Hofseth BioCare addresses anemia without iron in US ProGo launch

14 Oct 2020 --- Hofseth BioCare (HBC) is launching ProGo’s Bioactive Peptides in the US to address healthy iron levels. According to the company, Bioactive Peptides are the first and only product without iron in the US market to maintain healthy ferritin and hemoglobin levels.

“This will be a unique label,” Crawford Currie, medical R&D at Hofseth BioCare, tells NutritionInsight.

Instead of containing iron, ProGo causes a positive interaction with the body resulting in an increase in ferritin, which drives the correction of iron deficiency anemia (IDA), he explains.

Dietary modification to address IDA is often impractical for social, economic or cultural reasons. Meanwhile, iron supplementation carries the risk of toxicity from iron overdose and is often associated with gastrointestinal side effects. 

“Iron tablets need to be taken two to three times a day for three to six months and cause troublesome side effects such as constipation, nausea and a metallic taste in the mouth,” details Currie. 

As a result, the focus for IDA has historically been on producing different formulations of iron – including injectable forms – to try and improve tolerability.

However, HBC’s solution bypasses the difficulties surrounding iron and offers a well-tolerated product that supports gastrointestinal health. 

ProGo is produced via HBC’s patented enzymatic hydrolysis of salmon offcuts. The resulting peptides and amino acids are easily handled by the body, with a resulting 98 percent bioavailability. The product can also help reduce Body Mass Index.

Claims for the US
US labels for ProGo’s Bioactive Peptides will be able to make six structure function claims. The Food and Drug Administration (FDA) did not oppose the use of HBC’s claims within the notice period. The product can say:

• Supports healthy ferritin and hemoglobin levels. 
• Helps maintain iron-rich blood.
• Promotes energy utilization.
• Supports red blood cell production.
• Supports gastrointestinal and immune system health.
• Assists in iron absorption from your daily diet.

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.

The claims are based on two GoPro studies in adults. 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.

Both trials used whey protein isolate (WPI) as the placebo. Unlike ProGo, WPI did not have a significant impact on ferritin or hemoglobin in either study.

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.

The company is currently also pursuing qualified health claims from Health Canada for ProGo’s use for IDA.ProGo’s Bioactive Peptides bypasses the difficulties surrounding iron supplements. 

Working backward from the ingredient
A group of peptides within ProGo upregulate the expression of the FTH1 gene system, which plays a role in encoding ferritin. 

“When we saw the upregulation of FTH1 expression in human gut cells in the lab, we knew we should investigate the potential of the peptides for the correction of IDA,” Currie explains.

“Many companies decide on a condition to try and target and then look to design a drug to hopefully hit the appropriate target in the body to help improve things. Alternatively, they may look for a potential drug candidate among their drug library,” says Currie.

In contrast, HBC has taken an entirely different approach. The company takes the ingredient it already has – the peptides in this case – and assesses what effects it has in the lab. It then focuses its research efforts accordingly. 

Other potential uses for ProGo include anti-inflammation in the gut. “There is a range of other effects that we are assessing in the lab at the moment, including helping sarcopenia and the prevention of diabetes,” Currie concludes. 

By Katherine Durrell