SHAWNEE, Kan. - Jan. 11, 2016 - PRLog -- Novadiol, Inc., a Kansas City-based biopharmaceutical company developing first-in-class treatments for secondary hyperparathyroidism (SHPT) and hypovitaminosis D, announced the submission of an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) on December 24, 2015. Novadiol’s IND, known as NVCKD-001, will treat secondary hyperparathyroidism in stage 3 and stage 4 chronic kidney disease (CKD) patients. Novadiol has the worldwide rights to the patented, once-a-week administration of this molecule.
Novadiol’s CEO, G.P. Georges, was excited about the opportunity to move forward down the regulatory path with NVCKD-001. “Completing this key milestone in our short regulatory path is very encouraging,” said Georges. “To think that we will be able to positively affect the lives of so many CKD patients will be a rewarding experience for our team.”
In the U.S., according to the National Kidney Foundation and the Centers for Disease Control and Prevention (CDC), over 20 million patients suffer from CKD. More than 4 million of these patients have stage 3 or 4 CKD and suffer from SHPT. Novadiol’s only potential competition in this market will be OPKO’s late stage product Rayaldee, which successfully completed clinicals and currently is under review by the FDA. Rayaldee is a once-a-day dosage of the same molecule as NVCKD-001 aimed at the same population and indication. “We applaud OPKO for moving forward with a daily dose (Rayaldee), for this treatment is much needed by the stages 3 and 4 CKD patients,” said Georges. “We believe that our once-a-week therapy will offer more convenience and improved compliance to this patient population, which is burdened by multiple medications. Additionally, it is likely to be preferred by payers and providers. Once NVCKD-001 is approved, CKD stages 3 and 4 patients will have a choice to take a daily or a weekly dose to treat their SHPT,” added Georges. Novadiol plans to start a Phase 1 clinical trial by March of 2016.
Novadiol, Inc. (www.novadiol.com) is located in Shawnee, Kansas, a suburb of Kansas City. Georges is a successful entrepreneur who started Nephro-Tech Inc., a renal vitamin company, in the early 1990s.
Questions concerning this press release may be e-mailed to Novadiol, Inc. at bd@novadiol.com.
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