MALVERN, Pa. and SAN DIEGO, Aug. 26, 2019 (GLOBE NEWSWIRE) -- PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for orphan diseases, today announced that pharmacodynamic data from the Phase 1 clinical trial of PB2452, a novel reversal agent for the antiplatelet drug ticagrelor, have been selected for oral presentation at ESC Congress 2019, being held August 31 - September 4, 2019, at the Expo Porte de Versailles in Paris, France.
Presentation details are as follows:
Title: Evaluation of the Pharmacodynamics of a Ticagrelor Reversal Agent PB2452
Session: New Developments in Anti-Thrombotic Drug Therapy
Date / Time: Sunday, September 1, 17:32 - 17:50 GMT/ 11:32 – 11:50 AM EDT
Location: Reykjavik - Village 2
Presenter: Lisa K. Jennings, Ph.D., University of Tennessee Health Science Center
Additional information can be found on the ESC Congress website here.
PB2452 is a novel, recombinant, human monoclonal antibody antigen-binding fragment, or Fab, designed to reverse the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations. In a Phase 1 clinical trial, PB2452 demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of ticagrelor’s antiplatelet activity, mitigating concerns regarding bleeding risks associated with the use of antiplatelet drugs. The Phase 1 clinical trial of PB2452 in healthy volunteers was published in the New England Journal of Medicinein March 2019.1 In April 2019, PB2452 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (“FDA”). Breakthrough Designation may be granted by FDA when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapy. In the first quarter of 2020, PhaseBio plans to initiate a single pivotal Phase 3 clinical trial of PB2452 which will support a Biologics License Application for both major bleeding and surgery indications. 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 to treat 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 elastin-like polypeptide (“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 pulmonary arterial hypertension.
PhaseBio is located in Malvern, PA and San Diego, CA. For more information, please visit www.phasebio.com.
PhaseBio Pharmaceuticals, Inc.
Chief Financial Officer
- Bhatt DL, Pollack CV, Weitz JI, et al. Antibody-Based Ticagrelor Reversal Agent in Healthy Volunteers. N Engl J Med 2019;Mar 17.
Source: PhaseBio Pharmaceuticals, Inc.