Eli Lilly’s drug slows Alzheimer’s progression in promising results

Pharma News: Eli Lilly Australia joined medical experts and the dementia community to hail a breakthrough in the fight against Alzheimer’s disease. Today, at the Alzheimer’s Association International Conference (AAIC) 2023, the company unveiled international research on the efficacy and safety of their biologic medicine, Kisunla (donanemab).

Kisunla, a monoclonal antibody specifically designed to clear brain amyloid plaque in Alzheimer’s disease, has shown potential to transform the lives of those affected by this devastating condition. The results from the TRAILBLAZER-ALZ 2 Phase III clinical trial have ignited excitement and hope among the medical community and dementia advocates alike.

Dementia Australia CEO Maree McCabe AM expressed her enthusiasm for this advancement, declaring it as a crucial step forward in expanding the range of dementia treatments.

“These results provide much-needed hope for people experiencing symptoms, mild cognitive impairment, or in the early stages of Alzheimer’s disease,” said Ms McCabe.

With dementia ranking as the second leading cause of death in Australia and the leading cause of death among Australian women, this breakthrough promises to have a significant impact on the lives of patients and their families.

The study, which assessed the effects of donanemab on over 1,700 individuals with early symptomatic Alzheimer’s disease, revealed positive outcomes. Donanemab demonstrated a clinically meaningful benefit (considered to be >20% slowing of clinical progression) on cognitive and physical functioning scales. Study participants at the earliest stage of disease had greater benefit, representing a 35.1% slowing of disease progression (P < .001) at 18 months. Additionally, nearly half (47%) of study participants at the earliest stage of disease had no clinical progression at one year.

“With this fuller picture, there is additional, convincing scientific evidence that thoroughly removing beta amyloid from the brain is associated with significant slowing of disease progression in people living with early Alzheimer’s,” said Dr Maria Carrillo, Alzheimer’s Association Chief Science Officer during AAIC.

“The results illustrate that initiating treatment as early as possible enables the possibility of a bigger beneficial effect, but also that there is potential for slowing of disease progression even when treatment is started later in the disease progression,” Dr Carrillo said. “These benefits are real and meaningful, giving people more time to participate in daily life, remain independent and make future health care decisions,” she added.

Eli Lilly confirmed that a regulatory submission to the Therapeutic Goods Administration (TGA) is imminent, with plans to apply for a Pharmaceutical Benefits Scheme (PBS) listing underway.

Tori Brown, General Manager of Eli Lilly Australia & New Zealand, stressed the urgent need for early diagnosis and treatment.

“Our hope is that this research will act as the catalyst for change in Australia because our current healthcare system is not equipped to support early and accurate detection and diagnosis of Alzheimer’s disease. We need urgently to remove the barriers to timely diagnosis and optimal care of Australians living with Alzheimer’s disease as part of the national aged care agenda,” she said.

In June this year, the TGA also commenced evaluating an application to register Eisai’s Leqembi (lecanemab) in Australia. After 18 months of follow-up, people with early-stage Alzheimer’s disease receiving Leqembi demonstrated a slower rate of cognitive decline (by 27%) compared to those who received the placebo. The Leqembi group also showed a greater reduction in amyloid levels in the brain from baseline at 18 months compared with placebo.

Chair of Dementia Curtin University and Dementia Australia Professor Blossom Stephan said the results of the TRAILBLAZER-ALZ 2 trial were encouraging.

“This research highlights the need to ensure that healthcare services are equipped to deliver the intervention as well as make sure that access to treatment is equitable and available to everyone,” Professor Stephan said.

Dementia Australia advocate Bill Yeates, who was diagnosed with younger-onset dementia in 2019, was among those praising the remarkable results.

“This demonstrates that it is possible to significantly slow down cognitive decline through the removal of amyloid beta from the brain. For me, it’s that ‘ray of hope’ that I believed would happen one day, where people living with dementia can have a future. One where you can lead a better life, one that you value,” he commented.

Dementia Australia estimates more than 400,000 Australians are living with the disease as of 2023. It is the second leading cause of death of all Australians and is the leading cause of death for women.

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