Biotech Values

[DewDiligence]

Update on GTCB’s U.S. ATryn program:

[From the CC in progress.]

GTCB has proposed that the pivotal U.S. ATryn trial have an active arm of 17 patients with hereditary antithrombin deficiency and an historical control arm of 35 patients. Assuming that the FDA goes along with GTCB’s proposed design, the active arm of the U.S. ATryn trial will be very similar to the European pivotal trial whose review is pending.

The proposed primary endpoint is the incidence of clinical symptoms of deep vein thrombosis (DVT) and other kinds of thromboembolism (as in the European trial). The active arm will contain both U.S. and European sites and is expected to take approximately one year to enroll.