DiaMedica Announces FDA Clearance of IND Application To Study DM199 in Patients with Chronic Kidney Disease
January 03 2019 - 6:30AM
DiaMedica Therapeutics Inc. (“DiaMedica”) (NASDAQ:DMAC) (TSX-V:DMA)
announced today that the U.S. Food and Drug Administration ("FDA")
has accepted DiaMedica’s Investigational New Drug application
("IND") for the initiation of a Phase Ib clinical trial of DM199 in
patients with moderate or severe Chronic Kidney Disease (“CKD”)
caused by Type I or Type II diabetes. The multi-site clinical study
will enroll 32 subjects to evaluate DM199 safety, tolerability and
drug levels (pharmacokinetics) in this specific population. The
study will enroll subjects over a 12 day period and will also
include other end points that include renal biomarkers.
The results from this Phase Ib study will assist
DiaMedica in the design of upcoming Phase II studies in patients
suffering from rare diseases and CKD. The DM199 drug levels from
this Phase Ib study will also help determine the optimal dose
levels for testing in the Phase II studies.
Dr. Harry Alcorn, DiaMedica’s Chief Medical Officer
commented, “The FDA has accepted our IND and protocol for the Phase
Ib study and we are excited to initiate our first clinical trial
with DM199 in patients with CKD caused by T1D or T2D in the United
States.” Dr Alcorn further commented “We believe that DM199 has the
potential to significantly improve the lives of patients with mild,
moderate or severe CKD and we look forward to performing the
clinical research required to evaluate DM199’s potential
benefits.”
We are very pleased with the clinical team’s
progress, both with finalizing the IND with the FDA and the
selection of key clinical trial sites that have the knowledge and
experience in conducting these types of studies in patients with
kidney disease,” commented Rick Pauls, DiaMedica’s Chief Executive
Officer. “We anticipate completing the Phase Ib study by mid-2019
and the Phase II study in Q4 2019 or Q1 2020.”
About CKD
CKD is a widespread health problem that generates
significant economic burden throughout the world. According to the
National Kidney Foundation, 30 million Americans and 120 million
Chinese suffer from this debilitating and potentially
life-threatening condition. CKD is a progressive condition causing
the kidneys to lose function over time, increasing the risk of
premature death, cardiovascular events, and hospitalization. End
stage renal disease (“ESRD”) is the final stage of CKD and requires
ongoing dialysis or a kidney transplant to survive, but many
patients suffer serious health consequences or die from CKD prior
to developing ESRD. Currently, there is no cure for CKD and
treatment focuses on managing the symptoms 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. Nevertheless, according to the National Kidney
Foundation, many patients continue to show declining kidney
function. DiaMedica believes DM199 offers a potentially novel
approach for the treatment of CKD by managing KLK1 levels, as this
protein plays a vital role in normal kidney function. Since
patients with moderate to severe CKD often excrete abnormally low
levels of KLK1 in their urine, DiaMedica believes that DM199 may
prevent or reduce further kidney damage by replenishing endogenous
KLK1 and restoring the protective kallikrein-kinin system to
regulate the production and release of nitric oxide and
prostacyclin.
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). 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
recombinant form of the KLK1 protein. The KLK1 protein, produced
from porcine (pig) pancreas and human urine, has been used to treat
patients in Japan, China and Korea. DM199 is currently being
studied in a Phase II trial in patients with acute ischemic
stroke.
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”
and on the TSX Venture Exchange under the trading symbol “DMA.”
For more information, please visit
www.diamedica.com, or follow us on Twitter
(https://twitter.com/diamedica). To be added to the Company’s email
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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” 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 design of the
clinical trials and the anticipated timing of the expected
completion of the Phase Ib and Phase II clinical trials. 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, dated December 6, 2018, in connection with
DiaMedica’s Registration Statement on Form S-1, as amended, 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.
Neither the TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of the contents of this press release.
IR 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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