Novo Nordisk is set to put its diabetes treatment liraglutide into late-stage Alzheimer’s trials if the drug can prove its potential early studies that are currently be carried out by scientists in the UK.
Speaking to PMLiVE at the European Association for the Study of Diabetes’ (EASD) 2013 meeting in Barcelona last week, Novo’s chief science officer Mads Krogsgaard Thomsen confirmed the drug, approved to treat type 2 diabetes under the name Victoza, was under investigation by Imperial College London in what Thomsen referred to as a “proof-of-concept” study.
If successful, the study would then be enough impetus for Novo to step up its research and move liraglutide in phase III clinical trials for Alzheimer’s.
“The study that they’re doing at Imperial would suffice for Novo to make the thumbs up decision,” Thomsen told PMLiVE.
“Ideally, we would then take liraglutide into phase III confirmatory testing in Alzheimer’s. But that would have to be pending discussions with regulators.”
A decision won’t be made any time soon, with the Imperial study having only just started recruiting and sufficient data not expected for up to three years.
The study is backed by several sponsors, including the charity the Alzheimer’s Society, as well as Novo and Imperial itself.
It follows promising work into liraglutide’s effect on Alzheimer’s by such researchers as Professor Christian Hölscher and his team at Lancaster University whose research suggests that, based on trials involving mice, the drug can reverse memory loss and the build-up of amyloid plaques on the brain related to the dementia.
As mentioned by Thomsen, drug development has been a “graveyard” in recent years for the pharma industry, with several major trial failures from the likes of Lilly, Pfizer/Johnson & Johnson and Bristol-Myers Squibb.
Investigating a drug already in use has benefits, however, as liraglutide has already passed through large parts of the drug development process, making research much cheaper and faster.
This is a view shared by the US National Institutes of Health (NIH), which announced last month that it will provide funding to a project by a team at the Icahn School of Medicine at Mount Sinai to use computational methods to determine if existing drugs for other conditions can be used to treat Alzheimer’s.
Other diabetes drugs that have shown potential benefit in Alzhiemer’s include Takeda’s Actos (pioglitazone hydrochloride), which is in phase III trials investigating its use in people at risk of developing the symptoms of Alzheimer’s disease.
Liraglutide to treat obesity
In addition to its potential in Alzheimer’s, Thomsen confirmed that Novo expects to file liraglutide as a treatment for obesity in the US and EU by the end of 2013.
The GLP-1 agonist has demonstrated its promise as an adjunct therapy for weight loss in clinical trials, and Novo is looking to expand its reach beyond diabetes.
Thomsen was also confident the drug would be a success in a market that has been tough for the new treatment options Qsymia from Vivus and Belviq from Arena/Eisai.
“Our product has a very different profile compared to Qsymia or Belviq – the two agents approved in the US,” said Thomsen.
“The dose of Qsymia that gives good weight control is also the dose that gives side effects. This is not the case with liraglutide. So I think the overall benefit to risk profile is pretty different.”
Thomsen explained the difference went beyond each drug’s profile.
“Our approach in marketing the agent is also different,” he said. “We’re focusing on a big niche of patients who have class two or three obesity; those who have BMI above 35 or 40.
“We are also going for the complications of obesity, such as pre-diabetes or sleep apnoea. When you look at these conditions, [treatments] can pan out for the patients and for the health economy, then I think we can carve out a niche of patients who fulfil this criteria.”