Malvern, PA, and San Diego, CA, September 24, 2018 — PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for orphan diseases, with an initial focus on cardiopulmonary disorders, today announced positive preliminary results from a Phase 1 clinical trial of PB2452, a novel reversal agent for the antiplatelet drug ticagrelor.
The dose-escalation trial was designed to evaluate the safety and tolerability and determine proof of concept for PB2452 as a ticagrelor reversal agent in healthy subjects pre-dosed with ticagrelor. In the trial, PB2452 achieved rapid, complete and sustained reversal of ticagrelor’s antiplatelet activity with potential customizable duration of reversal based on the dosing regimen. There were no PB2452-related adverse events or serious adverse events reported.
“We are pleased that the preliminary results of the Phase 1 trial of PB2452 support continued development of PB2452 as a reversal agent for the antiplatelet effects of ticagrelor in patients who are experiencing a major bleeding event or require urgent surgery, which are areas of significant unmet need,” said John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. “The availability of a reversal agent such as PB2452 could uniquely position ticagrelor as the only oral antiplatelet drug with a reversal agent and expand its use by mitigating concerns regarding the bleeding risk associated with antiplatelet drugs. We look forward to presenting the full Phase 1 dataset at an upcoming medical meeting and plan to initiate a Phase 2a trial in healthy older adults the first half of 2019.”
PB2452 is a novel, recombinant, human monoclonal antibody antigen-binding fragment, or Fab fragment, designed to reverse the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations. In clinical and preclinical studies, PB2452 achieved rapid and complete reversal of ticagrelor’s antiplatelet activity, which has the potential to bring life-saving therapeutic benefit by increasing the safety of ticagrelor and mitigating concerns regarding the bleeding risk associated with antiplatelet drugs. There are currently no approved reversal agents for ticagrelor or any other antiplatelet drugs.
PhaseBio Pharmaceuticals, Inc., is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for the treatment of serious orphan diseases, with an initial focus on cardiopulmonary disorders. The company’s lead development candidate is PB2452, a novel reversal agent for the antiplatelet therapy ticagrelor. PhaseBio is also leveraging its proprietary ELP technology platform to develop therapies with the potential for less-frequent dosing and improved pharmacokinetics. PhaseBio’s second product candidate PB1046, which is based on ELP, is a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of PAH. PhaseBio is privately owned, with offices in Malvern, PA and San Diego, CA. For more information, please visit www.phasebio.com.
Laura Bagby, 6 Degrees