PhaseBio Highlights Real-World Healthcare Cost and Bleeding Cost Data Featured at the International Society for Pharmacoeconomic and Outcomes Research (ISPOR) Virtual 2021 Conference
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today highlighted a presentation of healthcare cost and bleeding cost data featured at the Virtual ISPOR 2021 Conference held from May 17-20, 2021.
The poster presentation summarized an analysis of the IBM (News - Alert)® MarketScan® Commercial and Medicare Supplemental claims databases and focused on patients newly initiating a P2Y12 inhibitor, factor Xa inhibitor or dabigatran between 2014 and 2018. All patients were required to present =1 year of continuous insurance coverage prior to initiating their therapy, and outcomes were measured while patients remained on therapy. Healthcare resource utilization measures focused on total healthcare costs, which were paid amounts from all medical and pharmacy claims, and bleed-related healthcare costs, which were paid amounts from all emergency room (ER) and inpatient (IP) hospital claims that included a diagnosis code for a bleed. Bleeding events included internal bleeds (gastrointestinal, intracranial, and other internal bleeding), external bleeds (trauma-related bleeds/amputations), and bleeding events related to medical procedures.
Results of the analyses demonstrated that, in the year prior to initiating therapy, total healthcare costs were higher among P2Y12 inhibitor patients compared to factor Xa and dabigatran patients. While on therapy, P2Y12 inhibitor patients in the commercial insurance group incurred similar total healthcare costs to factor Xa and dabigatran patients, while Medicare patients on P2Y12 inhibitor therapy incurred higher total healthcare costs than factor Xa and dabigatran patients.
The examination of costs associated with the management of bleeding events in the year prior to initiating therapy revealed that P2Y12 inhibitor patients incurred greater costs than both factor Xa patients and dabigatran patients. Costs to manage bleeding events while patients were taking their antithrombotic medication were similar across classes for both commercially-insured and Medicare patients.
These healthcare cost analyses among patients on antithrombotic medications build on separate analyses from a larger overall study that were recently presented at The American College of Cardiology's 70th Annual Scientific Session. The previously-presented analyses demonstrated that, when compared to patients using factor Xa inhibitors or dabigatran, patients prescribed P2Y12 inhibitors have a higher burden f comorbid conditions and are potentially more likely to experience a bleeding event while taking their medication. Taken together, these conference proceedings present compelling evidence of an unmet medical and pharmacoeconomic need for an effective reversal agent for patients treated with P2Y12 inhibitors.
Jonathan P. Mow, Chief Executive Officer of PhaseBio Pharmaceuticals stated, "This analysis of real-world cost data highlights that the economic burden related to bleeding events associated with P2Y12 inhibitors is similar to commonly prescribed anticoagulants such as factor Xa inhibitors and dabigatran. With reversal agents available to help manage bleeding risks in factor Xa inhibitor and dabigatran patients, physicians, hospital systems and managed care organizations are familiar with the potential benefits of being able to quickly restore hemostasis during uncontrolled bleeding events or prophylactically avert bleeding in urgent surgery situations." Mow continued, "The unmet need for a reversal agent for patients treated with P2Y12 inhibitors is clear, and we believe that bentracimab, if approved, has the potential to give patients and physicians an important option that could help better optimize the balance between managing thrombotic risk and bleeding risk."
About Bentracimab (PB2452)
Bentracimab is a novel, recombinant, human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations. In a Phase 1 clinical trial, bentracimab 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 this antiplatelet drug. The Phase 1 clinical trial of bentracimab in healthy volunteers was published in the New England Journal of Medicine in March 2019. In April 2019, bentracimab received Breakthrough Therapy Designation from the Food and Drug Administration (FDA). Breakthrough Therapy Designation may be granted by the FDA when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapy. In September 2019, PhaseBio completed a Phase 2a trial in which bentracimab was investigated in older and elderly subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin. Additionally, the Phase 2a trial investigated a bentracimab regimen for the reversal of supratherapeutic doses of ticagrelor in healthy younger subjects. In both arms of the trial, bentracimab achieved immediate and sustained reversal of the antiplatelet effects of ticagrelor and was generally well-tolerated, with only minor adverse events reported. These results are consistent with the results observed in healthy younger subjects treated with ticagrelor in the previously published Phase 1 trial. PhaseBio initiated the REVERSE-IT trial, a pivotal Phase 3 clinical trial of bentracimab, in March 2020 to support a Biologics License Application for bentracimab in both major bleeding and urgent 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 for cardiovascular and cardiopulmonary diseases. The company's pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly VIP receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including pemziviptadil, and drives both internal and partnership drug-development opportunities.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements.
Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.
Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC (News - Alert)") filings, including in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law.
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