Hightide Therapeutics Inc. presented top-line results of its lead program, HTD-1801, from a multicenter phase II trial in primary sclerosing cholangitis (PSC), which showed the drug candidate reduced alkaline phosphatase levels compared to placebo.
Medigen Vaccine Biologics Corp. released results from a phase III trial of its enterovirus 71 (EV71) vaccine that showed efficacy of 100% against a virus that causes hand, foot and mouth disease and continues to emerge on a regular basis across Asia.
A study presented this week at the European Society of Human Reproduction and Embryology (ESHRE) annual conference demonstrated that the noninvasive artificial intelligence (AI) technology developed by Aivf Ltd. can instantly differentiate between genetically normal and abnormal human embryos, increasing the likelihood of successful pregnancy for couples using in vitro fertilization.
Medtronic plc kicked off an app-based research study to improve understanding of atrial fibrillation (AF) disease burden and its impact on patient outcomes, quality of life and health care utilization. The first patients in the DEFINE AFib study were enrolled at Duke University Medical Center and the Florida Electrophysiology Associates in Atlantis, Fla. “When it comes to managing atrial fibrillation, there is not a ‘one-size-fits-all’ approach, and the hope is that DEFINE AFib may give us the tools to help personalize AF management based on a patient’s individual health profile and physiology,” said Jonathan Paul Piccini, director of cardiac electrophysiology and associate professor of medicine at Duke University School of Medicine and chair of the DEFINE AFib Steering Committee. “DEFINE AF will harness the power of digital health to make fundamental discoveries about how we can manage atrial fibrillation better in each and every one of our patients.”
Shares of Sensei Biotherapeutics Inc. (NASADQ:SNSE) fell 16% to $9.10 on June 29 after an announcement by President and CEO John Celebi that the antigen display technology used in its prior lead candidate, SNS-301, "is suboptimal for use in an active cancer vaccine." A phase I/II trial evaluating it will be discontinued, he said. Now, work on a next-generation vaccine, SNS-401-NG, and the monoclonal antibody SNS-VISTA will take precedence in a portfolio reprioritization at the company, with IND-enabling studies for the anti-VISTA program planned to start by the end of 2021 and for the next-gen vaccine in second half of 2022.
Diamedica Therapeutics Inc.’s chief medical officer, Harry Alcorn, said that “due to the complexity [of diabetic kidney disease (DKD)], there's not a clear answer” as to why such patients did less well in the company’s Redux phase II trial with DM-199 (recombinant human tissue kallikrein 1 [KLK1]). “But I wouldn't say that there wasn't a response in the DKD group,” he said, citing upside in 30% of subjects.
While stakeholders have concerns about the costs of registries for medical devices, they are still generally seen as less expensive and simpler to administer than randomized, controlled clinical trials (RCTs). A new journal article compares the quality of the data from a registry and the data generated by a clinical trial, and despite an interest in ascertaining whether registry data provided similar data quality, the authors concluded that registry data is still more useful as a means of supporting, rather than supplanting, the RCT.
Top-line data from a phase II trial of Italfarmaco SpA's givinostat in men with Becker muscular dystrophy found it failed to affect a significant change in total muscle fibrosis vs. placebo, the study's primary endpoint. But whether the outcome reflected a shortcoming of the drug or a function of the rare condition's clinical profile remained uncertain, with the company placing its bets on the latter.
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