PhaseBio Pharmaceuticals, Inc. announced the completion of a successful Type B pre-biologics license application (pre-BLA) meeting with the U.S. Food and Drug Administration (FDA) for bentracimab, a recombinant, human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of ticagrelor in patients presenting with uncontrolled bleeding or in need of surgery. Based on this pre-BLA meeting and the formal written minutes received from the FDA, PhaseBio intends to submit the BLA for bentracimab by early in the fourth quarter of 2022. During the pre-BLA meeting, the FDA agreed that the company's plans to submit a BLA with data from 25-30 patients with uncontrolled bleeding, together with data from the fully completed surgical cohort, appeared reasonable to support a label with both bleeding and surgical indications but would be a review issue based on the data submitted.

To date, and subject to final adjudication, the REVERSE-IT trial has enrolled 35 patients taking ticagrelor who experienced uncontrolled bleeding events. PhaseBio previously intended to base its BLA submission on data from the interim analysis of the Phase 3 REVERSE-IT trial published in December 2021, and the recently presented Phase 2b trial data. Based on the feedback received from the FDA during the pre-BLA meeting, PhaseBio will include in the BLA submission the additional bleeding patients who have enrolled in the REVERSE-IT trial since the pre-specified interim analysis was completed to support a potential bleeding indication.

In addition to discussing the potential allowance of additional bleeding patients into the BLA submission, the FDA also noted that, if during the review process the application was deemed adequate to support approval for only one of the two requested indications, the agency would consider separating and allowing for possible Accelerated Approval of only one of the two indications. For post-marketing requirements, the FDA confirmed its prior recommendation that the company complete enrollment in the Phase 3 REVERSE-IT trial and submit data from a total of at least 200 patients from this trial, and establish a post-approval registry study that will be active ahead of a product launch following potential Accelerated Approval. PhaseBio plans to continue to enroll patients for the bleeding population to complete the post-approval requirement of completing the REVERSE-IT trial.

Bentracimab has been studied in completed Phase 1 and Phase 2 clinical trials and has demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of the antiplatelet activity of ticagrelor, potentially mitigating concerns regarding bleeding risks associated with the use of this antiplatelet drug.