ProGo® is free from the gastrointestinal effects seen with iron supplementation such as nausea, vomiting, constipation, and a metallic taste
Hofseth BioCare (HBC) submitted a notification to the Food and Drug Administration (FDA) 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: “supports healthy ferritin and haemoglobin levels”, “helps maintain iron-rich blood”, “promotes energy utilisation”, “supports red blood cell production”, “supports gastrointestinal and immune system health” and “assists in iron absorption from your daily diet”.
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 haemoglobin. As such, ProGo® is free from the gastrointestinal (GI) effects seen with iron supplementation such as nausea, vomiting, constipation, and a metallic taste.
“Our vision is to utilise all off-cuts from the fish farming industry to help develop tomorrow’s diet and medicine, and now we are succeeding. Our research and procedures are strong,” says Roger Hofseth, CEO, Hofseth BioCare.
The US 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 anaemia. Trial 2, a smaller, supporting study for safety, was conducted in 14 healthy adults with normal blood counts, ie nonanemic subjects. Both trials used whey protein isolate (WPI) as the comparator / placebo. Unlike ProGo®, WPI did not have a significant impact on ferritin or haemoglobin in either study.
It is anticipated that HBC’s work to identify the peptide fraction driving the positive effect on ferritin and haemoglobin 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.
“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 crystallise,” says Crawford Currie, Medical R&D, Hofseth BioCare.