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news.US-based biopharmaceutical firm Alzheon has released positive data from Phase I clinical trial of ALZ-801, a first-in-class small molecule inhibitor of amyloid formation and neurotoxicity to treat Alzheimer’s disease (AD).
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As additional support to the clinical program for ALZ-801, the company had reported expanded post-hoc analyses of Phase III data with tramiprosate.
Tramiprosate is the parent molecule of the optimized prodrug ALZ-801, which showed sustained efficacy on cognition and function in a population of patients with AD that are positive for the e4 gene variant of apolipoprotein E (ApoE4), associated with increased risk of AD.
In the Phase I single ascending dose trial, ALZ-801 reduced the inter-subject pharmacokinetic variability that hindered the efficacy signal of tramiprosate in the previous Phase III trials.
A total of 67 healthy elderly subjects were included in the Phase I trial and ALZ-801 showed an extended half-life of 14.9 hours, showing extended bioavailability to allow efficient once-daily dosing.
Additionally, ALZ-801 showed improved gastrointestinal tolerability as measured by reduced incidence of nausea and vomiting, and also decreased inter-subject pharmacokinetic variability, compared to the parent molecule, tramiprosate.
The company has also conducted expanded post-hoc analyses and reported results from the North American Phase III trial of tramiprosate, which analyzed 599 AD patients from the Phase III trial with heterozygous or homozygous ApoE4 genotype.
The analyses showed that homozygous ApoE4-positive AD patients who received twice-daily administration of 150mg tramiprosate showed a greater than 4-point improvement in ADAS-cog at 78 weeks, compared to the placebo group.
The company is accelerating the clinical development program of ALZ-801 based on the positive results and findings from these clinical trials in order to confirm the dose regimen for a planned pivotal Phase II/III trial in a defined population of ApoE4-positive patients with AD.
Alzheon chief scientific officer John Hey said: "With ALZ-801, Alzheon has an exciting new molecule with compelling clinical rationale as a late-stage drug candidate for Alzheimer’s disease.
"We are highly encouraged by the Phase 1 data which met our criteria for demonstrating optimized drug properties of ALZ-801 over tramiprosate, as well as strong therapeutic profile.
"Additionally, our extensive analyses of the previous Phase 3 dataset of tramiprosate further clarify and focus our clinical plan as we advance ALZ-801 toward a Phase II/III pivotal study later this year."