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 hemoglobin 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 hemoglobin. 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.

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.

“Our vision is to utilize 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. Hofseth BioCare is a unique example of how long-term investment results in world leading technology which enables the upcycling of waste into a valuable resource. We help the fish farming industry improve its sustainability, and at the same time we contribute to improving people’s lives through better health,” says Roger Hofseth, CEO of Hofseth BioCare.

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.

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™.

 “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.

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.

About ProGo®

ProGo® is produced via HBC’s patented enzymatic hydrolysis of salmon offcuts (left-over “waste” of the fish after filleting). The resulting peptides and amino acids are more easily handled by the body with a resulting 98% bioavailability (absorption). Beyond nutrition, the peptides have shown significant bioactivity and aiding the maintenance of healthy blood counts. Ongoing trial work continues to further assess the health benefits of ProGo® and to identify the bioactive peptides driving the beneficial effects.

For further information, please contact:

James Berger, Head of Investor Relations & Strategy of Hofseth BioCare ASA
Phone: +41 79 950 1034
E-mail: jb@hofsethbiocare.no

Dr. Crawford Currie, Medical R&D at Hofseth BioCare ASA
Phone: +44 7968 195497
E-mail: cc@hofsethbiocare.no

About Hofseth BioCare ASA:

HBC is a Norwegian biotech company that develops high-value ingredients and finished products. Ingredients are further developed into discovery and pre-clinical studies in multiple clinics and university research labs in several countries. Additional lead clinical and pre-clinical candidates are in development towards a Gastro-Intestinal (GI) Protective Medical Food, Medical Food to help treat age-related Sarcopenia, and future phase 1 studies on treatment of Anemia and NEC-IBS with Salmon Protein Hydrolysate fractions.

The company is founded on the core values of sustainability, traceability and optimal utilization of natural resources. Through an innovative hydrolysis technology, HBC can preserve the quality of lipids, proteins and calcium from fresh salmon off-cuts. Hofseth BioCare's headquarters are in Ålesund, Norway with branches in Oslo, London, Zürich, Chicago, Mumbai, Palo Alto and Tokyo.

HBC is listed on Oslo Stock Exchange Axess list with ticker "HBC". More information about Hofseth BioCare at hofsethbiocare.com and facebook.com/hofsethbiocare

This information is subject to the disclosure requirements pursuant to Section 5-12 of the Norwegian Securities Trading Act