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AstraZeneca says that the SOCRATES trial that assessed the efficacy of Brilinta/Brilique (ticagrelor) compared with aspirin in patients with acute ischemic stroke or transient ischemic attack missed its primary endpoint of time to first occurrence of any event from the composite of stroke, heart attack, and death. “Fewer events were observed on Brilinta/Brilique versus the comparator in the overall trial population, but the trend did not reach statistical significance,” the company says. Brilinta/Brilique is described as a direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic cardiovascular events.
Sanofi and Regeneron say that the Phase 3 ODYSSEY ESCAPE trial evaluating Praluent (alirocumab) injection in patients with heterozygous familial hypercholesterolemia, whose cholesterol levels required chronic, weekly or biweekly apheresis therapy, met its primary endpoint. The companies say the trial demonstrated that patients who added Praluent to their existing treatment regimen significantly reduced the frequency of their apheresis therapy by 75% compared to placebo. Some 63% of Praluent patients no longer required apheresis, compared to zero percent of placebo patients.
Merck has agreed to pay Harvard University $20 million under an exclusive license and research collaboration agreement with Merck to further develop small-molecule therapeutics for leukemia and other cancers. The novel compounds, developed in the laboratory of Harvard scientist Matthew Shair, offer an innovative approach to cancer treatment by targeting enzymes that regulate transcription, a university release says. Supported by Harvard’s Blavatnik Biomedical Accelerator, Shair’s laboratory “developed highly selective and potent small molecules, with favorable pharmaceutical properties, that are now poised for advancement toward clinical trials,” the university says. “Merck will take over development of the candidate therapeutics and will engage in a research collaboration with the Shair laboratory to further investigate the biology of transcriptional regulator enzymes.”
Novo Nordisk says it broke ground on a new diabetes medicine production facility in Clayton, N.C., which will produce active pharmaceutical ingredients for several of the company’s current and future GLP-1 and insulin medicines. The company says the facility will be fully operational in 2020, will measure 833,000 square feet, and is expected to create about 700 jobs.
Biotechnology company Forge Therapeutics and Active Motif, an expert in epigenetic research tools, have entered into a research collaboration to advance epigenetic research related to the family of iron-containing lysine demethylases known as Jumonji KDMs. According to the companies, they intend to validate epigenetic targets for oncology indications and demonstrate the therapeutic abilities of Jumonji KDMs.
Kobe, Japan-based Sysmex Corp. and Singapore-based Clearbridge BioMedics have partnered to develop a new liquid biopsy system. The collaboration will use Clearbridge’s microfluidics and cell separation technologies and Sysmex’s expertise in hematology diagnostics and in developing liquid biopsy assays to enrich rare cells.