“There is a big need for a drug in outpatients. If you could treat them and keep them out of hospitals, that would be important and play a big role in getting us through this pandemic,” Romark Laboratories LC’s CEO, Marc Ayers, told BioWorld.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve Life Sciences, Agenus, Aligos, Ardelyx, Ascletis, Astrazeneca, Auris, Endo, Galectin, Gannex, Innocoll, Kyowa Kirin, Moderna, Nervgen, Orphomed, Proqr, Rocket, Romark, Synthetic Biologics and Veracyte.
HONG KONG – Covig-19, an anti-SARS-CoV-2 hyperimmune immunoglobulin therapy that Takeda Pharmaceutical Co. Ltd. developed alongside the Covig-19 Plasma Alliance, has failed to meet its endpoints in a global phase III trial.
Challenges to ongoing efforts to provide effective aid for hospitalized patients with COVID-19 continued April 8, with two new trial failures reported. A phase III trial testing the Olumiant (baricitinib) vs. placebo, both on top of standard of care, missed its primary endpoint of progression to non-invasive ventilation, invasive mechanical ventilation or death, said drugmakers Eli Lilly and Co. and Incyte Corp. A phase II trial testing Beigene Ltd.'s Brukinsa (zanubrutinib) vs. placebo in patients hospitalized with respiratory symptoms of COVID-19 also fell short, missing its co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen.
HONG KONG – In a surprisingly candid statement, the director of China’s Centers for Disease Control conceded that the efficacy of Chinese coronavirus vaccines is "not high" and may require improvements.
LONDON – The U.K. is moving on to the next phase of testing mixed dosing schedules for COVID-19 vaccines, launching a study in which it will assess the effect of using Moderna Inc. or Novavax Inc.’s products as the second dose in a heterologous prime boost trial.
LONDON – A large scale prospective study has shown that increased blood plasma viscosity is correlated with disease severity and the likelihood of progression to organ failure, in patients who are hospitalized with COVID-19 infections. Researchers at Addenbrooke’s Hospital in Cambridge, U.K. suggest this could be an easy but sensitive way to quickly triage patients admitted to hospital with symptoms of COVID-19.
Among a spate of COVID-19-related therapy developments to start the week, Kiniksa Pharmaceuticals Inc. produced positive phase II data of its monoclonal antibody, mavrilimumab, in treating non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation.