Pfizer's PCSK9 mAb meets in Phase III

Pfizer Inc. (NYSE:PFE) said its subcutaneous PCSK9 mAb, bococizumab ( PF-4950615), met the co-primary endpoints in the Phase III SPIRE-AI trial in patients with hyperlipidemia or mixed dyslipidemia receiving a statin. The pharma did not disclose details, but said the co-primary endpoints were the percent change from baseline in fasting LDL-C at week 12, and the delivery system success rate.

Patients in the trial received 75 or 150 mg subcutaneous bococizumab every two weeks via a pre-filled autoinjector pen, or placebo. The double-blind trial enrolled 299 patients with an LDL-C of at least 70 mg/dL on background statin treatment. ...