Solanezumab phase 3 results – Alzheimer’s Research UK comment

Two phase 3 clinical trials of a potential Alzheimer’s drug have reported their first results.

Posted on 24th August 2012

It has been reported today that two phase III clinical trials of a potential Alzheimer’s drug have not met their primary goals. The drug Solanezumab was tested by Eli Lilly & Co in 2,050 people with mild to moderate stage Alzheimer’s disease.

Although neither of the two trials, known as EXPEDITION 1 and 2, met their main goals of preserving mental performance and functional abilities, a secondary analysis of data from both trials showed some slowing of cognitive decline in patients with mild Alzheimer’s disease.

Reported side-effects included lethargy, rash, malaise and angina. Lilly now plans to discuss the findings with regulators before deciding the next steps for the drug.

Dr Eric Karran, Director of Research at Alzheimer’s Research UK, said:

“While it’s very disappointing that this drug did not meet its primary goals in these phase 3 trials, there did appear to be some effect on cognitive decline in people with mild Alzheimer’s. We need to wait for the full trial data to be published before it is possible to assess the significance of these findings for patients. Secondary analysis showed some benefits for some patients in the two trials, suggesting that this drug may still be worthy of further investigation.

“Solanezumab aims to target amyloid, a hallmark protein involved in Alzheimer’s disease, which we now know starts to build in the brain years before symptoms appear. Many scientists believe that drugs targeting amyloid will need to be given early. The fact that the best results were seen in people in the earlier stages of the disease appears to add weight to this theory.

“The ability to detect the disease much earlier will be vital to identify the right people for future clinical trials at the right time, and research is making good progress in this area. Research is now planned to start testing these kinds of drugs in people much earlier, and we hope that these trials will show greater benefits for people.

“Already half a million people are living with Alzheimer’s in the UK and that number is expected to soar. We urgently need a treatment that can halt the disease in its tracks, and the findings from these trials will help shape new discoveries in the future.”

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