Phase III
It was a busy week for clinical trial announcements and news. Here’s a look.
Amicus Therapeutics announced topline results from its Phase III PROPEL pivotal trial of AT-GAA (cipaglucosidase alfa and miglustat) for late-onset Pompe disease (LOPD). Although the results showed some positive data, it failed to hit the primary endpoint.
In the waning weeks of the fourth quarter of the 2020 fiscal year, AstraZeneca terminated several clinical programs, including some oncology and heart-related studies, as well as one COVID-19 related trial.
Belgium-based Galapagos NV and Foster City, California-based Gilead Sciences halted the ISABELA Phase III clinical trial of ziritaxestat in idiopathic pulmonary fibrosis.
ZYESAMI is intended to block the replication of SARS-CoV-2 in the ATII cell, as well as cytokine synthesis, thereby relieving respiratory distress. It is the only treatment in development that targets these ATII cells, and if approved, would be the first drug on the market for COVID-19 patients critically ill with respiratory failure.
A final analysis of the Phase III TITAN study shows that Janssen’s ERLEADA®, when added to androgen deprivation therapy, significantly improved overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) compared with placebo.
Bristol Myers Squibb and Exelixis announced new analysis from the Phase III CheckMate -9ER clinical trial.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 9, 2021.
The Swiss health authority Swissmedic rejected AstraZeneca’s rolling authorization application for its COVID-19 vaccine a few days ago, saying more data is needed “to obtain more information about safety, efficacy, and quality.”
Over the course of 2020, Sanofi saw significant growth in its specialty care sales primarily driven by its blue-chip asset, Dupixent, as well as an increase in vaccine sales that were driven by demand for differentiated influenza vaccines, the company announced in its year-end financial report.
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