7:36AM Rigel Pharma provides pipeline update; R333 did not meet the primary endpoint in a recently completed Phase 2 clinical study; co has decided not to pursue this indication further with R333 (RIGL) 3.54 : Co announced updates on two of its pipeline products: R333, a topical dermatological JAK/SYK inhibitor, and fostamatinib, an oral SYK inhibitor.
R333 Update
Rigel announced that R333, which was being evaluated as a potential therapeutic for active skin lesions in patients with discoid lupus erythematosus (DLE), did not meet the primary endpoint in a recently completed Phase 2 clinical study. The primary endpoint was the proportion of patients who achieved at least a 50% decrease from baseline in the total combined Erythema and Scaling score of all treated lesions at Week 4. R333 was shown to be relatively safe and well tolerated. In light of these overall findings, co has decided not to pursue this indication further with R333.
Fostamatinib Update
Rigel representatives met with the FDA for an end-of-Phase 2 meeting for fostamatinib, an oral SYK inhibitor in development for patients with immune thrombocytopenic purpura (ITP). Rigel expects to initiate two pivotal Phase 3 studies in the first half of 2014. Each of these trials are expected to enroll ~ 75 patients who would be treated for six months and have the option to enroll in an extension study. These trials will be randomized, placebo-controlled and will enroll verified ITP patients with platelet counts below 30,000 platelets per microliter of blood. The goal of the trials will be to achieve a durable platelet count increase to over 50,000 platelets per microliter of blood. Rigel expects top line data from these studies in 2015.
