Lilly’s Donanemab Displays Surprising Benefits for Younger Patients: New Data Analysis Reveals Positive Effects

Eli Lilly has made the exciting announcement of full results for their Phase III TRAILBLAZER-ALZ 2 study of donanemab, confirming the positive results previously published in May. After months of anticipation, this news can help lead the way in the fight against Alzheimer’s disease. With this promising advance, those affected by this debilitating condition have another hope on the horizon.

The findings from a comprehensive data set, containing subpopulation analyses, have been published in the Journal of the American Medical Association. These results offer greater insight into important demographic groups and provide a detailed overview of the full data set.

MAY REPORT: Cognitive decline could be reduced by up to 35% in older adults with low-medium levels of tau, a key protein that plays a role in Alzheimer’s disease, according to a recent study. When compared to the use of placebo treatment, the decline on the Integrated Alzheimer’s Disease Rating Scale (iADRS) and the Clinical Dementia Rating-Sum of Boxes (CDR-SB) was seen to decrease by up to 36%. Across all amyloid-positive early symptomatic participants, these numbers showed a reduction of 22% and 29%, respectively.

Participants in the earliest stages of Alzheimer’s Disease in the study noted a remarkable 60% reduction in decline in just one year thanks to treatment, based on pre-defined subpopulation analyses.

The benefit was even more remarkable in younger participants under 75 years – they experienced a 48% slowing of decline on the iADRS and a 45% improvement on CDR-SB compared to participants over 75 years, who only saw a 25% improvement on the iADRS and 29% on the CDR-SB.

The safety of anti-amyloid antibodies—including donanemab and Eisai and Biogen’s Leqembi—continues to be an ongoing challenge due to the presence of amyloid-related imaging abnormalities (ARIA) in 37% of donanemab-treated patients, tragically resulting in three deaths.

The findings of this groundbreaking research point to anti-amyloid therapies being the critical first step in treating Alzheimer’s disease, according to Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation. With the power of cutting-edge science, and this medical breakthrough, we are one step closer to finding an effective treatment to help those suffering from this devastating disease.

Lilly has recently submitted donanemab to the FDA for traditional approval, and they anticipate a verdict by the end of 2023. A speedy resolution to this process would be a significant milestone as Lilly endeavours to make this revolutionary treatment available to those in need.

Alzheimer’s Leaders Converge at AAIC in Transitional Moment for the Space

This week, drug developers for Alzheimer’s treatments will convene in Amsterdam for the 2023 Alzheimer’s Association International Conference, where Eisai will discuss the approved drug Leqembi as well as updates on Eli Lilly’s donanemab. Attendees will be eager to hear what Eisai has to say and to learn more about the progress of research and development for potential Alzheimer’s treatments.

Eisai is set to share five lively presentations on Leqembi (lecanemab) at an up and coming event, featuring promising data that the subcutaneous form of the drug could offer comparable efficacy and improved safety over the intravenous version in early Alzheimer’s disease. The Phase I trial of healthy volunteers is testing out the single dose of subcutaneous lecanemab, so watch this space for exciting results.

Eisai recently presented the results of a Phase I clinical study showcasing the potential of its novel anti-microtubule binding region (MTBR) tau antibody, E2814. Michael Irizarry, deputy chief clinical officer and senior vice president of clinical research for Alzheimer’s disease and brain health at Eisai, revealed that with increasing doses of the antibody, a notable increase in levels of measurable tau species in the cerebrospinal fluid can be observed. This gives promising insights to the target engagement and downstream effects of E2814 use.

At the upcoming conference, this week, John Irizarry is set to announce an exciting new development in the staging of Alzheimer’s disease. The current stages, which are largely focused on amyloid, tau, and neurodegeneration, can now be further segmented into early and later tau stages. This progress is made possible by new biomarkers in cerebrospinal fluid and plasma, as well as advances in tau positron emission tomography (PET) imaging.

By closely monitoring the pharmacodynamic effects of their tau antibody, Irizarry and his team have been able to gain valuable insight into the efficacy of the product. This has proven to be immensely helpful in determining the success of the antibody’s development.

At the AAIC, attendees will be eagerly awaiting an update from Eli Lilly on the late-stage clinical trial of their Alzheimer’s therapy, donanemab. The company will host a webcast on Monday at 1:30 pm EST to provide an update on the Phase III TRAILBLAZER-ALZ 2 study and engaged participants are eagerly anticipating the news.

In May, Lilly revealed the results of their trial using donanemab, with an impressive 35% reduction in cognitive and functional deterioration compared to the placebo, in patients with intermediate levels of the tau protein and clinical symptoms of Alzheimer’s as measured by the integrated Alzheimer’s Disease Rating Scale (iADRS). Researchers eagerly await further analysis of the findings to further understand their implications.

At the upcoming Alzheimer’s Association International Conference (AAIC), the expectation is that more details about the data from donanemab will be revealed. According to Professor Constantine Lyketsos of the Johns Hopkins University School of Medicine, all that has been revealed so far is a high-level press release.

The anticipation to hear more information about the data is rising, as donanemab could be the potential new Alzheimer’s breakthrough that researchers around the world have long been awaiting.

The U.S. Food and Drug Administration (FDA) recently rejected Eli Lilly and Co.’s application for accelerated approval of donanemab, citing concerns over trial design in its Complete Response Letter.

Despite this setback, the pharmaceutical giant has declared its intentions to resubmit the drug this quarter in the hopes of finally receiving the FDA’s approval. All eyes are now waiting for the announcement of Lilly’s next move to see if it can bring this innovative drug to market.

Athira Pharma is set to unveil exciting findings this Wednesday – biomarker analysis of their experimental small molecule, Fosgonimeton. This molecule is designed to fortify the activity of hepatocyte growth factor, and it’s receptor mesenchymal-epithelial transition – a natural repair mechanism in the nervous system.

This follows the ACT-AD clinical trial results from the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference in November 2022, which showcased a decrease in the biomarkers of neurodegeneration and neuroinflammation.

Athira Pharma’s upcoming presentation promises to shed further light on this novel healing approach and its potential to combat neuroscience diseases.

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