LONDON – The U.K. Recovery trial has added a fourth drug to the list of therapies it has shown are effective in treating hospitalized COVID-19 patients, demonstrating the JAK inhibitor Olumiant (baricitinib) reduces the risk of death by 13% in seriously ill patients. That effect is in addition to treatment with dexamethasone, which became standard of care after the Recovery trial showed it reduced mortality by one-third in patients on ventilators.
Another shoe dropped on Oncopeptides AB when the U.S. FDA issued an alert July 28 citing trial data showing an increased risk of death with the company’s only marketed drug, Pepaxto, used in combination with dexamethasone to treat multiple myeloma. The agency said it’s continuing to evaluate the Ocean trial results and may hold a public meeting to discuss the safety findings and explore the continued marketing of Pepaxto (melphalan flufenamide), which was granted accelerated approval in February as a fifth-line treatment for relapsed or refractory multiple myeloma.
LONDON – Adding to the immediate and obvious toll of serious illness and death, COVID-19 seems likely to be fueling development of resistance to antibiotic drugs, according to the findings of the most comprehensive analysis to date.
LONDON – A year on from delivering positive phase IIb data, Oculis SA has raised $57 million in an oversubscribed series C, to take OCS-01, a topical nanoparticle formulation of dexamethasone, through two phase III trials.
LONDON – Oxular Ltd. has raised $37 million in a series B, enabling the company to take OXU-001, its long-acting treatment for diabetic macular edema (DME) into phase II development later this year.
Hopes that a second clinical win for Otonomy Inc.'s phase III Meniere's disease candidate, Otividex, might set the stage for a third-quarter registration of the drug in the U.S. have been dashed, sending company shares (NASDAQ:OTIC) down 44.3% to $3 on Feb. 22. For the intent-to-treat (ITT) population, the trial missed its primary endpoint, the count of definitive vertigo days in month three for the sustained-exposure dexamethasone therapy vs. placebo. The trial also failed to achieve statistical significance for a per-protocol analysis. It was déjà vu for the company, which suffered a harsh reaction to an earlier setback for the program from which its stock has yet to recover, years later.
LONDON – After a number of equivocal small studies, the U.K. Recovery trial has applied its heft to turn in statistically significant evidence that the rheumatoid arthritis treatment Roactemra (tocilizumab) reduces mortality in hospitalized COVID-19 patients.
Data from a newly published case series underscores the effectiveness of Cytosorbents Corp.’s blood purification technology in treating critically ill COVID-19 patients.
LONDON – New evidence from seven randomized controlled trials and a simultaneously conducted meta-analysis has again demonstrated that corticosteroids show significant benefit in patients who are critically ill with COVID-19, reducing length of hospital stay and cutting 28-day mortality.
