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.

Los Angeles, USA, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Pulmonary Arterial Hypertension Pipeline Insight Research Report Around 55+ key companies are developing therapies for Pulmonary Arterial Hypertension, among which the drug of Liquidia Technologies is in the advanced stage (Pre Registration) DelveInsight’s “Pulmonary Arterial Hypertension (PAH) Pipeline Insight” report provides comprehensive insights about 55+ companies and 55+ pipeline drugs in the Pulmonary Arterial Hypertension pipeline landscapes. It comprises Pulmonary Arterial Hypertension pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Pulmonary Arterial Hypertension therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Pulmonary Arterial Hypertension pipeline products. Some of the key takeaways from the Pulmonary Arterial Hypertension Pipeline Report Get an overview of pipeline landscape @ Pulmonary Arterial Hypertension Clinical Trials Analysis Pulmonary Arterial Hypertension (PAH) is a rare, progressive disorder characterized by high blood pressure in the arteries of the lungs for no apparent reason. Pulmonary Arterial Hypertension Emerging Drugs Sotatercept is a first-in-class therapeutic fusion protein composed of the extracellular domain of human activin receptor type IIA, fused to the Fc domain of human immunoglobulin G1 (IgG1). The United States Food and Drug Administration (FDA) has granted Orphan Drug designation and Breakthrough Therapy designation to sotatercept for the treatment of PAH; the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to sotatercept for the treatment of PAH. Sotatercept is in Phase III clinical trials for the treatment of PAH. LIQ861 is an investigational, inhaled dry powder formulation of treprostinil designed using the Company’s novel PRINT technology and engineered to enhance deep-lung delivery of treprostinil in PAH patients using a convenient, palm-sized dry powder inhaler. Liquidia resubmits New Drug Application for LIQ861 under the 505(b)(2) regulatory pathway for the treatment of pulmonary arterial hypertension (PAH). Gossamer Bio is developing Seralutinib (GB002) for the treatment of Pulmonary Arterial Hypertension. It is currently in the Phase II stage of development (NCT04456998). It acts as an inhibitor of Platelet-derived growth factor receptors,  CSF1R, c-KIT. Bial is developing Zamicastat for the treatment of Pulmonary Arterial Hypertension. It is currently in the Phase II stage of development (NCT04316143).  It acts as an inhibitor of Dopamine beta-hydroxylase. For further information, refer to the detailed report @ Pulmonary Arterial Hypertension Pipeline Therapeutics Scope of Pulmonary Arterial Hypertension Pipeline Drug Insight ·       Pulmonary Arterial Hypertension Therapies Late-stage (Phase III)  ·       Pulmonary Arterial Hypertension Therapies Mid-stage (Phase II)·       Pulmonary Arterial Hypertension Therapies Early-stage (Phase I) ·       Pulmonary Arterial Hypertension Preclinical stage and Discovery candidates     ·       Discontinued and Inactive candidates ·      Epoprostenol receptor agonists·      Activin inhibitors·      Platelet-derived growth factor receptor antagonists·      Dopamine beta-hydroxylase inhibitors·      Vasoactive intestinal peptide type II receptor agonists·      Angiogenesis inhibitors; Bcr-abl tyrosine kinase inhibitors ·      Cyclin-dependent kinase 4 inhibitors; Cyclin-dependent kinase 6 inhibitors·      Galectin 3 inhibitors ·     Peptides·     Monoclonal antibodies·    Small molecules ·    Proteins·    Gene therapy ·     Parenteral ·      Oral·      Intravenous·      Subcutaneous ·       Monotherapy·       Combination·       Mono/Combination Key Questions regarding Current Pulmonary Arterial Hypertension Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customized pipeline report @ Pulmonary Arterial Hypertension Drugs Pipeline Report Other Reports About DelveInsightDelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.