Hopes dashed for new Alzheimer drug
Lilly's solanezumab fails to meet primary endpoint of Phase III study.
Eli Lilly has announced that solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a phase 3 study of solanezumab 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 with patients treated with placebo, as measured by the ADAS-Cog14 (Alzheimer's Disease Assessment Scale-Cognitive subscale).
While the study results, including many secondary clinical endpoints, directionally favoured solanezumab, the magnitudes of treatment differences were small. 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, 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 is grateful for the dedication of the patients, their families, and the clinical investigators who participated in this study," said Jan Lundberg, 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."
Lilly will present further findings from the study at the Clinical Trials on Alzheimer's Disease (CTAD) meeting on Thursday, 8 December at 9:15 p.m. ET. The presentation will be shared live via webcast from the meeting.
"Lilly has strong growth prospects without solanezumab," said David A. Ricks, Lilly's incoming chief executive officer 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."
Related News
-
News Understanding the Benefits and Advances of Cleanroom Technology
In an industry where precision and sterility are crucial concerns, cleanrooms play a vital role in maintaining the integrity of pharmaceutical products like drugs, vaccines, and other medical products. So, what is a cleanroom?
-
News AbbVie secures GBP£1.2 billion deal for Gilgamesh’s psychedelic programme
AbbVie has penned a significant agreement to acquire the bretisilocin programme from Gilgamesh Pharmaceuticals for up to £1.2 billion, marking a bold step in the pharmaceutical giant's quest to develop treatments for psychiatric disorders. -
News Gates Foundation commits US$2.5 billion to women’s health research
The Bill & Melinda Gates Foundation has announced a substantial US$2.5 billion commitment to accelerate research and development focused exclusively on women's health through 2030.
-
News Mid-year review: notable FDA drug approvals of 2025
As we fly past the halfway point of 2025, the pharmaceutical landscape reliably continues to evolve with innovative therapies addressing critical medical needs. The FDA has already approved 17 groundbreaking medications this year, each representin... -
News US FDA announces new priority vouchers for accelerated review times
The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening th... -
News Google-backed start-up raises US$600 million to support AI drug discovery and design
London-based Isomorphic Labs, an AI-driven drug design and development start-up backed by Google’s AI research lab DeepMind, has raised US$600 million in its first external funding round by Thrive Capital. The funding will provide further power t... -
News AstraZeneca to invest US$2.5 billion in Beijing R&D centre
Amid investigations of former AstraZeneca China head Leon Wang in 2024, AstraZeneca have outlined plans to establish its sixth global strategic R&D centre in China. Their aim is to further advance life sciences in China with major research and manufact... -
News Experimental drug for managing aortic valve stenosis shows promise
The new small molecule drug ataciguat is garnering attention for its potential to manage aortic valve stenosis, which may prevent the need for surgery and significantly improve patient experience.