William Blair upgraded Akari Therapeutics (NASDAQ:AKTX) to “outperform” from “market perform” after the company announced that, following its end-of-Phase-2 meeting with the FDA, it is advancing Coversin for the treatment of paroxysmal nocturnal hemoglobinuria into two Phase 3 trials – ASSET and CAPSTONE – both of which are set to begin during the first quarter of 2018.
Shares of Akari closed at $8.74 on Sept. 21.
Analyst Tim Lugo writes that one key point from the announcement was that the FDA would allow the company to use a co-primary endpoint based on hemoglobin levels and transfusion rate data. While LDH levels will likely also be assessed, they will not drive the primary endpoint.
“We note that this is significant as the LDH levels observed in the admittedly small, four-patient Phase 2 readout, while positive, suggested improvement tracking slightly behind that of Soliris and ALXN1210, whereas transfusion freedom and hemoglobin level measurement data points were much more impressive (no transfusions required while on treatment),” he added.
Akari has suggested that slightly lower LDH improvement may be attributed to lower Coversin dosing, which may be improved with dosing in patients increased to 45 mg from 30 mg, or just a result of the small patient numbers studied, Mr. Lugo said.
