Clinical research
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.
With billions invested in R&D over the past year to find vaccines and therapies for the novel coronavirus, a few select life sciences companies and academic institutions are working on the hypothesis that intranasal vaccines and therapies could be key to stopping COVID-19 in its tracks, and provide greater protection against transmission of COVID-19.
The company’s head of drug development, Samit Hirawat, told analysts in a conference call last week that the decision was about working with the best drugs, particularly in a crowded field like BCMA.
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.
Switzerland-based AC Immune SA announced positive interim results from its ongoing Phase Ib/IIa clinical trial of ACI-35.030 for Alzheimer’s disease.
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.
Tryp and Dr. Miller have begun designing a Phase 2a open-label, exploratory clinical study utilizing TRP-8802 in patients suffering from rare and orphan over-eating disorders.
Veru announced positive results from its Phase II trial of its VERU-111 compared to placebo in hospitalized patients at high risk for Acute Respiratory Distress Syndrome (ARDS) from COVID-19.
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