Replies to post #119024 on Biotech Values

[jq1234]

ORAL Standard is a completed twelve-month study in patients with moderate-to-severe active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX) and were randomized to receive tofacitinib 5 or 10 mg BID, adalimumab 40 mg subcutaneously every other week or placebo, each of which was added to stable background MTX.

The ORAL Standard study met all primary endpoints at the 5 and 10 mg BID doses of tofacitinib, showing statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates at six months; in improving physical function, as measured by mean change in HAQ DI at three months; and in reaching DAS28-4(ESR) <2.6 at six months.

Didn't mention anything on how Humira arm was doing.

ORAL Step is a completed six-month study in patients with moderate-to-severe active RA who had an inadequate response to a TNF inhibitor and were randomized to receive tofacitinib 5 or 10 mg BID or placebo, which were added to stable background MTX.

The ORAL Step study met all primary endpoints at the 5 and 10 mg BID doses, showing statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates; in improving physical function, as measured by mean change in HAQ DI; and in reaching DAS28-4(ESR) <2.6, all assessed at three months.

This is very good efficacy result, better than I expected. Maybe PFE can file NDA this year.

[DewDiligence]

Data from the three phase-3 Tofacitinib trials that have not already been discussed in a peer-reviewed forum—Oral Standard, Oral Step, and Oral Scan—will be presented at the ACR conference in November. The other two phase-3 Tofcitinib trials that will be included in the NDA submission are called Oral Solo and Oral Sync.

Please see the prologue of #msg-62546621 for a scorecard of the five pivotal trials in this program.