High expectations and hopes surrounded Eli Lilly and Company's drug solanezumab. Solanezumab is a humanized monoclonal IbG1 antibody, and it was targeting an amyloid beta peptide with the goal of slowing the effects of Alzheimer's disease.
But the promise shown in early phases of research was not shown during a third phase of testing, Lilly announced recently. The company has no plans to seek regulatory approval for the drug.
During the Phase 1 study, solanezumab was demonstrated to be well tolerated, and 33 patients with mild to moderate Alzheimer's disease responded with biomarker changes in amyloid. Phase 2 confirmed the safety and tolerability of the antibody after a 12-week study.
There were two trials in Phase 3 — Expedition 1 and 2 — involving 2,052 patients with mild to moderate Alzheimer's disease. They received infusions of solanezumab or a placebo once per month over 80 weeks.
However, Lilly announced that solanezumab had not met the criteria for success and did not experience a statistically significant slowing in cognitive decline when compared the placebo. The endpoint was measured by the Alzheimer's Disease Assessment Scale (ADAS-Cog14).
"The results ... were not what we had hoped for, and we are disappointed for the millions of people waiting for a potential disease-modifying treatment for Alzheimer's disease,"
But hope is not lost.
In the drug category of treatments targeting the immune system, monoclonal antibodies like solanezumab have been considered by other research groups for the treatment of Alzheimer's disease, and there still is hope with these drugs. Monoclonal antibiotics imitate the antibodies occurring naturally as part of the body's immune system and their reaction to foreign matter.
Biogen has a drug under investigation for treatment or early Alzheimer's disease — aducanumab — and it was granted fast-track designation by the U.S. Food and Drug Administration this fall. This drug is now in Phase 3 study status, and the hope is that it will prove to be effective in the treatment of Alzheimer's disease.
No one wants any of these drugs to fail. Given the toll that Alzheimer's disease takes on patients and their families, success is crucial. But with a failure to show effectiveness, a company must move on.
"Lilly is grateful for the dedication of the patients, their families and the clinical investigators who participated in this study," said Jan Lundberg, Ph.D., executive vice president of science and technology and president of Lilly Research Laboratories. "Lilly remains committed to Alzheimer's research as we have been for nearly 30 years, and our portfolio includes many other promising approaches."
With such commitment, success will eventually come.
