Lilly, Biogen and Roche debut Alzheimer’s disease drug results
pharmafile | July 22, 2015 | News story | Research and Development | Alzheimer's, Alzheimer's disease, Biogen, Conference, Eli Lilly, Roche, lilly
Big pharma companies have posted mixed results in trials of several potential new treatments for Alzheimer’s disease.
But the results, presented at a conference in Washington DC, fell short of being the stand-out data to transform prospects for new drugs in this area.
Alzheimer’s disease R&D has a chequered history, with many high-profile failures over decades of unsuccessful trials in which 123 drugs have failed to post positive Phase III results – prompting accusations that companies are guilty of ‘funding fatigue’.
Lilly, Biogen and Roche all presented studies of their investigational treatments – solanezumab, aducanumab and gantenerumab, respectively. The three drugs block beta amyloid, a protein which causes toxic brain plaques considered a hallmark of the progressive brain disease.
In 2012 Lilly’s solanezumab failed in two key Phase III trials. Its hopes were revived when Lilly launched this latest study, which includes follow-up data from 1,322 mildly affected patients who continued to take solanezumab for the last two years (the ‘early start’ group), compared to those who had initially taken a placebo for 18 months but then switched over to the investigational drug (the ‘delayed start’ group).
Lilly’s trial found statistically significant differences in cognition and brain function between the early and the delayed start groups after two years, which were maintained after two and a half years.
Biogen presented interim results from a Phase IB study on aducanumab. In March it became the first experimental drug to significantly reduce beta amyloid in the brain and slow impairment in patients with mild disease in a Phase Ib study in 166 patients, and was recently fast-tracked towards a phase III clinical trial due to promising early results.
The latest aducanumab study tested the safety and effectiveness of the drug at different doses in people in the early stages of Alzheimer’s. The results suggest aducanumab could reduce amyloid plaques in the brain in a dose-dependent manner, and there were early indications that it could also slow decline in memory and thinking.
The results varied according to the dose. The 6mg form of aducanumab failed to reach statistical significance in two key measures, the Mini Mental State Examination (MMSE) and the Clinical Dementia Rating scale Sum of Boxes (CDR-SB). The 10mg performed better on these measures, but concerns remain as it was associated with adverse effects, including brain swelling and the leakage of fluid from the blood in the brain, which was greater at higher doses.
And a Phase III trial of Roche’s gantenerumab found it was beneficial for markers of Alzheimer’s disease in people with very early signs of the condition, and modestly reduced levels of amyloid in the brain and levels of another hallmark Alzheimer’s protein, called tau, in spinal fluid. These reductions were greatest for those patients on a higher dose of the drug.
Dr Eric Karran, director of research at Alzheimer’s Research UK, says: “It’s encouraging to see more treatments making it through to clinical trials in people with Alzheimer’s disease. Clinical trials represent the final, but biggest, hurdle for any new treatment to overcome and success at this stage could have huge implications for people living with Alzheimer’s and their families. We’re seeing global efforts to refine and improve clinical trial design in Alzheimer’s and the results announced today show that we should be more positive than ever about the direction in which we’re heading.”
Lilian Anekwe
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