identified by Lexicon scientists as a promising new target on a pathway associated with regulation of the human immune system.
The phase 2 clinical trial is designed as a 12-week, randomized, double-blind, placebo-controlled study, to evaluate the safety and tolerability of LX2931 and its effects on symptoms associated with rheumatoid arthritis.
The study will include multiple centers in the US and Eastern Europe. The company expects to enroll up to 120 patients with rheumatoid arthritis on stable methotrexate therapy.
Reportedly, three dose levels will be evaluated: a 70mg dose, a 110mg dose and a 150mg dose, each administered once daily.
The primary endpoint will be the ACR20, as a 20% improvement in symptoms associated with rheumatoid arthritis. Multiple secondary endpoints will also be evaluated, including ACR50, ACR70, and DAS28.
Philip Brown, senior vice president of clinical development at Lexicon, said: We believe that, as an oral therapy, LX2931 could have advantages over current biologic therapies in treating patients with rheumatoid arthritis. LX2931 has demonstrated potent anti-inflammatory activity in preclinical models of arthritis and inflammation and, importantly, has been well tolerated in combination with methotrexate, the current standard of care first-line therapy.