PhaseBio Enters Worldwide License Agreement with MedImmune for a Reversal Agent for Ticagrelor

• First-in-class and unique reversal agent for ticagrelor aims to address important unmet need for patients requiring antiplatelet therapy
• Potential for accelerated development timeline with Phase 1 initiation expected in 1H18
• License diversifies PhaseBio’s pipeline of orphan, cardiovascular-focused therapies

MALVERN, Pa, Nov. 28, 2017 -- PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing therapies for the treatment of orphan diseases, today announced that the Company has entered an exclusive, worldwide license agreement with MedImmune, the global biologics research and development arm of AstraZeneca, for PB2452 (formerly MEDI2452), a Phase 1-ready reversal agent for ticagrelor.

Ticagrelor is unique among P2Y₁₂ antagonist antiplatelet agents due to its ability to reversibly bind to the receptor, whereas other P2Y₁₂ antagonists bind permanently. Due to this unique mechanism of action, ticagrelor is the only oral antiplatelet with the potential to be reversed, should this be needed. PB2452 is an investigational, intravenous Fab antibody fragment designed to rapidly and specifically reverse the antiplatelet effects of ticagrelor in rare emergency situations. In preclinical studies, PB2452 demonstrated high affinity and specific binding to ticagrelor, and was shown to reverse ticagrelor-mediated inhibition of platelet aggregation and normalize bleeding.¹

“There is a clear need for treatments that reverse the effects of antiplatelet therapies in acute care situations, like urgent surgery or severe bleeding. PB2452’s compelling preclinical data support its potential to be a first-in-class reversal agent for ticagrelor. The profile of PB2452 and the planned development pathway fits nicely with PhaseBio’s niche focus on orphan cardiovascular disorders,” said Jonathan P. Mow, Chief Executive Officer of PhaseBio. “We are excited that MedImmune has chosen to partner with PhaseBio for this medically important asset, which also allows us to diversify our pipeline beyond our ELP technology platform. We plan to initiate a Phase 1 study in the first half of 2018.”

Cam Patterson, M.D., a cardiologist, Senior Vice President and Chief Operating Officer of New York-Presbyterian/Weill Cornell Medical Center, said, “PB2452 has the potential to reverse the antiplatelet effects of ticagrelor in rare emergency situations, while also reducing the current waiting period required ahead of emergency surgeries for patients on antiplatelet therapy.”

About PB2452 (MEDI2452)

PB2452 is a neutralising Fab antibody fragment that binds to ticagrelor and its active metabolite AR-C124910XX, and is intended to reverse the antiplatelet effects of ticagrelor. The availability of PB2452 would enable reversal of the antiplatelet effects of ticagrelor in rare emergency situations and greatly reduce the waiting period before surgery.

About PhaseBio

PhaseBio Pharmaceuticals, Inc., is a clinical-stage biopharmaceutical company developing therapies for the treatment of orphan diseases. PhaseBio is leveraging its proprietary elastin-like polypeptide (ELP) biopolymer technology platform to develop therapies with the potential for less-frequent dosing and better patient compliance. PhaseBio’s lead development candidate, PB1046, is a first-in-class weekly vasoactive intestinal peptide (VIP) receptor agonist for the treatment of pulmonary arterial hypertension (PAH). PhaseBio is privately owned, with headquarters and research laboratories in Malvern, PA. For more information, please visit www.phasebio.com.

About ticagrelor

Ticagrelor is a direct-acting P2Y₁₂ receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines. Ticagrelor works by inhibiting platelet activation and has been shown to reduce the rate of atherothrombotic cardiovascular (CV) events, such as heart attack or CV death, in patients with acute coronary syndromes (ACS).

Ticagrelor, co-administered with aspirin, also known as acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with ACS, or for patients with a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event.

¹ Buchanan A, Newton P, Pehrsson S, et al. Structural and functional characterization of a specific antidote for ticagrelor. Blood. 2015;125(22):3484-3490. doi:10.1182/blood-2015-01-622928.

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