DiaMedica Therapeutics Doses First Patient in Phase 1b Clinical Study of DM199 in Patients with Chronic Kidney Disease
February 14 2019 - 8:00AM
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage
biotechnology company, today announced that it has initiated dosing
patients with chronic kidney disease (“CKD”) in a Phase Ib clinical
study evaluating DM199. The Phase 1b 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.
“This study will assist in determining dose levels
required to restore normal KLK1 protein levels in patients with CKD
and provide additional insights about the specific CKD patient
populations that may benefit most from DM199 treatment and to guide
the design of upcoming Phase II studies,” said Dr. Harry
Alcorn, Chief Medical Officer at DiaMedica Therapeutics. “We are
excited about the potential for DM199 to provide a positive benefit
to patients with CKD as we commence our US clinical studies.”
Chronic kidney disease is a widespread health
problem that generates significant economic burden throughout the
world, including 30 million people in the US who suffer from this
debilitating and potentially life-threatening condition according
to the National Kidney Foundation. The primary causes of CKD are
diabetes (Type 1 and Type 2) and hypertension. CKD is also caused
by several other health conditions that can damage your kidneys and
lead to CKD and end stage renal disease including lupus nephritis,
polycystic kidney disease, interstitial nephritis,
glomerulonephritis, acute kidney injury and focal segmental
glomerulosclerosis.
DM199 for Chronic Kidney
Disease
Currently, there is no cure for CKD and treatment
involves management of the 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.
The Company’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. DiaMedica believes that DM199 may prevent or reduce further
kidney damage by replenishing KLK1 levels and restoring systems
that prevent ongoing kidney damage. KLK1 can facilitate the
production of protective nitric oxide, prostacyclin and
anti-inflammatory mediators. In this way DM199 has the has
the potential to:
- Improve blood flow to the kidney by restoring proper regulation
of blood flow through arteries, veins and especially capillaries
(vasoregulation);
- Support the structural integrity of the kidney by reducing scar
tissue formation (fibrosis), oxidative stress, and inflammation;
and
- Activate mechanisms that upregulate T-regs, improve insulin
sensitization, glucose uptake and glycogen synthesis.
About DM199
DM199 is a recombinant form of human tissue
kallikrein-1 (“KLK1”). KLK1 is an endogenous serine protease
(protein) produced in the kidneys, pancreas and salivary glands,
which plays a critical role in the regulation of local blood flow
and vasodilation (the widening of blood vessels which decreases
blood pressure) in the body, as well as an important role in
managing inflammation and oxidative stress (an imbalance between
potentially damaging reactive oxygen species, or free radicals, and
antioxidants in your body). Scientific reports suggest that KLK1
deficiency may play a role in multiple vascular and fibrotic
diseases such as chronic kidney disease, retinopathy, stroke,
vascular dementia and resistant hypertension where current
treatment options are limited or ineffective. DiaMedica is the
first company to have developed a pharmacologically active
recombinant form of the KLK1 protein. The KLK1 proteins, produced
from porcine (pig) pancreas and human urine, have been used to
treat patients in Japan, China and Korea.
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 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” or
“should”, “potential”, 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. The
forward-looking statements in this press release include statements
regarding the expectation that KLK1 may improve outcomes in
patients suffering from CKD. 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 its expectations regarding
the benefits of DM199; DiaMedica’s ability to conduct successful
clinical testing of DM199 for CKD; the perceived benefits of DM199
over existing treatment options for CKD; ability to obtain required
regulatory approvals of DM199 for CKD; 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 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, on December 10, 2018, in connection with
DiaMedica’s Registration Statement on Form S-1, as amended, and
subsequent SEC filings by DiaMedica. The forward-looking statements
in this press release represent 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 statements and should not rely upon them as of
any other date. While DiaMedica may elect to, it does not undertake
to update these statements at any particular time except as
required in accordance with applicable laws.
Contact:
Paul Papi Vice President of Business Development
DiaMedica Therapeutics Inc. Two Carlson Parkway, Suite 260
Minneapolis, MN Phone: (617) 899-5941 info@diamedica.com
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