Bioactive Peptides™ are in the unique position of being the first and only non-iron containing product in the US market to maintain healthy levels of ferritin and hemoglobin.
Hofseth BioCare submitted a notification to the Food and Drug Administration (FDA) in the US for the use of six structure function claims for ProGo®’s Bioactive Peptides™.
The FDA did not oppose the use of our claims during the notice period and the claims on the US label are:
It is anticipated that HBC will now look to collaborate with global formulators and contract manufacturers to establish a major presence in the nutraceutical market with a portfolio of offerings with the aforementioned claims.
A better alternative for millions
As such, ProGo® is free from the gastrointestinal (GI) effects seen with iron supplementation such as nausea, vomiting, constipation, and a metallic taste. Unsurprisingly, these GI effects can result in poor compliance and variable treatment outcomes with iron supplements.
“Our product will be a better alternative for millions of people who struggle with negative side effects or poor effect of traditional iron supplementation. For Hofseth BioCare, we see vast market opportunities crystalize,” says Crawford Currie, Medical R&D, in Hofseth BioCare.
It is anticipated that HBC’s work to identify the peptide fraction driving the positive effect on ferritin and hemoglobin will be completed by Q1 2021. This will enable encapsulation of the peptide fraction and the commencement of the next stage of clinical development of the bioactive peptides.
Important new option for iron supplement
Currently dietary modification or iron supplementation, either via tablets or injection, are the only ways available to increase iron levels or absorption. Dietary modification is often impractical for social, economic or cultural reasons and iron supplementation frequently causes gastrointestinal side effects. Iron supplementation also carries the risk of toxicity from iron overload. As such, HBC believes that ProGo® now provides an important new non-iron containing option for the maintenance of healthy levels of ferritin and hemoglobin.
Bioactive Peptides™ are very well tolerated and have no GI side effects, rather they support GI health.
Based on two studies
The U.S. structure function claims are based on two studies of ProGo® in adults (18 years and older). Trial 1 was conducted in 48 otherwise healthy adults with iron deficiency anemia. Trial 2, a smaller, supporting study for safety, was conducted in 14 healthy adults with normal blood counts, i.e. non-anemic subjects. Both trials used whey protein isolate (WPI) as the comparator / placebo. Unlike ProGo®, WPI did not have a significant impact on ferritin or hemoglobin in either study.