The recent Alzheimer’s disease drug trials results have led to disappointment among innovators and patients.
On November 25, 2024, Cassava Sciences, Inc. announced that their innovation Simufilam aimed at the treatment of Alzheimer's Disease has failed to meet the primary end-points in the phase 3 clinical trial. The 52-week trial has led to disappointment and the company decided to discontinue the trial.
On the same day, Alector, Inc. announced the results from phase 2 clinical trials of AL002 which is aimed at slowing the progression of early Alzheimer’s disease. The drug has failed to meet the primary endpoint of slowing Alzheimer’s clinical progression as measured by the Clinical Dementia Rating Sum of Boxes. As a result of trial failure, Alector laid off 17% of its work staff to focus on organizational goals.
Which novel therapies are on rescue?
Lecanemab (Leqembi) and donanemab (Kisunla) are the two promising disease-modifying therapies, which were recently approved for mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease. These are considered as anti-amyloid monoclonal antibodies.
Why these drugs are different and why they are gaining traction in Alzheimer’s disease therapeutics market?
- Lecanemab mainly targets Aβ protofibrils which are highly neurotoxic and are main therapeutic targets in Alzheimer’s disease. This novel therapy reduces the Aβ plaques in dose and time dependent manner.
- Donanemab targets N3pG amyloid beta epitope that is localized to deposited amyloid plaques. This therapy removes the existing cerebral amyloid plaque through microglial-mediated phagocytosis in dose and time dependent manner.
Both the drugs are found to reduce the cognitive decline upto 30% in Alzheimers patients. The other approved drugs such as donepezil, rivastigmine, galantamine, memantine focus on treating the cognitive impairment, rather than the underlying cause.
Who are the innovators behind these anti-amyloid monoclonal antibodies?
What is their market performance and future growth?
Eisai Alzheimer drug “Leqembi” is the first one to hit the market, and have already started generating sales. The company has reported a revenue growth of 108.1% from Leqembi in the previous financial year. The company also aims to generate a sales value of approximately US$ 300 million in the next financial year (April 1 2024 to March 31, 2024.) whereas lilly Alzheimer drug “kisunla” has just hit the market, and is yet to gain traction. Eli lilly has not reported the revenue for kisunla yet, but DataM estimates the similar revenue generation like Leqembi in the next fiscal year.
What is the projected market growth for these anti-amyloid monoclonal antibodies?
DataM estimates a revenue generation close to 4.9 billion in 2030, and 5.65 billion in 2031, for these two therapies. The compound annual growth rate between 2024 and 2031 is expected to be 34.8%.
