Anavex Life Sciences will be submitting an application to the European Medicines Agency (EMA) for approval of its Alzheimer’s disease candidate, despite only meeting one of the two co-primary endpoints.
The US-based company will ask the EMA for approval before the end of 2024 after a Phase IIb/III study (NCT03790709) showed that blarcamesine, a once-daily oral drug, significantly slowed clinical decline in people with early Alzheimer’s disease.
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The company has not mentioned any approval plans with the US Food and Drug Administration (FDA).
Anavex’s investors seem satisfied by the company’s 29 July announcement, with the stock price due to rise by 11.13% when the markets open, from a 26 July close of $6.74 to a predicted opening price of $7.49 on 29 July.
The data will be presented by neurology professor Marwan Noel Sabbagh, Barrow Neurological Institute at the 2024 Alzheimer’s Association International Conference (AAIC) taking place in Philadelphia between 28 July and 1 August.
In the study, blarcamesine significantly slowed clinical progression by 38.5% and 34.6% at 48 weeks in 50mg and 30mg groups versus placebo, respectively, on the prespecified primary cognitive endpoint Alzheimer’s disease assessment scale–cognitive subscale 13 (ADAS-Cog13).
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By GlobalDataThe second co-primary endpoint of activities of daily living scale (ADCS-ADL), was trending positive but did not reach significance. Anavex is questioning whether this miss is due to the scale being less sensitive for early Alzhimer’s disease.
The prespecified key secondary composite endpoint clinical dementia rating sum of boxes score (CDR-SB) was also significant in both dose groups. This endpoint was recommended as an alternative primary endpoint for early Alzheimer’s disease in the new FDA guidance.
In the same March 2024 FDA Guidance for Early Alzheimer’s disease, a sole cognitive measure can serve as the primary endpoint for early Alzheimer’s trials.
Dr Sabbagh said: “We believe the scalable and convenient features of blarcamesine could reduce crucial barriers within the currently complex healthcare ecosystem for Alzheimer’s disease and provide broader access to a diverse population with early Alzheimer’s disease.”
Blarcamesine is a sigma 1 receptor and M1-M4 muscarinic agonist and binds the sigma-1 receptor in the high nanomolar and the muscarinic receptor in the low micromolar range. It is also being investigated in Rett Syndrome and Parkinson’s disease.
The Phase IIb/III trial enrolled 509 patients across sites in Australia, Canada, and Europe. Patients were monitored for 48 weeks of the once-daily oral drug.
Alzheimer’s disease landscape
The Alzheimer’s disease treatment landscape currently remains dominated by anti-amyloid therapies, including Eisai and Biogen’s lecanemab marketed as Leqembi, and recently approved Kisunla (donanemab) from Eli Lilly.
There was a third anti-amyloid therapy on the market, Biogen’s Aduhelm (aducanumab) however it was pulled from the market some months after Medicare limited coverage of the drug after cases of brain swelling and bleeding.
There are several other notable Alzheimer’s disease drugs in late-stage trials, including Cassava Sciences simufilam hydrochloride of which data is expected by the end of this year.
Other developments in the Alzheimer’s disease space include the development of a blood test to detect amyloid and tau, with several companies due to present data at the AAIC.
