PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia. The company had reported in December 2020 that the allogeneic mesenchymal cell therapy failed to meet the primary endpoint of a reduction in hospitalizations in its DREAM-HF phase III trial.
There is now more clarity on the Omicron variant of SARS-CoV-2, as serum antibodies produced by three doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine have been shown to neutralize it. The data arrived a day after Glaxosmithkline plc and Vir Biotechnology Inc. said the monoclonal antibody sotrovimab retains activity against key mutations of the Omicron variant, including those found in sotrovimab’s binding site.
PERTH, Australia – Neuren Pharmaceuticals Ltd.’s stock nearly doubled on positive top-line phase III results for trofinetide in Rett syndrome, meeting all primary and secondary endpoints in the pivotal phase III trial run by partner Acadia Pharmaceuticals Inc.
Despite hitting the primary endpoint in its phase III study of pegzilarginase in treating arginase 1 deficiency, Aeglea Biotherapeutics Inc. had a tough go of it Dec. 6 as the price of its stock (NASDAQ:AGLE) plunged 36.5% to close at $3.81 per share. The study hit its primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks of treatment with pegzilarginase (p<0.0001). The study results were positive enough to prompt Aeglea to say it planned to submit a BLA to the FDA in the first half of 2022.
Shares in Isofol Medical AB dropped by 27% on Dec. 6 as the company informed investors that its ongoing phase III trial of arfolitixorin in metastatic colorectal cancer would not reach the predefined number of events needed to demonstrate a statistically significant effect on progression-free survival (PFS) based on the study’s present statistical plan.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 180 Life Sciences, Acasti, Amgen, Arbutus, Arca, Bonus, Hepagene, Humanigen, India Globalization, Immutep, Karyopharm, Redhill, Revelation, Spago, VBI, Ysopia.
LONDON – Each of six different COVID-19 vaccines given as booster doses were safe and increased immunity when administered after two doses of either Pfizer Inc.’s or Astrazeneca plc’s vaccine, according to the latest data from the U.K. Cov-Boost trial.