In the summer of 2016, when Victoria, British Columbia-based Aurinia Pharmaceuticals Inc. offered phase IIb results with its calcineurin inhibitor voclosporin in lupus nephritis (LN), Wall Street ignored the otherwise-positive results and zeroed in on the trial’s death rate: 13 casualties across three arms of the 265-subject Aura-LV study.
A pivotal trial of Omeros Corp.'s narsoplimab, an investigational therapy for an occasional but serious complication of hematopoietic stem cell transplant (HSCT), found that just one dose was enough to deliver a beneficial effect in more than half the study's high-risk participants, meeting the study's primary endpoint.
New top-line results from a phase III study of Ardelyx Inc.'s tenapanor – recently approved in irritable bowel syndrome – confirmed the drug can also help dialysis-dependent chronic kidney disease patients with hyperphosphatemia achieve reduced serum phosphorus levels vs. placebo.
Protagonist Therapeutics Inc. stock (NASDAQ:PTGX) nosedived 47% on Tuesday after the company released preliminary results from its phase II open-label study of PTG-300, an injectable hepcidin mimetic to treat patients with transfusion-dependent beta-thalassemia.
The recent controversy over the use of paclitaxel in the peripheral vasculature has clouded the larger debate over whether bypass is superior to endovascular therapies for the lower limbs. However, a new study suggests that nitinol stents provide a feasible alternative to bypass even for lesions of the femoropopliteal artery that are 30 cm in length.
Proteus Digital Health Inc.’s digital medicine program, Digimeds, achieved 95% adherence in patients with hepatitis C virus (HCV) who typically would not be offered direct acting antivirals because of their high risk for nonadherence as a result of mental illness, transportation issues or previous evidence of nonadherence.
Proteus Digital Health Inc.’s digital medicine program, Digimeds, achieved 95% adherence in patients with hepatitis C virus (HCV) who typically would not be offered direct-acting antivirals because of their high risk for nonadherence as a result of mental illness, transportation issues or previous evidence of nonadherence.
Positive phase III data from the Advocate trial by Chemocentryx Inc. and Vifor Fresenius Medical Care Renal Pharma caused Chemocentryx’s stock (NASDAQ:CCXI) to dramatically rise 281% on Tuesday, clearing the way to an NDA filing for the star small-molecule attraction, avacopan, an oral, selective complement 5a receptor inhibitor.
SINGAPORE – While a lot of focus is placed on phase III trials and the subsequent approvals, panelists during the ESMO Asia Congress pointed to the importance of designing the right kind of phase I trials, from reaching global populations to using appropriate endpoints.