Sierra Oncology Inc (NASDAQ:SRRA) unveiled topline data for momelotinib in myelofibrosis patients who are symptomatic, anemic, and previously treated with an FDA-approved JAK inhibitor.
With the new data in hand, Sierra now plans to submit a marketing application in Q2 FY22. In the Phase 3 study, 195 patients were randomized to receive either momelotinib or the control drug (danazol) for 24 weeks.
Sierra observed a reduction in disease symptoms in 25% of active arm patients, compared to just 9% in the control group.
The study also met the secondary endpoints, transfusion independence rate at least 12 weeks after the treatment period, and splenic volume reduction of at least 35% at Week 24.
Sierra said it saw 31% of patients meet the necessary independence threshold in the active arm compared to 20% in control.
23% of drug arm patients got to the necessary splenic reduction level against just 3% in control.
Momelotinib appeared to cause fewer serious side effects.
Sierra researchers saw Grade 3 or worse events in 54% of patients taking the drug compared to 65% in the control arm.
Additionally, 35% of the active arm saw a serious treatment-emergent side effect, compared to 40% in control.
SRRA added it has entered into a term loan agreement with Oxford Finance, designed to primarily support the commercial preparation and potential launch of momelotinib, an investigational agent for the treatment of myelofibrosis, a rare form of blood cancer.
SRRA shares popped $7.31, or 47.1%, at $22.82 first thing Tuesday.
