Hofseth BioCare ASA is yet again part of an Exclusive Short-List of Companies to Have Successfully Notified FDA while receiving a No Objection Letter for ProGo® Bioactive Peptides.
Summary Highlights of the FDA’s NDI Process for HBC and what it means:
- The FDA’s NDI notification process is the only pre-market gate for demonstrating identity, safety, and even cGMP quality for both dietary supplements and/or dietary ingredients contained in dietary supplements that are new to the US marketplace.
- The NDI letter for ProGo® is the highest safety rating and attestation the company could have received from the FDA. This achievement follows on the heels of successful receipt of the same accolades for both CalGo® and OmeGo® late last year. Today, HBC’s entire portfolio of human food-grade ingredients has received FDA’s No Objection Letter, also called an “Acknowledgement Without Comment” Letter or Acknowledgement (AKL) Letter.
- The historical acknowledgment rate of NDI notifications by the FDA is low (approximately 30%), prompting food companies to choose the easier self-GRAS conclusion pathway.
- After rigorous review by FDA scientists (NDI Review Team), ProGo® is permitted to deliver up to 24 grams/day in adults (excluding pregnant women), significantly in excess of the maximum daily dose used on all the clinical trials.
“As a valued client of KGK, HBC has a novel and innovative technology for extracting nutritional components from Atlantic salmon in a very sustainable way. The FDA again evaluated that innovative process and the composition of ProGo® and, in return, has offered the highest safety rating possible. This acknowledgement AKL letter from FDA speaks to the quality and safety of HBC’s ProGo®,” said Najla Guthrie, President & Chief Executive Officer of KGK. “These FDA no-objection letters also help HBC in the global market as many countries outside of the US are looking for attestation that the FDA has reviewed nutritional supplements for safety. HBC has navigated that regulatory hurdle and can check that box,” added Ms. Guthrie.
“ProGo® is permitted to deliver up to 24 grams a day in adults. The FDA’s NDI process is the highest benchmark of safety that a manufacturer or distributor of supplements can achieve in the US market. HBC has just distinguished itself from its competitors, and they demonstrate their commitment to ensuring consumer confidence with US retailers by navigating FDA’s difficult NDI process. KGK has significant experience in helping its clients achieve their goals by earning these high marks of achievement and market distinction,” said Dr. Corey Hilmas, Chief Regulatory Officer of KGK. “Consumers and retailers are starting to understand what it means to have an NDI no-objection letter from the FDA. Both can have confidence that the serving levels in these products are correctly chosen, based upon appropriate scientific methods and rigorously reviewed by FDA,” added Dr. Hilmas.
ABOUT HOFSETH BIOCARE
HBC is a Norwegian consumer and pet health ingredient supplier and an incubator for new drug leads. For new drug leads, research is ongoing to identify the individual compounds within HBC's ingredients that modulate inflammation and the immune response to support and enhance health. Pre-clinical studies are ongoing both internally in HBCs labs and externally through a number of academic collaborations. Lead pharmaceutical candidates include an oral analogue to treat inflammatory disease driven by eosinophils (such as eosinophilic asthma and eosinophilic esophagitis), and peptides targeting iron metabolism through FTH1, with prostate cancer one lead indication. For the core nutraceutical business, clinical trial work with the oil is ongoing to assess its benefit in immune health and supporting healthy ageing. Clinical trials are also ongoing to assess our natural collagen-calcium complex in bone and joint health and we plan to start a clinical trial targeting our ProGo peptides as a medical food for GI health. This project is led by our collaborator partners at Stanford University with clinical trial work expected to begin during this year.
The company is founded on the core values of sustainability, optimal utilization of natural resources and full traceability. 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, Palo Alto and Tokyo. Hofseth BioCare's headquarters are in Ålesund, Norway with branches in Oslo, London, Zürich, Chicago, Palo Alto and Tokyo.
ABOUT KGK SCIENCE
Founded in 1997, KGK Science Inc., a subsidiary of Wellbeing Digital Sciences (NEO: MEDI) (OTC: KONEF) (FRA: SQ2), is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on the nutraceutical, cannabis and emerging psychedelic industries. The business has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. On an approximate basis, the business to date has produced 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database and collected 10 million data points. For additional information, please visit kgkscience.com.
For further information, please contact:
Wellbeing Digital Sciences & KGK Science Inc.
Natalie Dolphin
VP of Marketing & Investment Relations
Email: ndolphin@wellbeingdigital.co
Twitter: @Wellbeing_IR
Dr. Crawford Currie,
Head of Medical R&D at Hofseth BioCare ASA
Tel: +44 7968 195 497
E-mail: cc@hofsethbiocare.no
This information is subject to the disclosure requirements pursuant to Section 5-12 of the Norwegian Securities Trading Act
