Study will evaluate Nephure vs. placebo in the reduction of urinary oxalate associated with food
GAINESVILLE, Fla.--(BUSINESS WIRE)-- 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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Source: Captozyme, Inc.
