September 7, 2017
By Alex Keown, BioSpace.com Breaking News Staff
BASEL, Switzerland – David Hung has never given up hopes of developing a treatment for Alzheimer’s disease.
As the new chief executive officer of Axovant Sciences , he’s getting another shot at that goal. Later this month, the company is expecting a readout from its MINDSET trial, which is testing RVT-101 (inteperdine), as a treatment for Alzheimer’s. Axovant acquired RVT-101, a 5-HT6 receptor antagonist, from GlaxoSmithKline after that company gave up on it following multiple trial failures. Axovant founder Vivek Ramaswamy believes there is potential for RVT-101, as does Hung. The MINDSET trial is looking at 1,315 patients on a stable background therapy of donepezil (Aricept) who will receive either intepirdine or a placebo. A 5-HT6 receptor antagonist is believed to work as a treatment for Alzheimer’s by increasing the release of acetylcholine in the brain. It would not cure Alzheimer’s. At best, it’s seen as a drug that can delay a worsening of symptoms.
Hung might be best known for selling oncology drugmaker Medivation , the company he founded and helmed, for $14 billion to Pfizer last year. Before Medivation was known for its prostate cancer drug Xtandi, the company had hoped to develop a treatment for Alzheimer’s disease. However, in 2010, the company’s lead drug failed – and failed big. In a look back at Hung’s career, and his deep interest in Alzheimer’s research, Stat News noted that the drug, Dimebon, failed all five of the trial’s key metrics. In two metrics, the drug was outperformed by placebo, Stat said. With that failure, as well as more than $1 billion in market loss, Medivation shifted its focus to oncology and the rest, for that company, is history.
However, it seems that Hung never gave up on his dream of finding a treatment for Alzheimer’s disease – something that has eluded numerous drugmakers, including Eli Lilly and Denmark-based H. Lundbeck A/S , which scrapped its own 5-HT6 receptor antagonist for Alzheimer’s earlier this year.
Lundbeck’s failure, coupled with the previous interperdine failures, makes analysts wary about the outcome of RVT-101. Baird analyst Brian Skorney told Stat he gives Axovant’s drug 60 percent odds of success. Nearly all experimental Alzheimer’s drugs, about 99 percent, fail to achieve endpoints. As BioSpace noted earlier this year, well more than 125 Alzheimer’s drugs have failed in Phase III trials after promising results in early-stage trials. There has not been a newly approved Alzheimer’s treatment for at least 15 years, according to Stat.
When Hung joined Axovant earlier this year, he told reporters that he had gone over the data for RVT-101. Although he was careful to note that drugmakers take risks in attempting to develop treatments for Alzheimer’s, it was a rrisk worth taking.
Alzheimer’s disease, a type of dementia, affects 15 million people worldwide, a number that is expected to grow to 75 million by 2030 due, in part, to the lack of effective treatments. In total, there are about 50 million people suffering from some form of dementia worldwide. There are currently no drugs that target the cause of Alzheimer’s the most common form of dementia.
In addition to RVT-101, Axovant is also developing nelotanserin, for the visual hallucinations caused by Alzheimer’s disease and Lewy body dementia.
