Alpha Cognition has announced positive results from a bioequivalence study with ALPHA-1062 for the treatment of mild-to-moderate Alzheimer’s disease (AD).
The biopharma, which focuses on developing novel therapies for neurodegenerative disorders, designed the study to demonstrate pharmacokinetic equivalence between 5mg ALPHA-1062 delayed release tablets and 8mg galantamine hydrobromide extended release (ER) capsules – the current standard of care treatment for patients with mild-to-moderate AD.
Galantamine has been associated with gastrointestinal adverse events including nausea, vomiting and decreased appetite. ALPHA-1062, however, is a delayed release pro-drug of galantamine, uniquely designed to reduce gastrointestinal adverse effects by remaining inert as it passes through the stomach.
The study randomly assigned 40 subjects to receive ALPHA-1062 or galantamine hydrobromide ER. After taking the assigned drug once a day for seven days, participants stopped dosing and, after a washout period, started taking the other medicine.
Topline results confirmed that in healthy adult volunteers treated to steady their state, ALPHA-1062 was bioequivalent to galantamine hydrobromide ER. Moreover, in the pre-specified primary analysis, ALPHA-1062 achieved area-under-the-curve and peak exposures of approximately 107% and 127%, respectively, compared to those generated by galantamine hydrobromide ER.
The results, along with positive pivotal data released in June evaluating galantamine hydrobromide’s immediate release (IR) ‘strengthen the New Drug Application (NDA) for ALPHA-1062 in mild-to-moderate AD, planned for the second quarter of 2023,’ the company said.
According to the Alzheimer’s Society, in 2019, there were over 850,000 people with dementia in the UK, representing one in every 14 of the population aged 65 years and over. If current trends continue with no action taken, the number of people with dementia is predicted to increase to around one million by 2025, rising to 1.6 million by 2040.
Commenting on the positive results, Cedric O’Gorman, chief medical officer of Alpha Cognition, said: “We have successfully demonstrated that ALPHA-1062 is bioequivalent to two different release formulations of galantamine hydrobromide, the immediate release and the extended release. ALPHA-1062, a prodrug of galantamine, was designed to limit gastrointestinal side effects and, if approved, could provide a meaningful advancement for patients with Alzheimer’s Disease.”
