NA-831 combination regimen is being assessed for treating Alzheimer’s disease. Credit: Clément Falize on Unsplash.

Biomed Industries has published a protocol for a Phase III clinical trial of the new NA-831 combination therapy for Alzheimer’s disease (AD).

The placebo-controlled, double-blind, parallel-group trial will assess the safety and efficacy of NA-831 in conjunction with Lecanemab.

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Lecanemab is an FDA-approved medication for early-onset AD.

NA-831 is an experimental drug that has already shown promise in earlier clinical phases.

An orally administered small molecule, it is said to be associated with cognitive improvements in patients with mild cognitive impairment (MCI) and mild to moderate Alzheimer’s disease.

Biomed Industries CEO Dr Lloyd Tran said: “It is time to address both the underperformance of current AD drugs on the market and their serious side effects by seeking new treatment modalities.

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“We believe that by significantly reducing the dosage level of anti-amyloid drugs and leveraging the promising cognitive benefits of NA-831, we can offer new hope to patients suffering from this devastating disease.”

Results from the Phase II trial of NA-831 have been encouraging, with patients demonstrating an average improvement of 3.4 and 4.1 points on the ADAS-Cog-13 score, a measure of cognitive function, over a 24-week treatment period.

The drug was administered at a dosage of 30mg/day and was well-tolerated, with no serious adverse events reported.

Biomed Industries business development vice-president Michael Willis said: “Biomed’s robust Phase II and Phase II pipeline spans Alzheimer’s Disease, ALS, major depressive disorder, Rett Syndrome, stroke, obesity, and liver disease MASH.

“Our pioneering efforts in integrating human and artificial intelligence expedite drug discovery to meet patient needs.”