Experimental Alzheimer’s drug shows some benefit
Innovating care in a tough-to-treat indicationIn its presentation on Wednesday, the company will unveil data showing whether or not solanezumab can halt Alzheimer’s disease progression in patients suffering from a mild form of the disease. Eric Siemers, medical director for Lilly’s Alzheimer’s team, said if solanezumab can slow disease progression by roughly a third, as it did in the first two Phase III trials, that would be very meaningful to patients.
Solanezumab is seen as the great hope in modern dementia research, and targets deformed proteins which build up in the brain and cause cell death during Alzheimer’s.
Currently, doctors can only prescribe medication that alleviates some of the symptoms for sufferers, but nothing on the market specifically targets the root of the disease itself.
The study of about 2,100 patients with mild Alzheimer’s disease is comparing solanezumab with a placebo, and its outcome will determine whether Lilly submits the drug for marketing approval in the USA and elsewhere. The results of that trial should be made available in 12 to 18 months. Only patients with mild dementia were measured.
Findings from industry studies of three alternative antibody therapies were presented at the Alzheimer’s Association global conference in Washington.
He said: “What happened is, in the people who didn’t get the drug, the people on a placebo, there was a deterioration in their disease, as we would anticipate”.
Results from the drug’s trial have been kept secret, however Eli Lilly researchers have said previously: “Results from 28 weeks’ treatment suggest patients who received Solanezumab had a cognitive benefit not recovered by patients who began Solanezumab later”.
However, he also warned that although the results leaned towards a treatment that could slow the disease, the drug aducanumab was not without side effects. According to Alzheimer’s Research United Kingdom, people with the disease also have a shortage of some chemicals in their brain.
“As clinical studies become more complex, there is a growing need for real-time and standardized data and analytics from multiple studies”, said Xavier Flinois, President, PAREXEL Informatics. And Imperial College claims to have discovered how to turn off an enzyme which is driving many incurable diseases including Alzheimer’s and cancer.
However, the trial was terminated earlier this year by Roche, as it was considered unlikely to find any significant effect on cognition. The number of people affected by dementia is expected to be more than 75 million in 2030 and 135 million in 2050. “The cognitive benefits are not astounding”.
In other Eli Lilly and news, major shareholder Lilly Endowment Inc sold 210,000 shares of the stock in a transaction dated Wednesday, June 10th. To better assess whether mildly impaired patients benefit from the drug, Lilly extended its two trials by another two years and only enrolled those with mild disease.
“These results support the trial design and delayed-start analysis plan of Expedition 3, which is expected to have the last patient visit in October 2016”.