by JD Journal:
A Swiss drug manufacturer, Roche Holding AG, feels that it has taken the lead in the race to develop a drug that could alter the course of Alzheimer’s disease since many other companies suffered setbacks. A clinical trial operated by the company has been doubled in size so its experimental drug known as gantenerumab can be tested in patients who have not been diagnosed with dementia yet.
“The playing field has changed dramatically and gantenerumab is now the most advanced monoclonal antibody in early Alzheimer’s and the next big news to read out in this space,” Luca Santarelli, Roche’s head of neuroscience, said in an interview.
“We targeted this space four years ago and our trial started at the end of 2010, so we are way ahead,” Santarelli said.
The data from the study is not expected to be released until sometime in 2015. The trial, which has increased from 360 patients to 770 patients moves it into a final-stage Phase III. Roche hopes that the trial will show an effect because tests have shown that the drug being tested can help reduce amyloid plaques in the brain. These plaques are linked to the disease.
Roche might be able to file for marketing approval with just one trial if the company’s results are incredibly strong. There are three other drugs being tested by Roche right now and they include crenezumab. This drug was picked by the U.S. government for a trial in Colombians who suffer from genetic mutations that cause Alzheimer’s in their 40s.