ReGen Therapeutics, a UK firm focused on creating drugs for Alzheimer's disease, gained the rights to the polypeptide product Colostrinin in the late 1980s from a Polish research institute.
It initially sought to develop the compound as a pharmaceutical but over the last two years has changed its focus to the nutraceutical market and is now in discussions with partners to market Colostrinin for the 'maintenance of healthy mental function'.
The supplement could be available in North America by next year, according to ReGen chairman and chief executive Percy Lomax.
A double-blind, placebo-controlled trial on 106 people with mild to moderate Alzheimer's disease, published last year, found that after 15 weeks of taking the product in tablet form, around 40 per cent of the patients were stabilised or had an improved overall response in tests on cognitive function.
The greatest effects were seen in earlier stages of the disease and no serious adverse events were observed during the trial.
The new research, published online in the peer-reviewed journal Neuropeptides on 9 May, reveals a possible mechanism for this effect. Colostrinin appears to prevent the aggregation of beta-amyloid peptide Abeta (1-40) in vitro, dissolving the dense fibres that form in the brain over time.
Dr Marian Kruzel, the company's chief scientific consultant and a co-author of the publication, said: "There is consensus in the scientific community that the production and accumulation of beta amyloid aggregates is central to the pathogenesis of Alzheimer's disease. We believe that this data provides the molecular basis for explaining the beneficial effect of Colostrinin in patients with mild and moderate Alzheimer's disease, which was reported by ReGen last year."
She added that the study confirms preliminary findings reported at the Alzheimer's Europe conference in Prague last May. They showed that Colostrinin even at very low concentrations can protect nerve cells from the toxic effect of beta amyloid fibrils.
The company is doing further research to clarify the biochemical basis of this action.
Alzheimer's disease is a progressive, neurodegenerative and ultimately fatal disease that slowly destroys the brain. At an advanced stage, Alzheimer's disease sufferers lose the ability to take care of themselves and must be looked after either by family or in residential care homes and hospitals.
A recent conference on Alzheimer's in the US heard that worldwide direct costs of caring for those with the disease and other forms of dementia amount to $156 billion, based on a worldwide prevalence estimate of 27.7 million people with dementia.
With the current trend in demographics, this figure will rise to 34 million by 2025, presenting clear opportunities for supplements targeted at prevention.
Lomax told NutraIngredients.com that the firm was already in advanced discussions with a nutraceutical company active in the US, Canada and Mexico.
"Our most advanced discussions are in the US but we are also talking to marketing partners in Europe, Japan and Oceania," he said, adding that a Colostrinin supplement could be on the North American market next year.
While there will be direct competition in the anti-ageing and cognition market, he believes that "there is nothing directly comparable in the way it works".
The product, thought to contain the fractions of three different proteins, and 81 amino acids extracted from bovine colostrum, is made through a complex manufacturing process, currently being scaled up at Sterling Technology, a leading provider of colostrum products for the US nutraceutical market based in South Dakota.
ReGen says it should have sufficient material available to begin safety studies in the next few months.