Hofseth Biocare ASA: HBC'S PROGO BIOACTIVE PEPTIDES NOW IS A 'NEW DIETARY INGREDIENT' (NDI) FOR THE US FDA

Hofseth Biocare ASA: HBC'S PROGO BIOACTIVE PEPTIDES NOW IS A "NEW DIETARY INGREDIENT" (NDI) FOR THE US FDA

29 Aug 2022 08:44 CEST

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
(https://www.kgkscience.com/).

For further information, please contact:

Wellbeing Digital Sciences & KGK Science Inc.
Natalie Dolphin
VP of Marketing & Investment Relations
Email: [email protected]
Twitter: @Wellbeing_IR

Dr. Crawford Currie,
Head of Medical R&D at Hofseth BioCare ASA
Tel: +44 7968 195 497
E-mail: [email protected]

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

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Source

Hofseth BioCare ASA

Provider

Oslo Børs Newspoint