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PhaseBio Pharmaceuticals has voluntarily ended its Phase 2b trial of pemziviptadil for pulmonary arterial hypertension due to challenges posed by COVID-19, including impacts on manufacturing and enrollment rates. The company plans to evaluate existing trial data to determine next steps, which might involve simplifying product dosing. Resources will be redirected towards the commercialization of bentracimab and advancing other pipeline programs. The VIP trial had successfully enrolled over 50% of its target population before being halted.
PhaseBio Pharmaceuticals announced positive interim data from its pivotal Phase 3 trial, REVERSE-IT, for bentracimab, aimed at reversing antiplatelet effects of ticagrelor in urgent surgery and major bleeding cases. The trial achieved both primary and co-primary endpoints, demonstrating a strong clinical efficacy and a remarkable safety profile with no serious drug-related adverse events. PhaseBio plans to submit a Biologics License Application to the FDA in mid-2022, targeting urgent surgery and major bleeding indications.
PhaseBio Pharmaceuticals has appointed Jonathan J. Birchall as Chief Commercial Officer, enhancing its leadership as it prepares to launch bentracimab in the U.S., pending FDA approval. Birchall brings over 25 years of experience, notably from Genentech, where he led the thrombolytics franchise. The company's strategic plan includes submitting a Biologics License Agreement to the FDA by mid-2022, with hopes for the product's launch in early 2023. This move aims to address significant unmet needs in critical care related to platelet restoration.
PhaseBio Pharmaceuticals announced positive interim results from the REVERSE-IT Phase 3 clinical trial of bentracimab, aimed at reversing the antiplatelet effects of ticagrelor. The trial achieved its primary endpoint with a 135% reduction in platelet inhibition within 10 minutes of bentracimab infusion, and over 90% of patients reached good or excellent hemostasis. Bentracimab was well tolerated, with no drug-related serious adverse events reported. The results were presented at the AHA 2021 Scientific Sessions and will be published in NEJM Evidence. A BLA submission to the FDA is anticipated in mid-2022.
PhaseBio Pharmaceuticals (Nasdaq: PHAS) announced key updates on bentracimab, including topline data from its Phase 2b trial and achievement of an enrollment milestone for the Phase 3 REVERSE-IT trial. The Phase 2b trial showed successful reversal of ticagrelor's effects in older volunteers, supporting future BLA submission targeted for mid-2022. Financial results revealed a net loss of $31.9 million in Q3 2021, up from $25.1 million the previous year. Cash increased to $56.4 million due to stock offerings and milestone payments. Upcoming presentations at the AHA conference on November 15 will further detail bentracimab's efficacy.
PhaseBio Pharmaceuticals will present a prespecified interim analysis of the pivotal REVERSE-IT Phase 3 trial on November 15, 2021, during a late-breaking science session at the American Heart Association Scientific Sessions. The trial evaluates bentracimab for reversing the antiplatelet effects of ticagrelor in patients with uncontrolled major bleeding or those needing urgent surgery. Guest speakers include leading cardiologists and a Q&A session will follow the presentation. The webcast will be available for 60 days post-event.
PhaseBio Pharmaceuticals (NASDAQ: PHAS) announced positive topline results from its Phase 2b trial of bentracimab, achieving the primary efficacy endpoint of reversing ticagrelor’s antiplatelet effect in older volunteers. This trial involved 150 subjects receiving bentracimab and demonstrated a safety profile consistent with earlier trials. The company plans to present interim results from the ongoing REVERSE-IT Phase 3 trial on November 15, 2021, at the American Heart Association’s Scientific Sessions, marking a critical step toward potential regulatory approval.
PhaseBio Pharmaceuticals, Inc. (NASDAQ: PHAS) announced the acceptance of its pivotal Phase 3 trial, REVERSE-IT, for presentation at the American Heart Association's Scientific Sessions on November 15, 2021. The trial investigates the reversal of antiplatelet effects of ticagrelor with bentracimab in patients facing uncontrolled bleeding or requiring urgent surgery. Approximately 200 participants are targeted, with earlier results showing successful enrollment of 143 patients. Bentracimab aims to mitigate the bleeding risks associated with ticagrelor use.
PhaseBio Pharmaceuticals, Inc. (NASDAQ: PHAS) has appointed William D. Humphries to its board of directors, enhancing its leadership team. Humphries, with over 30 years in the pharmaceutical sector, brings significant commercial experience, notably as CEO of Isosceles Pharmaceuticals. He will aid in advancing PhaseBio's clinical programs and building a U.S. commercial organization for marketing bentracimab, a potential treatment pending FDA approval. Justin Klein, M.D., J.D., has stepped down as a director. The company continues to focus on developing therapies for cardiopulmonary diseases.
PhaseBio Pharmaceuticals, Inc. (NASDAQ: PHAS) announced that CFO John Sharp will present at the 23rd Annual H.C. Wainwright Global Investment Conference. The presentation will be accessible on demand starting at 7:00am ET on September 13, 2021. Interested viewers can find the live and archived webcast on the company’s website for 90 days post-event. PhaseBio focuses on novel therapies for cardiopulmonary diseases, including bentracimab, pemziviptadil, and PB6440, utilizing a proprietary elastin-like polypeptide technology platform.
