HONG KONG – A Japanese phase III study of Chugai Pharmaceutical Co. Ltd.’s interleukin-6 inhibitor Actemra (tocilizumab) in patients hospitalized with severe COVID-19 pneumonia has read out, expanding what’s known about the drug’s use in the pandemic, which had been inconclusive until recently, though is now known to reduce mortality in the vulnerable population.
The FDA placed a partial clinical hold on atuzaginstat (COR-388) from Cortexyme Inc., of South San Francisco, stating that no new participants should be enrolled in the open-label extension portion of the phase II/III GAIN trial in mild to moderate Alzheimer’s disease.
Shares of Bluebird Bio Inc. (NASDAQ:BLUE) fell 37.8% to $28.44 on Feb. 16 as the company temporarily suspended two trials of its experimental gene therapy for sickle cell disease, Lentiglobin (BB-1111), while investigating one unexpected case of acute myeloid leukemia (AML) and another of myelodysplastic syndrome among participants in a phase I/II study of the candidate, called HGB-206. A second patient experienced MDS in 2018.
Amicus Therapeutics Inc.’s results from the phase III trial called Propel with AT-GAA (cipaglucosidase alfa and miglustat) for late-onset Pompe disease (LOPD) met with split opinions, though Wall Street took a decidedly dim view and left shares (NASDAQ:FOLD) to close at $12.57, down $6.16, or 33%.
BioWorld tracked a total of 295 phase I, II and III clinical news items in January, a rise of 39% compared with the number recorded during the pre-pandemic month of January 2020.
Recently published findings in JAMA Psychiatry related to the sharply increased risk of death from COVID-19 in people with schizophrenia put the spotlight on drug development in the space, which has been steadily heating up the past few years.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allovir, Amicus, Basilea, Denali, Dicerna, Jasper, Modra, Regeneron, Roche, Sanofi, Takeda.
An artificial intelligence (AI) algorithm developed by Geisinger researchers that uses echocardiogram videos predicted all-cause mortality at one year more accurately than three out of four expert cardiologists and other predictors commonly used in clinical practice, a study in Nature Biomedical Engineering demonstrated.
As COVID-19 variants have emerged, so have questions about the effectiveness of tests for infection. While the risk of mutations significantly limiting their ability to detect the novel coronavirus is thought to be relatively low, companies that make COVID-19 tests are moving quickly to enhance and revalidate their products.
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