PhaseBio Reports Fourth-Quarter and Full-Year 2020 Financial Results and Recent Business Highlights
PhaseBio Pharmaceuticals (Nasdaq: PHAS) released its financial results for Q4 and full-year 2020, highlighting major advancements in its therapeutic pipeline. The company is progressing with the Phase 3 REVERSE-IT trial for bentracimab, now enrolling over 60 patients towards a BLA submission. A commercial supply agreement with BioVectra supports further development. Looking ahead, PhaseBio aims to report Phase 2a data and an interim analysis in 2021, while also developing pemziviptadil for pulmonary arterial hypertension.
- Significant progress in Phase 3 REVERSE-IT trial for bentracimab, with over 60 patients enrolled.
- Commercial supply agreement with BioVectra to support bentracimab development.
- Accelerated enrollment expected to complete first 100 patients by mid-2021.
- BLA submission timeline for bentracimab could be impacted by COVID-19.
- Ongoing pandemic may affect patient enrollment strategies.
PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today reported financial results for the fourth-quarter and full-year ended December 31, 2020 and provided an update on clinical trial activities.
“Throughout 2020, PhaseBio made significant progress advancing our pipeline of therapies for serious cardiopulmonary diseases,” said Jonathan P. Mow, Chief Executive Officer of PhaseBio Pharmaceuticals. “Our progress was driven by the continued global expansion of the pivotal Phase 3 REVERSE-IT trial of our lead product candidate bentracimab, which has now enrolled more than half of the first 100 patients needed to support a BLA submission. We’ve generated this momentum by expanding the REVERSE-IT trial into Canada and the European Union, and we also recently announced a commercial supply agreement with BioVectra to support the continued development and eventual commercial supply of bentracimab, if approved.”
Mow continued, “Looking ahead into 2021, we are excited to continue advancing this pivotal program through key planned milestones including publishing Phase 2a data, announcing the interim analysis of the first 100 patients from the REVERSE-IT Phase 3 trial, initiating additional trial sites abroad, and working with key collaborators on our bentracimab commercialization plans. We also remain focused on advancing pemziviptadil for pulmonary arterial hypertension and are targeting to report Phase 2b data in the second half of 2021.”
Bentracimab (PB2452) Highlights
- Accelerated Enrollment in Ongoing REVERSE-IT Phase 3 Clinical Trial: As of March 2021, the REVERSE-IT Phase 3 clinical trial had enrolled 60 of the first approximately 100 patients needed to support a Biologics License Application (BLA), nearly all of whom to date have required urgent surgery or an invasive procedure. PhaseBio is attempting to accelerate enrollment of patients with uncontrolled major or life-threatening bleeding, including by working to increase the number of enrolling clinical trial sites in the United States, Canada, and the European Union as it is believed that a broader site footprint will increase the probability of enrolling these patients. All of the first approximately 100 patients enrolled in the REVERSE-IT trial will be measured against the same VerifyNow® PRUTest biomarker that is the primary endpoint for all patients enrolled in the REVERSE-IT trial. The trial is enrolling faster than PhaseBio originally projected, and PhaseBio now expects to complete enrollment of the first 100 patients in mid-2021 and is targeting to submit a BLA for bentracimab in mid-2022, although those timelines could be impacted by the continued scope and duration of the COVID-19 pandemic. Bentracimab is a novel, human monoclonal antibody fragment that in earlier clinical trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta® (ticagrelor).
