Phase III
Lisa Stockman Mauriello was diagnosed with ALS in January and is seeking access to Biogen’s tofersen (BIIB067) through the Right to Try Act. Her case has reinvigorated the ALS community and its fight for expanded access to investigational therapies for this cruel, always fatal disease.
A new readout from a Phase IIb/III trial showed intravenous RLF-100 (aviptadil) met the primary endpoint of improving survival and recovery at 60 days post-treatment for respiratory failure in critically ill patients with COVID-19.
Humanigen, the biotech briefly run by “Pharma Bro” Martin Shkreli under the name KaloBios up until his arrest, is back in the game with an antibody that is keeping COVID-19 patients off of ventilators and improving survival.
Orphazyme announced its Phase II/III clinical trial of arimoclomal for inclusion body myositis (IBM) failed to hit both its primary and secondary endpoints.
There was a fair amount of clinical trial news last week. Here’s a look.
With oncology drugs clocking a disheartening 3.4% success rate, some good news in the field is always appreciated.
AstraZeneca released primary analysis that the vaccine demonstrated 76% efficacy against symptomatic COVID-19, 100% efficacy against severe or critical disease and hospitalizations and 85% efficacy against symptomatic COVID-19 in people 65 years and older.
Myovant Sciences and Pfizer announced positive results from the Phase III LIBERTY trial of relugolix combination therapy in women with uterine fibroids.
Targeted radioligand therapy 177Lu-PSMA-617 from Novartis significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) in patients with PSMA-positive metastatic castration-resistant prostate cancer.
Ionis Pharmaceuticals announced that its collaboration partner, Roche, was discontinuing dosing in the Phase III GENERATION HD1 trial of tominersen in manifest Huntington’s disease (HD).
PRESS RELEASES