Captozyme Initiates Clinical Study of Nephure Oxalate-Reducing Enzyme

Captozyme, Inc. announced today that it is initiating a prospective
double-blind, randomized, placebo controlled, cross-over study, with
Nephure™, an oxalate reducing enzyme, to determine the extent to which
Nephure vs. placebo reduces urinary oxalate excretion (mg/24 hour) in
healthy subjects who are provided a controlled diet.

“Staying true to the science is what we are built on as a company, so we
are proud to be taking this important step in further demonstrating how
Nephure assists those on a low oxalate diet,” said Helena Cowley, CEO of
Captozyme. “With this high-quality study, we aspire to deliver a grade
of evidence data that will further strengthen the confidence in our
enzymes. With Nephure, it is about giving people freedom back in their
foods choices. One less thing to think about for those who avoid
oxalates.”

The key ingredient in Nephure was developed as a food ingredient to
reduce both soluble and insoluble oxalate from a variety of foods and
beverages.1 Nephure has the ability to degrade oxalate in
food over a wide pH range, including the acidic pH of the stomach. The
Nephure oxalate-reducing enzyme has been affirmed to be “generally
recognized as safe” (GRAS) by an independent panel of experts through
scientific procedures following stringent U.S. Food and Drug
Administration (FDA) safety criteria.

Limiting oxalate-rich foods and sodium intake (recommended in the AUA
Guidelines on the dietary management of calcium-oxalate kidney stones)
is difficult because oxalate is present in many different foods, and the
levels in each food vary considerably.2 In addition, the
content of oxalate is particularly high in healthy plant foods,
including vegetables, cereal grains, nuts, beans, and foods and
beverages originating from the same. In contrast, a low-sodium diet has
been successfully incorporated by many because excess sodium removal
from packaged foods is more readily available to the public.

Kidney stones are the most common result of hyperoxaluria (excessive
urinary excretion of oxalate).3 The majority of kidney stones
form in healthy individuals without systemic or inherited diseases
(idiopathic). Frequent development of kidney stones may lead to chronic
kidney disease, hypertension, and ultimately to end-stage renal disease.3 Epidemiological
studies have indicated that approximately 80% of patients who develop
kidney stones form calcium stones, mostly from calcium oxalate and less
often from calcium phosphate.4 Recent guidelines for the
prevention and management of kidney stones3,5 have reported
that few promising pharmaceutical therapies have emerged over the last
decade. Dietary modifications including a low-oxalate and low-sodium
diet coupled with adequate fluid intake, are recommended and considered
successful for the prevention of hyperoxaluria and kidney stone
recurrence.3,5

“Per the AUA Guidelines, patients who suffer from calcium oxalate kidney
stones are often recommended to make dietary lifestyle changes,
including a low-oxalate diet. This diet can be extremely restrictive to
the foods patients can enjoy, as it reduces the amount of daily oxalate
intake to 50 mg/day,” said Dr. Victoria Bird, urologist and director at
National Medical Association and Research Group. “The results of this
clinical study will be welcome news to our health community; it would
help our patients comply with the low-oxalate diet, while also giving
them some flexibility to enjoy the foods they’ve missed in moderation.”

Nephure
has been commercially available, through Entring, LLC, a subsidiary of
Captozyme, Inc. since end of 2017. For more information on Nephure,
visit www.Nephure.com.
Connect with Nephure on Facebook
and Twitter.

About Captozyme, Inc.

Captozyme,
Inc. is a biotechnology company developing enzymes and formulations
to advance knowledge in the area of gut health and through its products
advance the health and wellness of people. Captozyme, Inc. also houses a
cGMP manufacturing facility for production of Phase 1 clinical trial
drug substance with a focus on live biologics development. The company
is based in Gainesville, Florida. Learn more about Captozyme by visiting www.captozyme.com.

About Entring, LLC

Entring, LLC specializes in enzyme-based products that provide
consumer-friendly choices for people with nutritional limitations. As a
subsidiary of the research and development organization, Captozyme,
Inc., Entring’s products are backed by more than 60 years of combined
experience in biochemical engineering, including extensive research on
innovative approaches for kidney health. Launched in 2017, Entring’s Nephure
is the first-to-market enzyme product offering flexibility to people
with oxalate-related nutritional limitations.

References:

1. Cowley H, Yan Q, Koetzner L, Dolan L, Nordwald E, Cowley AB. In vitro
and in vivo safety evaluation of Nephure™. Regul Toxicol Pharmacol
2017;86:241-252.

2. Holmes RP, Kennedy M. Estimation of the oxalate content of foods and
daily oxalate intake. Kidney Int 2000;57:1662-1667.

3. Xu H, Zisman AL, Coe FL, Worchester EM. Kidney stones: an update on
current pharmacological management and future directions. Expert Opin
Pharmacother 2013;14:435-447.

4. Johnson CM, Wilson DM. O’Fallon WM, Malek RS, Kurland LT. Renal stone
epidemiology: a 25-year study in Rochester, Minnesota. Kidney Int
1979;16:624-631.

5. Pearle MS, Goldfarb DS, Assimos DG, Curhan G, Denu-Ciocca CJ, Matlaga
BR, Monga M, Penniston KL, Preminger GM, Turk TM, White JR, American
Urological Association. J Urol 2014;192:316-324.

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