- AstraZeneca and Eli Lilly will advance their jointly developed early Alzheimer's disease drug into Phase 3 trials after positive safety data was reported, the companies said on Friday.
- The drug, called AZD3293, is part of a class of drugs known as BACE inhibitors, which have shown some promise in slowing the progression of the disease.
- The companies began collaborating on AZD3293 in 2014, with Lilly taking the lead in clinical development and AstraZeneca responsible for manufacturing. Reaching Phase 3 testing triggers a $100 million milestone payment to AstraZeneca from Lilly.
BACE (beta secretase cleaving enzyme) inhibitors aim to halt disease progression by preventing the formation of amyloid plaque in the brain. Pieces of protein called amyloid beta can clump together and form plaques which are associated with the development of Alzheimer's. In Phase 1 studies, AZD3293 reduced levels of amyloid beta in the cerebro-spinal fluid of both people with the disease and health volunteers.
Alzheimer's drug development is particularly challenging, however, and numerous drugs have failed to show efficacy in treating the disease.
“Alzheimer’s disease remains one of the biggest challenges facing medical science today. BACE inhibitors have the potential to target one of the key drivers of disease progression and we are delighted that our combined efforts have resulted in the development of AZD3293 moving into the next phase of study," said Menelas Pangalos, executive vice president of AstraZeneca's IMED Biotech unit.
The current trial, called Amaranth, is a seamless Phase 2/3 trial. The interim safety analysis recommended the study continue without any changes to design. AstraZeneca and Lilly hope to enroll over 2200 patients across 14 countries by the time the study is complete.
In addition to Amaranth, the companies also announced they would begin another Phase 3 trial to examine the drug's safety and efficacy in treating mild Alzheimer's dementia. This second trial will begin in Q3 2016.
Given the struggles of other Alzheimer's drugs, sharing development costs makes sense for AstraZeneca and Lilly. Under their collaboration agreement, both companies have joint responsibility for commercialization and will share net global revenues equally if the drug makes it to market.
Other companies are eager to test the potential of BACE inhibitors as well. Novartis and Amgen are working together on one compound, while Merck and Johnson and Johnson are going at it alone. So far, Merck appears furthest along, expecting a primary completion date for its Epoch study in July 2017, according to EP Vantage.