LONDON – The U.K. will become the first country to stage a human challenge trial in which volunteers are deliberately infected with SARS-CoV-2, as a fast route to assessing the effectiveness of COVID-19 vaccines, and to build understanding of what an effective immune response looks like. The contract research organization Open Orphan plc said it is in advanced negotiations with the U.K. government and other partners for the studies, which are expected to be formally announced next week.
DUBLIN – Afimmune Ltd. is starting a phase IIb trial of a bioactive lipid, epeleuton, in patients with high triglycerides and type 2 diabetes, in an effort to confirm prospective observations already seen in a phase IIa study.
Two studies seek to answer the most pressing question for physicians examining a patient with COVID-19: What's this person's risk of death? Mount Sinai researchers presented their clinical prediction model in The Lancet Digital Health and a team from Johns Hopkins published their risk calculator in the Annals of Internal Medicine.
DUBLIN – Shares in AC Immune SA were off more than 40% Sept. 23 on news that its tau-directed antibody, semorinemab, which is partnered with Genentech, failed to demonstrate efficacy in a phase II trial in Alzheimer’s disease.
HONG KONG – New data from Beigene Ltd. recently presented at the ESMO Virtual Congress 2020 showed its PARP inhibitor pamiparib helped shrink tumors in almost 65% of people with platinum-sensitive ovarian cancer treated with the candidate during a pivotal trial.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Actinium, Afimmune, Bridge, Clearside, Cytokinetics, Dr. Reddy's, Durect, Enterome, Genentech, J&J, Macrogenics, Morphic, Neximmune, Nicox, Oncimmune, Selecta, Sobi, Takeda, Verona, Vtv.
Shares of Vaccinex Inc. fell to an all-time low on Sept. 22 after top-line results of the phase II trial, Signal, found its SEMA4D inhibitor, pepinemab, failed to improve measures of cognition in people with early manifest Huntington's disease following 18 months of treatment.
Positive top-line data from Blueprint Medicines Corp.’s phase I and II trials of Ayvakit (avapritinib) for treating advanced systemic mastocytosis (SM) are pushing the company to submit an sNDA before 2020 ends.
While the ultimate goal is increased diversity in clinical trials so as to improve health equity, a great start is making diversity a priority and a part of the research plan, Luther Clark, deputy chief patient officer at Merck & Co. Inc., said during an FDA Office of Minority Health and Health Equity webinar Sept. 22.
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