Vasoactive intestinal peptide(SkyePharma Plc)

PhaseBio Chief Executive Officer Jonathan Mow/Courtesy PhaseBio Pharmaceuticals A pipeline pivot from type 2 diabetes to cardiovascular disease appears to be paying off for PhaseBio Pharmaceuticals. Weeks after unveiling positive Phase IIb data, the company announced positive interim Phase III data demonstrating lead product candidate bentracimab’s ability to reverse the antiplatelet effects of AstraZeneca’s blood-thinner Brilinta. The REVERSE-IT Phase III data, presented at the American Heart Association’s 2021 Scientific Sessions, shows that bentracimab hit the mark with immediate and sustainable reversal of the bleeding effects of Brilinta (ticagrelor) on patients who require an urgent surgery, an invasive procedure, or experience uncontrolled bleeding that could become life-threatening. Data from the study shows a 135% reduction in platelet inhibition within five to 10 minutes and sustained for a 24 hour period, PhaseBio Chief Executive Officer Jonathan Mow told BioSpace in an exclusive interview. “We’re really excited about what we’ve been seeing,” Mow said. When PhaseBio pivoted from the type 2 diabetes market, the company sought to enter the cardiovascular space, with a focus on indications that did not have significant competition. The company put together a product profile. They explored various assets and found what they were looking for in bentracimab, which had been in development by AstraZeneca as a complementary drug for Brilinta, a direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation. Bentracimab is a novel, recombinant, human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of Brilinta in major bleeding and urgent surgery situations. Brilinta has been approved for use in more than 100 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome, or as a preventative drug for patients who are at high-risk and have experienced a heart attack. Mow said bentracimab checked all the boxes on the company’s list. What’s more, he said they realized that a study in healthy volunteers would be highly predictive of the medication’s potential in late-stage studies with patients in need. And, that realization has held up through Phase I and Phase II tests and is so far on course to be realized in Phase III. “We’ve demonstrated that you revert back to normal platelet function within five to 15 minutes after infusion of the drug. For patients with internal trauma or blain bleed, the medication can stop the bleeding almost immediately,” Mow said. If bentracimab continues to yield the desired results through the rest of the Phase III study, PhaseBio will be on track to Biologics License Application in mid-2022. Bentracimab received Breakthrough Therapy Designation from the U.S. Food and Drug Administration in 2019. Given the unmet need for these bleeding emergencies, Mow speculated that bentracimab could be examined under expedited review, which means approval could come at the end of 2022 or in early 2023. In addition to hitting the primary reversal endpoint, bentracimab also met the co-primary endpoint of clinical hemostasis achieved in greater than 90% of patients. In the Phase III study, bentracimab appeared well tolerated with no drug-related serious adverse events. “Safety is so important in this patient population. The last thing you want is a reversal agent with complications,” Mow said. The Phase III data supported recent topline data from the Phase IIb clinical trial of bentracimab announced earlier this month. The Phase IIb study was conducted concurrently with the REVERSE-IT study, which was agreed upon by the FDA. The company was allowed to conduct the concurrent studies in order for the regulatory agency to see 300 exposures to the drug across its clinical work. Because bentracimab is used in an emergency event, the FDA knew it would be difficult to see larger numbers in a Phase III study, Mow said. The enrollment process for clinical trials assessing reversal assets can be long and challenging. For PhaseBio, that was further complicated by the ongoing COVID-19 pandemic. Mow joked that the Phase III study began in March 2020, “the day the world shut down.” Over the next several months the company was able to recruit the patients it needed to fill the study. However, Mow noted that the Phase III enrollment favored the surgical patients as opposed to the active bleeding patients due to COVID-19 conditions. In addition to the development of bentracimab, PhaseBio is also studying pemziviptadil (PB1046), a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of pulmonary arterial hypertension, a proliferative disorder of the pulmonary vasculature. Earlier this year, PhaseBio presented data from a Phase Ib/IIa pilot study highlighting three PAH patients who received pemziviptadil. The data showed a favorable safety profile, as well as clinically-meaningful, long-term improvement in a six-minute walk test. PhaseBio is also developing PB6440, an oral agent for the treatment of resistant hypertension. For now, though, the focus is on bentracimab. Following the potential filing of a BLA, Mow said the company will likely look for partners outside of the United States who can commercialize the medication in countries where Brilinta has been approved. “Brilinta is approved across the world and we want bentracimab to be available for use where it is,” Mow said.

