Eli Lilly officials report that solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a Phase III study of the drug in people with mild dementia due to Alzheimer's disease (AD). Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo (p=0.095), as measured by the ADAS-Cog14 (Alzheimer's Disease Assessment Scale-Cognitive subscale).
While the study results, including many secondary clinical endpoints, directionally favored solanezumab, the magnitudes of treatment differences were small, according to the company. There were no new safety signals identified in the study. Lilly will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer's disease.
“The results of the solanezumab EXPEDITION3 trial 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,” said John C. Lechleiter, Ph.D., chairman, president and CEO, Lilly. “We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer's pipeline assets.”
Lilly will work with investigators to appropriately conclude the open-label extensions for EXPEDITION, EXPEDITION2, and EXPEDITION3. The next steps for the remaining elements of the solanezumab development program have not yet been determined.
“Lilly has strong growth prospects without solanezumab,” added David A. Ricks, Lilly's incoming CEO and president of Lilly Bio-Medicines. “Driven by new product launches, we continue to expect to grow average annual revenue by at least 5% between 2015 and 2020. Over that time frame, we also expect to increase our margins and provide annual dividend increases to our shareholders.”
The EXPEDITION3 study outcome is expected to result in a fourth-quarter charge of approximately $150 million (pre-tax), or approximately $0.09 per share (after-tax). The company will provide updated 2016 financial guidance and announce its 2017 financial guidance on December 15, 2016, and will also conduct a conference call with the investment community and media at 9:00 a.m. ET on that date.
According to analysts Paul Matteis and Jeffrey Lin, Ph.D., at Leerink, “the study showed (likely a very small) trend on cognition (p=0.095). We remain cautiously optimistic that [AC Immune’s] crenezumab, with a binding profile similar to [Biogen’s] aducanumab and much higher dosing, continues to have a shot at success in the ph3 CREAD study, though solanezumab details at CTAD [Alzheimer’s trial] will be important for the β-amyloid hypothesis.”