XORTX Shares Findings of Diabetes Study in Youths Supporting High Uric Acid Advances Kidney Disease Progression

Download as PDF

Study Provides Further Support Expanding XrX-008 Potential Market

CALGARY, Alberta, April 16, 2019 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (CSE: XRX; OTCQB: XRTXF), a biopharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, congratulates the TODAY study team and Dr. Petter Bjornstad on successful completion of their study and findings in youths with Type 2 Diabetes (“T2D”).  The findings show for the first time that high uric acid levels are common in young patients with T2D nephropathy (“T2DN”) and that high serum uric acid levels (“SUA”) are an independent risk factor for progression of kidney disease in this newly described and vulnerable group. In addition, the effects of SUA as an independent risk factor on high blood pressure and protein excretion (albuminuria/ proteinuria) into the urine are also described1.

Dr. Allen Davidoff, CEO of XORTX, stated, “The results of the TODAY study align with other recent studies that show that SUA is increasingly recognized as a serious risk factor for high blood pressure in T1D, T2D and in the general population.  This work identifies, for the first time, a growing population of young individuals with T2D, ~25% of whom are at risk for a concerning combination of high blood pressure and increased albumin excretion indicating the onset of kidney disease.  Importantly, the presence of increased uric acid levels, despite pre-existing metformin treatment for their diabetes, is an independent risk factor for aggressively progressing kidney disease. This seven-year, longitudinal study has successfully demonstrated a relationship between SUA, increased risk of high blood pressure and increased risk of urinary albumin excretion in young, T2D patients.” 

Historically, SUA levels have been measured only as a secondary confirmation of the cause of a gout attack. For this reason, data on the association of circulating uric acid levels and their association to metabolic, cardiovascular (CVD) or kidney disease progression is sparse. This study shows for the first time that SUA levels above normal may be driving kidney disease progression early in the disease process that leads proteinuria in young adults with T2DN.  The importance of this study in T2DN youth is that DN and cardiovascular disease are leading causes of morbidity and mortality in type 2 diabetes, and develop at an alarming rate in adolescents with T2DN2-4, increased uric acid concentrations in serum are an independent risk factor for this disease process.

The incidence of T2D is increasing worldwide. At present, there are few therapeutic options to treat progressive kidney disease in the nearly 10 million individuals with diabetic nephropathy in the United States and greater than 100 million people worldwide5.  Current projections suggest that in the next 15 years the population of individuals with diabetes will grow from ~350 million today to nearly 550 million by 2035.  T2D is increasingly diagnosed in youth and now accounts for 20% to 50% of new-onset diabetes case patients6. By deduction, the population of individuals with T2DN is expected to rise proportionately to ~175 million individuals in the next 15 years, many of whom will be youths or young adults.

T2DN is a common complication of diabetes and the leading cause of chronic kidney disease in the developed world. Approximately 40% of persons with diabetes develop T2DN, manifested as albuminuria and/or decreased glomerular filtration rate. Even mild degrees of albuminuria and decrease in glomerular filtration rate are associated with significantly increased risks of cardiovascular disease, end-stage renal disease, and premature deaths7.

Dr. Bjornstad is a clinical researcher and an assistant professor of pediatrics and medicine in the department of pediatrics, division of endocrinology and department of medicine, division of nephrology at the University of Colorado School of Medicine. He is a NIH and JDRF funded translational researcher with a track record of research potential and success. Dr. Bjornstad is a key opinion leader and researcher on the importance of T2DN and enhanced need for therapeutic options in aggressively advancing forms of DN. The TODAY study, published April 7, 2019, furthers the concept that when left untreated uric acid levels in youths with T2DN are a serious risk factor toward rapid progression of kidney disease.

References:

  1. Bjornstad, P, et. al., Elevated Serum Uric Acid Is Associated with Greater Risk for Hypertension and Diabetic Kidney Disease in Obese Adolescents with Type 2 Diabetes, Diabetes Care, April 2019.
  2. Dabelea D., et. al., SEARCH for Diabetes in Youth Research Group. Association of type 1 diabetes vs type 2 diabetes diagnosed during childhood and adolescence with complication during teenage years and young adulthood, JAMA 2017;317:825-835.
  3. TODAY Study Group. Rapid rise in hypertension and nephropathy in youth with type 2 diabetes: the TODAY clinical trial, Diabetes Care 2013;36:1735-1741.
  4. Al-Saaed A.H., et. al., An inverse relationship between age of type 2 diabetes onset and complication risk and mortality: the impact of youth-onset type 2 diabetes. Diabetes Care 2016;39:823-829
  5. Gheith O, et. al., Diabetic Kidney Disease: worldwide difference of prevalence and risk factors, J Nephropharmacol, 5(1):49-56, 2016
  6. Chen J, et. al., Diabetic Nephropathy: Scope of the Problem, Diabetes and Kidney Disease, April 2014, pp9-14
  7. Whiting D, Guariguata L, Weil C, et al. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011;94:311–21.
  8. Bobo  N, Evert  A, Gallivan  J,  et al; Diabetes in Children Adolescents Work Group of the National Diabetes Education Program.  An update on type 2 diabetes in youth from the National Diabetes Education Program.  Pediatrics. 2004;114(1):259-263.

About XORTX Therapeutics Inc.

XORTX Therapeutics Inc. is a biopharmaceutical company focused on developing innovative therapies to treat progressive kidney disease.  XORTX has lead programs to develop treatments for progressive kidney disease due to diabetes, diabetic nephropathy and polycystic kidney disease.  Secondary programs focus on developing therapies for health consequences that accompany pre-diabetes, diabetes and cardiovascular disease. Additional information on XORTX Therapeutics is available at www.xortx.com.

For further information, please contact:

Allen Davidoff, CEO
adavidoff@xortx.com or +1 403 455 7727

or Erik Matthews, Corporate Communications & Investor Relations
erik@xortx.com or +1 747 203 5240

The CSE has neither approved nor disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

This news release includes forward looking statements that are subject to assumptions, risks and uncertainties. Statements in this news release which are not purely historical are forward looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs and expectations will prove to be accurate. The Company cautions readers that all forward looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward looking statements. Readers are advised to rely on their own evaluation of such risks and uncertainties and should not place undue reliance on forward looking statements. Any forward looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward looking statements, or to update the reasons why actual events or results could or do differ from those projected in the forward looking statements. The Company assumes no obligations to update any forward looking statements, whether as a result of new information, future events or otherwise.

XORTX_Therapeutics_Inc.jpg

Source: XORTX Therapeutics Inc.

Released April 16, 2019