Sidero Bioscience Awarded Grant to Support Clinical Trial of BioFe Medical Food for the Management of Iron Deficiency

HERSHEY, Pa.–(BUSINESS WIRE)–Sidero
Bioscience, a specialty biotechnology company advancing disruptive
technologies targeting human digestive health, has been awarded a grant
by the National Institute of Diabetes and Digestive and Kidney Diseases,
part of the US National Institutes of Health (NIH). The $225,000 Phase I
STTR grant, in collaboration with the Pennsylvania State University,
will support a clinical trial of BioFe in people with iron deficiency.

“We are delighted to be selected by the NIH to support the clinical
development goals for our first product candidate, BioFe^TM
medical food for the management of iron deficiency,” says Darren Wolfe,
President & CEO of Sidero. “Securing this new dedicated funding source
allows Sidero to advance human clinical testing and accelerate BioFe
development.”

The NIH commented on BioFe, stating, “The committee appreciated the
profound potential impact of the proposed work, considered
‘game-changing’, on the treatment of anemia in children.”

The World Health Organization claims, “Iron deficiency is the most
common and widespread nutritional disorder in the world. The numbers are
staggering: 2 billion people – over 30% of the world’s population…”.
The most common symptom of iron deficiency is Iron Deficiency Anemia
(IDA). IDA impedes motor and mental development in children leading to
lifelong cognitive deficiencies and causes fatigue, reduced work
capacity, and reduced quality of life in adults. Iron deficiency without
anemia is also linked to restless leg syndrome (RLS), hearing deficits,
reduced athletic performance, and heart failure morbidity among others.

While oral iron supplements can be both effective and inexpensive, they
suffer from substantial gastrointestinal side effects reducing
compliance by up to 50%. Alternatively, intravenous iron can also be
effective for iron supplementation but requires frequent transfusions
and is expensive leading to both patient and payor dissatisfaction. The
market for IV-Iron alone is expected to reach $1.8 Billion by 2020.

James Connor, Chairman of the Board of Sidero and co-inventor of the
Siderosorb^TM Medical Food technology platform, states, “The
dedicated mission of Sidero is to provide a safe, effective, and
economical remedy for iron deficiency for all peoples of the world.”

Sidero is advancing the patented Siderosorb^TM Medical Food
technology platform utilizing nutritional Baker’s yeast, Saccharomyces
cerevisiae, to provide therapeutic proteins/complexes as food for
consumption to improve human health. Medical foods have a simplified and
streamlined regulatory pathway allowing rapid and low-cost development,
significantly accelerating market access. BioFe is nutritional yeast
expressing high levels of the Ferritin protein, FTH1, that is a natural
iron transport and storage protein normally produced at low levels by
almost all living organisms. An illustrative example of the natural
biology of the Ferritin/Iron complex is its presence in human breast
milk, providing nursing infants the readily adsorbed iron required for
rapid learning and development without gastrointestinal upset.

Visit www.SideroBio.com
for additional information.

Contacts

Sidero Bioscience, LLC
Darren Wolfe, PhD
President & CEO
412-352-2498
DWolfe@SideroBio.com