DiaMedica Therapeutics to Present at CKD3 Kidney Summit Meeting
April 30 2019 - 4:58PM
DiaMedica Therapeutics Inc. (Nasdaq: 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.
Contact:
Scott KellenChief Financial OfficerPhone: (763)
496-5118 skellen@diamedica.com
Paul Papi Vice President of Business Development
Phone: (617) 899-5941 info@diamedica.com
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