MINNEAPOLIS, April 30, 2019 (GLOBE NEWSWIRE) -- DiaMedica Therapeutics Inc. (DMAC), a clinical-stage biotechnology company, today announced that Dr Harry Alcorn, its Chief Medical Officer will be presenting “CKD New Therapeutic Development: DM199 for Chronic Kidney Disease” at the Chronic Kidney Disease Drug Development (“CKD3”) summit in Boston on Tuesday May 7, 2019, at 1:30 Eastern Time.
CKD3 is a uniquely focused conference that unites key opinion leaders to identify and discuss critical factors in determining the success of current chronic kidney disease (“CKD”) pipelines and evaluate new treatments that have the potential to significantly impact the standard of care for this serious unmet medical need. Leading experts from innovative biotechnology and pharmaceutical companies, academia and key service providers come together at the CKD3 summit to present comprehensive insight into the cutting-edge progress of CKD drug development research. This year’s summit is being held at the Revere Hotel Boston, 200 Stuart Street, Boston.
Chronic Kidney Disease
The National Kidney Foundation estimates that 30 million people in the United States suffer from CKD a debilitating and potentially life-threatening condition that can dramatically diminish patient quality of life and generates significant economic burden throughout the world. Diabetes mellites (Type I and Type II) and hypertension are the primary causes of CKD. Several other health conditions can also damage your kidneys and lead to CKD and potentially end stage renal disease including lupus nephritis, polycystic kidney disease, interstitial nephritis, glomerulonephritis, acute kidney injury and focal segmental glomerulosclerosis.
CKD is characterized by a progressive decline in overall kidney function as measured by glomerular filtration rate (“GFR”) (a test used to check how well the kidneys are filtering excess fluid and waste products out of blood), and albuminuria (the amount of albumin protein excreted in your urine). When GFR gets too low, patients develop end stage renal disease (“ESRD”) and require dialysis or a kidney transplant to survive. CKD often begins with an increase in blood glucose, which leads to the thickening of the glomerular membrane, known as fibrosis. As kidney function becomes impaired, GFR decreases and abnormal amounts of protein are released into the urine through damaged capillary pores of the kidney. Additionally, increased blood glucose leads to increased blood pressure, reactive oxygen species, advanced glycation end product formation (harmful compounds that are formed when protein or fat combine with sugar in the bloodstream) and inflammation.
Currently, there is no cure for CKD and treatment involves management of the symptoms of disease. Blood pressure medications, such as angiotensin converting enzyme inhibitors (“ACEi”) or angiotensin receptor blockers (“ARB”), are often prescribed to control hypertension, and hopefully, slow the progression of CKD. However, side effects associated with ACEi medications may include hyperkalemia, cough and angioedema which often prevents optimal dosing or leads to complete discontinuation of treatment for these patients.
DM199 for Chronic Kidney Disease
DiaMedica’s product candidate, DM199, a recombinant (synthetic) form of the KLK1 protein, offers a potentially novel approach for the treatment of CKD since the KLK1 protein plays a vital role in normal kidney function. Studies suggest that patients with moderate to severe CKD may excrete abnormally low levels of KLK1 in their urine indicating a deficiency in their ability to naturally produce KLK1. DiaMedica believes that administering DM199 may replenish KLK1 levels, restore the body’s natural systems and prevent or reduce further kidney damage. We believe that DM199 can restore KLK1 levels and facilitate the production of protective nitric oxide, prostacyclin and anti-inflammatory mediators. In this way DM199 has the potential to:
- Restore Vasoregulation: Improve blood flow to the kidney by restoring proper regulation of blood flow through arteries, veins and especially capillaries;
- Decrease Inflammation: support the structural integrity of the kidney by reducing scar tissue formation (fibrosis), oxidative stress; and
- Activate mechanisms that upregulate T-regs, improve insulin sensitization, glucose uptake and glycogen synthesis.
DM199 CKD Phase Ib Study
DiaMedica Therapeutics is currently conducting a Phase Ib study in CKD patients to determine dose levels required to restore normal KLK1 protein levels and provide additional insights about the specific CKD patient populations that may benefit most from DM199 treatment. The results of this study will be used to guide the design of upcoming Phase II studies. This Phase Ib study conducted in the US, is a multi-center, open label clinical trial to evaluate the safety, tolerability and pharmacokinetics of three dose levels of DM199 in 32 patients with moderate and severe CKD.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing novel treatments for neurological and kidney diseases. DiaMedica’s common shares are listed on The Nasdaq Capital Market under the trading symbol “DMAC.”
For more information, please visit www.diamedica.com, or follow us on Twitter.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information that are based on the beliefs of management and reflect management’s current expectations. When used in this press release, the words “estimate”, “believe”, “anticipate”, “intend”, “expect”, “plan”, “will,” “may,” “can” or “should”, the negative of these words or such variations thereon or comparable terminology and the use of future dates are intended to identify forward-looking statements and information. The forward-looking statements and information in this press release include statements regarding the anticipated clinical success of DM199, the timing of its clinical programs, ability to achieve milestones and the sufficiency of its capital resources. Such statements and information reflect management’s current view and DiaMedica undertakes no obligation to update or revise any of these statements or information. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Applicable risks and uncertainties include, among others, DiaMedica’s plans to develop, obtain regulatory approval for and commercialize its DM199 product candidate for the treatment of CKD and AIS and its expectations regarding the benefits of DM199; DiaMedica’s ability to conduct successful clinical testing of DM199; the perceived benefits of DM199 over existing treatment options; ability to obtain required regulatory approvals; the potential size of the markets for DM199 and its ability to serve those markets; the success, cost and timing of planned clinical trials, as well as reliance on collaboration with third parties to conduct clinical trials; its ability to obtain funding for its operations, including funding necessary to complete planned clinical trials and obtain regulatory approvals for DM199 for CKD and AIS, and the risks identified under the heading “Risk Factors” in DiaMedica’s final prospectus filed with the U.S. Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) promulgated under the U.S. Securities Act of 1933, as amended, dated December 6, 2018, in connection with DiaMedica’s Registration Statement on Form S-1, as amended, its annual report on Form 10-K for the fiscal year ended December 31, 2018 and subsequent SEC filings by DiaMedica. The forward-looking information contained in this press release represents the expectations of DiaMedica as of the date of this press release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While DiaMedica may elect to, it does not undertake to update this information at any particular time except as required in accordance with applicable laws.
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