Biogen’s controversial approval of its anti-amyloid Alzheimer’s disease (AD) drug Aduhlem may have irked many specialists, but it has created a boon and fresh optimism in companies with similar drugs in the pipeline.
Roche is one, saying this week it is mulling over with the FDA whether its failed AD drug could in fact seek a path to approval, and Lilly is now also trying the same tact with its hopeful donanemab.
The drug is a little different to Roche’s and Biogen’s assets as it works as an active immunotherapy designed to stimulate the patient’s immune system to attack and destroy beta amyloid plaques that are believed to form in the brain and spur the memory-wasting disease.
It boasted of a trial win at the start of the year saying it could show “significant slowing of decline.” But when further data were revealed, key secondary endpoints were missed, and the mixed bag of data seemed to lean Lilly toward putting at the back of its pipeline cupboard.
But the unexpected FDA approval of Aduhlem appears to have spurred Lilly back into action, and its gunning full speed ahead with a phase 3 trial, known as TRAILBLAZER-ALZ 3, to fully assess whether donanemab can slow the clinical progression of Alzheimer's disease in trial participants.
To help with the trial, Lilly is teaming up with the Banner Alzheimer's Institute, a 15-year-old organization that is seeking to help find treatments and prevention for the memory-wasting disease, to help seek subjects that either have, or do not have, the e4 type of the apolipoprotein E (APOE4) gene, which it will find via its Alzheimer's Prevention Registry's GeneMatch program. This gene is believed to be a biomarker for an increased risk of the disease,
The collab will also “introduce a more virtual approach to the evaluation of Alzheimer's prevention therapies,” the pair said in a joint statement.
“This collaboration combines Lilly's more than 30 years of dedication to Alzheimer's research with Banner's unique expertise and showcases our collective commitment to partner within the health care community to find potential treatments to end this devastating disease,” said Mark Mintun, M.D., vice president of pain and neurodegeneration, Lilly.
“Our TRAILBLAZER-ALZ 3 trial will evaluate whether donanemab can prevent clinical progression in patients who have evidence of Alzheimer's pathology, but don't yet demonstrate clinical symptoms. While these types of trials are challenging to enroll and conduct, Lilly, together with Banner, is proud to undertake the opportunity to bring about this new study in an area of high unmet medical need."
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"We are excited about the chance to work with Lilly in the effort to find an effective Alzheimer's prevention therapy as soon as possible, introduce novel ways to increase the size, speed, and ease of participating in Alzheimer's prevention trials, and do so in ways that might benefit the entire field," added Eric Reiman, M.D., Banner Alzheimer's Institute executive director and one of the study's lead principal investigators.
“We must do everything we can to find and support the availability of effective prevention therapies for this devastating disease, and this trial includes several potentially transformational elements to help in this endeavor.”