Eli Lilly has enrolled the last patient in its EXPEDITION3 trial of beta amyloid-targeting antibody solanezumab, and says it should be ready to unveil the top-line result from the study in December.
If the results are positive it would represent a step forward in the treatment of Alzheimer's as well as a great parting gift for Lilly's chief executive John Lechleiter, who will retire at the end of the year after leading the company for eight years.
There is no doubt that given the huge number of anti-amyloid drugs that have failed in trials solanezumab is a high-risk project, but Lilly's CEO-in-waiting David Ricks said that while it is possible that the drug will perform no better than placebo, he considers that the "least probable outcome". The company hasn't seen any preliminary data from the trial however.
A win in the EXPEDITION3 trial could lead to rapid regulatory filings, said Ricks, and if approved could be a massive product for Lilly with analysts forecasting recently that sales could reach up to $7.5bn at peak.
Many scientists continue to believe that amyloid is the main pathogenic factor responsible for the degenerative changes that occur in the brain during Alzheimer's, and if solanezumab does show any efficacy, it would be the first drug to support that hypothesis in a late-stage trial.
Solanezumab failed to show a clear benefit in trials involving patients with more advanced Alzheimer's, but led to speculation that amyloid needs to be blocked early in the course of the disease in order to prevent the formation of plaques that seem to cause the neuronal damage that in turn leads to cognitive and memory decline.
The company recently began another phase III trial of solanezumab in prodromal (very early) Alzheimer's that will have 2,500 subjects when fully enrolled. Results from that trial are due in 2021. Ricks said that if EXPEDITION3 is a bust the prodromal trial will probably be abandoned.
The comments on solanezumab came during Lilly's third-quarter results call, in which it reported a sales increase of 5% to $5.2bn driven by new product launches.
Among these, diabetes drugs Trulicity (dulaglutide) and Jardiance (empagliflozin) both saw solid sales gains that did not however meet analysts' expectations, while lung cancer therapy Cyramza (ramucirumab) fell 12% thanks to competition from immuno-oncology rivals, Merck & Co's Keytruda (pembrolizumab) and Bristol-Myers Squibb's Opdivo (nivolumab).
Initial sales of Taltz (ixekizumab), which was approved by the FDA in March for the treatment of adults with moderate-to-severe plaque psoriasis, were $33m. The interleukin-17 (IL-17) inhibitor is chasing Novartis' Cosentyx (secukinumab), which has the same mechanism of action and made $301m in the third quarter.