Nov. 10, 2021 13:01 UTC Prespecified interim analysis of pivotal REVERSE-IT Phase 3 trial to be presented during late-breaking science session on November 15th at the American Heart Association’s Scientific Sessions 2021 Guest speakers include Deepak L. Bhatt, M.D., MPH; Charles Pollack, M.D.; and Philippe Gabriel Steg, M.D. Video webcast to be held on November 15, 2021, at 12:30 p.m. ET (9:30 a.m. PT) MALVERN, Pa. & SAN DIEGO--(BUSINESS WIRE)-- PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced that it will host an investor call on November 15, 2021, at 12:30 p.m. ET (9:30 a.m. PT) to discuss the results of a prespecified interim analysis of the pivotal Phase 3 REVERSE-IT trial that will be presented during a late-breaking science session at the American Heart Association Scientific Sessions 2021. REVERSE-IT is the company’s ongoing pivotal Phase 3 study evaluating bentracimab for the reversal of the antiplatelet effects of ticagrelor in patients who present with uncontrolled major bleeding or who require surgery or invasive procedure. Participants Include: Deepak L. Bhatt, M.D., MPH, Executive Director of Interventional Cardiovascular Programs, Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School Charles Pollack, M.D., MA, FACEP, Clinician-Scientist, Department of Emergency Medicine, University of Mississippi Medical Center in Jackson Ph. Gabriel Steg, M.D., FESC, FACC, Interventional Cardiologist and Chief of Cardiology of Hôpital Bichat in Paris, France and Professor of Cardiology at University of Paris Jonathan Mow, Chief Executive Officer, PhaseBio John Lee, M.D., Ph.D., Chief Medical Officer, PhaseBio The webcast will follow a presentation of the prespecified interim analysis data, which will be presented for the first time during a late-breaking science presentation at the American Heart Association Scientific Sessions 2021. A question and answer session with the PhaseBio management team and guest speakers will follow the presentation and roundtable discussion. Investor Call on November 15, 2021, at 12:30 p.m. ET (9:30 a.m. PT) The video conference call for investors and analysts will be held on November 15, 2021, at 12:30 p.m. ET (9:30 a.m. PT). Interested parties may RSVP to join the virtual event through the following registration link: . The webcast can also be accessed by phone by calling 833-942-2359 from the United States and Canada or 470-414-9401 internationally and using the conference ID/passcode 5616009. A replay of the presentation and discussion will be available for 60 days on the Events & Presentations page of the “Investors” section of the company’s website at . 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. Data from 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 FDA. In September 2019, PhaseBio completed a Phase 2a trial in which bentracimab was investigated in healthy, 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 November 2021, PhaseBio completed a Phase 2b trial in which bentracimab was investigated in healthy, older and elderly subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin. In all active treatment arms in both the Phase 2a and Phase 2b trials, 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 REVERSE-IT, a pivotal Phase 3 clinical trial of bentracimab, in March 2020 to support a potential Biologics License Application for bentracimab in both major bleeding and urgent surgery indications. About PhaseBio 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 vasoactive intestinal peptide (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. PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit , and follow us on Twitter @PhaseBio and LinkedIn. Forward-Looking Statements 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,” “potential,” “projects,” “target,” “will,” “would” 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 timing of availability or disclosure of data from those clinical trials and the timing of planned regulatory submissions, 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 filings, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 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.