- Eli Lilly & Co. (NYSE:LLY) has announced full results from its Phase 3 TRAILBLAZER-AL-3 study
- The study has shown slowed progression of early stage Alzheimer’s by 35 per cent
- The company is now seeking approval from the U.S. Food and Drug Administration (FDA) For the treatment
- Shares of Eli Lilly & Co (NYSE:LLY) are down 2.5 per cent to US$446.90 as of 3:17 p.m. ET
Eli Lilly & Co. (NYSE:LLY) announced a breakthrough for Alzheimer’s Disease treatments on Monday.
The pharmaceutical giant released full results from its Phase 3 TRAILBLAZER AL-3 study, which has shown slowed progression of early stage Alzheimer’s disease by 35 per cent.
The company presented its results at the Alzheimer’s Association International Conference in Amsterdam, while experts in the field called Eli Lilly & Co.’s presentation a significant milestone for the field.
The treatment, which is known as donanemab, showed in the study that it drastically slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease.
“If approved, we believe donanemab can provide clinically meaningful benefits for people with this disease and the possibility of completing their course of treatment as early as 6 months once their amyloid plaque is cleared,” Anne White, executive vice president of Eli Lilly & Co, said in a statement.
Significant results from the study showed that the treatment slowed cognitive and functional decline for amyloid-positive early symptomatic Alzheimer’s disease patients. The treatment was proven to lower the risk of disease progression while nearly half the patients at the earlier stage of disease on donanemab had no clinical progression at the one-year mark.
The trial enrolled a little more than 1,700 patients at an average age of 73 with mild to moderate symptoms of Alzheimer’s.
Half of the patients received IV infusions of donanemab while the other half received a placebo every four weeks for 18 months.
White added that this is the first Phase 3 study of a disease-modifying therapy to replicate the positive clinical results shown in a previous study.
Eli Lilly & Co. first reported in May that donanemab slowed cognitive and functional decline in patients with early Alzheimer’s disease.
At the time, the treatment had met the primary endpoint of change from baseline to 18 months on the integrated Alzheimer’s Disease Rating Scale (iADRS). The primary endpoint of iADRS measures cognition and daily activities such as managing financing, engaging in hobbies, conversing about current events and driving.
The company said it expects to have the treatment approved by the U.S. Food and Drug Administration (FDA) this year.
Future of Alzheimer’s disease treatments
Once Eli Lilly & Co.’s treatment notches approval, it’ll be the second one available after the FDA approved Biogen’s (NASDAQ:BIIB) LEQEMBI treatment earlier in July.
So far, LEQEMBI is the first and only approved treatment shown to reduce the rate of Alzheimer’s disease progression and slow cognitive and functional decline in patients with the disease.
Moving forward, the Alzheimer’s disease treatment market is expected to reach a valuation of $7.35 billion by 2030, up from $3.05 billion in 2023 and growing at a compound annual growth rate of 9.2 per cent.
Fueling the market growth will be a demand for effective Alzheimer’s disease treatments and the increased number of patients with the condition.
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