I posted the information below on Investors Hub. Do you feel this is an accurate assessment of the efficacy of the Phase II RA trial data for R788?:
In the 100 mg twice/daily dose, which is the likely dose to be carried forward (RIGL will test 150mg once/daily), 65% of patients attained an ACR20 (meaning 65% of patients reported a 20% improvement in their RA symptoms), 49% of patients attained an ACR50, and 33% attained an ACR70. However, just 38%, 19%, and 4% of placebo patients, respectively, attained ACR20, ACR50, and ACR70. The results were statistically significant.
The aforementioned results are the pooled results from U.S. and Mexico patients. The numbers are admittedly a little skewed due to the significantly better results reported in Mexico. Specifically, those ACR20, ACR50, and ACR70 scores in Mexican patients at 100mg were 75%, 64%, and 46%, respectively. However, even if you just isolate the U.S. results, they are much better than placebo and statistically significant at ACR20, ACR50, and ACR70 scores of 52%, 29%, and 14%, respectively. Enbrel, by contrast, has demonstrated ACR20, ACR50, and ACR70 scores of 66%, 42%, and 15%, respectively.
So, the drug clearly showed activity in this Phase II trial. The robustness of that activity depends on how you view the results. If you just look at the U.S. patients, then the ACR scores appear to be a bit lower than Enbrel although the ACR70 score is almost a dead heat. If you take into account all patients, then R788 had an essentially equivalent ACR20 score but a much more robust ACR50 and ACR70 score than Enbrel. Of course R788 is an oral drug too which should offer a big advantage. |
