New data from a global phase II trial of Kiniksa Pharmaceuticals Ltd.'s monoclonal antibody, mavrilimumab, in the rare chronic inflammatory disease giant cell arteritis showed a 62% lower risk of flare in patients receiving the candidate vs. those given a placebo.
HONG KONG – Cambridge, U.K.-based Astrazeneca plc has resumed phase I/II trials in Japan for AZD-1222, the experimental, adenovirus vector-based candidate coronavirus vaccine that it is co-developing with the University of Oxford.
Shares of Corvus Pharmaceuticals Inc. (NASDAQ:CRVS) climbed 19.4% to $4.86 Oct. 5 after the company said updated data from an ongoing phase I study of CPI-006 as an immunotherapy for COVID-19 continued to support its development in that area.
LONDON – Clinical care guidelines recommending the use of the HIV/AIDS combination lopinavir-ritonavir for the treatment of patients hospitalized with COVID-19 must now be updated, say the authors of a paper reporting the full results of a randomized U.K. study showing the antiviral is not effective in this context, published in The Lancet on Oct. 5.
Synthetic Biologics Inc. said a phase IIb trial of one of its two lead candidates, SYN-010, in people with constipation-predominant irritable bowel syndrome (IBS-C) will be discontinued after an interim futility analysis suggested it was unlikely to meet the study's primary endpoint.
Pharmacyte Biotech Inc. is now in a series of 30-day cycles with the FDA as a planned phase IIb study of its lead candidate has been placed on hold. On Sept. 2, Pharmacyte submitted its IND for a phase IIb trial of its product, known as Cypcap, in locally advanced, inoperable pancreatic cancer and, on Oct. 2, the company said the FDA placed the application on hold.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aiviva, Algernon, Astrazeneca, Cytokinetics, Epygenix, Kyowa, Mei, Otonomy, RVL, Synthetic Biologics, Xencor.
With phase III vaccine trials nearly enrolled and data expected soon, a half-year of expedited development efforts, plus massive government funding may soon provide the ammunition needed to effectively stop the SARS-CoV-2 scourge of 2020.
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