NephroGenex Announces Positive Results For QT Study Of Pyridorin
RALEIGH, N.C.--(BUSINESS WIRE)--NephroGenex, Inc. (Nasdaq:NRX), a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today announced the Company has successfully completed a thorough QT/QTc (TQT) cardiac safety study on Pyridorin. This study assesses a drug’s risk of QT prolongation and its proarrhythmic potential, and is a standard component of all clinical development programs for new molecular entities.
Pyridorin showed no effect on the QT/QTc interval at the expected therapeutic dose of 300 mg and at a higher dose of 1200 mg. In previous Phase 1 and Phase 2 studies, Pyridorin has shown no effect on the QT/QTc interval in patients with diabetic nephropathy.
“These are important study results that support the use of Pyridorin in patients with diabetic nephropathy, many of whom suffer from cardiovascular disease. They are also important given the concerns over cardiac safety seen with other therapies in development for this disease,” said Chief Executive Officer Pierre Legault. “The overall excellent safety profile we are continuing to see, along with the promising efficacy shown in our Phase 2 trials, continues to suggest that Pyridorin has the potential to broadly address the unmet therapeutic needs of the more than 6 million diabetic patients with kidney disease.”
About Diabetic Nephropathy
Diabetic nephropathy is a chronic, degenerative disease of the kidney caused by diabetes. There are approximately 6 million patients with diabetic nephropathy in the United States (approximately 33% of diagnosed diabetics) and this population is expected to grow. Patients suffering from diabetic nephropathy progress to End Stage Renal Failure (and require dialysis) or death. There are currently no adequate treatments for this disease.
About Pyridorin®
Pyridorin inhibits pathogenic oxidative chemistries, which are collectively elevated in diabetic patients and induce pathological changes implicated in the development of diabetic nephropathy. Pyridorin inhibits a broad range of these chemistries which we believe accounts for its effectiveness in slowing the progression of nephropathy in diabetic patients as shown in our Phase 2 studies. Our lead drug candidate was also found to be safe and well tolerated in these same studies.
About NephroGenex, Inc.
NephroGenex (Nasdaq: NRX) is a clinical-stage pharmaceutical company focused on developing therapeutics to treat kidney diseases caused by pathogenic oxidative chemistries. Since our inception, we have collaborated with the leading scientific experts in pathogenic oxidative chemistries to build a strong portfolio of intellectual property and novel acting drug candidates. Our clinical program has been done in collaboration with world leading clinical investigators in kidney disease. Our product pipeline includes an oral formulation of Pyridorin, which is being developed as a chronic, therapeutic agent to slow the progression of diabetic nephropathy, as well as an intravenous formulation of Pyridorin to treat specific types of acute kidney injury.
Cautionary Note on Forward-Looking Statements
This press release contains certain statements that are, or may be deemed "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "expects," "intends," "anticipates," "plans," "believes," "seeks," "estimates," "will," or words of similar meaning and include, but are not limited to, statements regarding the outlook for our future business and financial performance. Forward-looking statements are based on our current expectations and assumptions, which are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Actual outcomes and results may differ materially from those in the forward-looking statements due to global political, economic, business, competitive, market, regulatory and other factors and risks, including the items identified under "Part I—Item 1A—Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2013, filed with the Securities and Exchange Commission ("SEC") on March 31, 2014, as well as in other filings that we may make with the SEC in the future. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we do not undertake and specifically disclaim any obligation to update any forward-looking statements.
Contacts
Investors
The Trout Group
Michael Levitan, 646-378-2920
mlevitan@troutgroup.com
or
Media
BMC Communications
Susan Duffy, 646-513-3119
sduffy@bmccommunications.com
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Pyridorin showed no effect on the QT/QTc interval at the expected therapeutic dose of 300 mg and at a higher dose of 1200 mg. In previous Phase 1 and Phase 2 studies, Pyridorin has shown no effect on the QT/QTc interval in patients with diabetic nephropathy.
“These are important study results that support the use of Pyridorin in patients with diabetic nephropathy, many of whom suffer from cardiovascular disease. They are also important given the concerns over cardiac safety seen with other therapies in development for this disease,” said Chief Executive Officer Pierre Legault. “The overall excellent safety profile we are continuing to see, along with the promising efficacy shown in our Phase 2 trials, continues to suggest that Pyridorin has the potential to broadly address the unmet therapeutic needs of the more than 6 million diabetic patients with kidney disease.”
About Diabetic Nephropathy
Diabetic nephropathy is a chronic, degenerative disease of the kidney caused by diabetes. There are approximately 6 million patients with diabetic nephropathy in the United States (approximately 33% of diagnosed diabetics) and this population is expected to grow. Patients suffering from diabetic nephropathy progress to End Stage Renal Failure (and require dialysis) or death. There are currently no adequate treatments for this disease.
About Pyridorin®
Pyridorin inhibits pathogenic oxidative chemistries, which are collectively elevated in diabetic patients and induce pathological changes implicated in the development of diabetic nephropathy. Pyridorin inhibits a broad range of these chemistries which we believe accounts for its effectiveness in slowing the progression of nephropathy in diabetic patients as shown in our Phase 2 studies. Our lead drug candidate was also found to be safe and well tolerated in these same studies.
About NephroGenex, Inc.
NephroGenex (Nasdaq: NRX) is a clinical-stage pharmaceutical company focused on developing therapeutics to treat kidney diseases caused by pathogenic oxidative chemistries. Since our inception, we have collaborated with the leading scientific experts in pathogenic oxidative chemistries to build a strong portfolio of intellectual property and novel acting drug candidates. Our clinical program has been done in collaboration with world leading clinical investigators in kidney disease. Our product pipeline includes an oral formulation of Pyridorin, which is being developed as a chronic, therapeutic agent to slow the progression of diabetic nephropathy, as well as an intravenous formulation of Pyridorin to treat specific types of acute kidney injury.
Cautionary Note on Forward-Looking Statements
This press release contains certain statements that are, or may be deemed "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "expects," "intends," "anticipates," "plans," "believes," "seeks," "estimates," "will," or words of similar meaning and include, but are not limited to, statements regarding the outlook for our future business and financial performance. Forward-looking statements are based on our current expectations and assumptions, which are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Actual outcomes and results may differ materially from those in the forward-looking statements due to global political, economic, business, competitive, market, regulatory and other factors and risks, including the items identified under "Part I—Item 1A—Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2013, filed with the Securities and Exchange Commission ("SEC") on March 31, 2014, as well as in other filings that we may make with the SEC in the future. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we do not undertake and specifically disclaim any obligation to update any forward-looking statements.
Contacts
Investors
The Trout Group
Michael Levitan, 646-378-2920
mlevitan@troutgroup.com
or
Media
BMC Communications
Susan Duffy, 646-513-3119
sduffy@bmccommunications.com
Help employers find you! Check out all the jobs and post your resume.