Santhera's idebenone hits top-line in Phase III DMD trial
This article was originally published in Scrip
Executive Summary
Santhera Pharmaceticals' Phase III DELIOS study of idebenone in Duchenne muscular dystrophy (DMD) has reached its primary endpoint of delaying the loss of respiratory function compared with placebo, the company says. It is planning to talk to US and EU regulators about the best way forward for the product on the back of the data.
You may also be interested in...
Santhera Setback Could Have Wide-Reaching Effects For DMD Drugs
The DMD community faces another setback as FDA pushes back timelines for Santhera and its respiratory drug, pushing the market to question what will come for other DMD treatments in development.
The Shifting Sands Of Biopharma R&D
A year is a long time in biopharma. Pharmaprojects’ annual pipeline review finds changes in the therapeutic spread of drug candidates and a reordering of the top R&D companies, as Chinese firms made their presence felt all the more over the past 12 months.
Nine Pivotal Studies To Look Out For In 2024
While not expected to be quite so busy as previous years, 2024 will still see many pivotal clinical trial readouts that should create a splash. Here are nine (plus a few extras) that have caught attention for one reason or another, e.g., for being the first readout for a novel drug class, having the potential to take a product in a new lucrative direction, for maybe being able to succeed where a rival has already failed or even for having been a long time coming.