March 19, 2019
PhaseBio Reports Full Results from Phase 1 Clinical Trial
PhaseBio Pharmaceuticals, Inc. (NASDAQ: PHAS) announced today that results from their Phase 1 clinical trial of PB2452, a novel reversal agent for the antiplatelet drug ticagrelor, demonstrated that PB2452 provided immediate and sustained reversal of ticagrelor antiplatelet effects without report of drug-related serious adverse events.
The results were published online in the New England Journal of Medicine (NEJM) in a paper titled, “An Antibody-Based Ticagrelor Reversal Agent in Normal Volunteers” and were presented by Deepak Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and professor at Harvard Medical School, in a featured clinical research session at the American College of Cardiology’s 68th Annual Scientific Session (ACC.19) in New Orleans.
“Patients taking ticagrelor to reduce the risk of a cardiac event are currently without an effective method to reverse its antiplatelet effects, which increases the risk of spontaneous major bleeding and can quickly produce life-threatening bleeding should they require emergency surgery,” said Dr. Bhatt. “The results from the Phase 1 trial demonstrate that intravenous PB2452 provided immediate and sustained reversal of ticagrelor antiplatelet activity, thereby potentially reducing the bleeding risk associated with ticagrelor. The data support further evaluation of PB2452 for the reversal of the antiplatelet effects of ticagrelor in emergency situations involving major bleeding and to enable emergent or urgent surgery in patients.”
The first-in-human, randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluated the safety, efficacy and pharmacokinetics of intravenous PB2452 as a ticagrelor reversal agent in healthy volunteers. Sixty-four volunteers aged 18 to 50 years received either PB2452 or placebo. Ten sequential cohorts evaluated doses of PB2452 ranging from 0.1 to 18 grams (g) of PB2452. Cohorts one to three assessed doses of 0.1, 0.3 and 1.0 g of PB2452 infused for 30 minutes in the absence of ticagrelor pretreatment to assess initial safety. Cohorts four to six received 30-minute infusions of 1.0, 3.0 and 9.0 g of PB2452 or placebo following ticagrelor pretreatment for 48 hours. Cohorts seven to ten received an 18 g fixed dose of PB2452 or placebo through various infusion regimens. PB2452 demonstrated dose-linear increases in mean exposure across the dose range. Platelet function was assessed using light transmission aggregometry, a point-of-care P2Y12 platelet-reactivity test, and vasodilator stimulated phosphoprotein (VASP) assays.
[Originally posted by StreetInsider — March 18, 2019]