DiaMedica Announces First Patients Dosed in Diabetic Kidney Disease Cohort in Phase II REDUX CKD Clinical Study
September 14 2020 - 9:15AM
Business Wire
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage
biopharmaceutical company developing novel treatments for chronic
kidney disease, today announced dosing of the first participants in
the diabetic kidney disease (DKD) cohort of the REDUX Phase II
Chronic Kidney Disease (CKD) study. In total, 16 additional
participants have been enrolled in the REDUX study in the past six
weeks, 11 of which were enrolled in the DKD cohort III, bringing
the total enrolled participants to 34, including 11 African
American subjects into cohort I and 12 subjects with IgA
Nephropathy (IgAN) into cohort II of the REDUX study.
“We are very pleased with the recent uptick in enrollments in
the REDUX trial and with the ability of our current study sites to
identify, screen and enroll DKD participants,” commented Dr. Harry
Alcon, Jr., Chief Medical Officer of DiaMedica Therapeutics, “we
are further encouraged by these enrollments given that
approximately half of our study sites remain unable to enroll new
subjects as they continue to struggle with restrictions related to
COVID-19. At this time, we are hopeful recruitment continues to
improve; however, with the flu season approaching and COVID-19
still in play, we will continue to monitor and support our sites
for enrollment.”
The Phase II REDUX clinical trial is a multi-center, open-label
investigation targeting 90 participants with Stage II or III CKD,
who will be enrolled in three equal cohorts. The study is being
conducted in the United States at up to 13 sites. Cohort I is
studying African Americans with hypertension but who are not
diabetic. African Americans are at greater risk for CKD than
Caucasians and those who have the APOL1 gene mutation are at an
even higher risk. The study is designed to capture APOL1 gene
mutation as an exploratory biomarker in this cohort. Cohort II is
studying participants with IgA Nephropathy previously confirmed by
biopsy. Cohort III is studying participants with Type II diabetes
mellitus, hypertension and albuminuria.
The REDUX study is evaluating two dose levels of DM199 within
each cohort. Study participants will receive DM199 by subcutaneous
injection twice weekly for 95 days. The primary study endpoints
include safety, tolerability, blood pressure, albuminuria and
kidney function, which will be evaluated by changes from baseline
in eGFR and albuminuria, as measured by the urinary albumin to
creatinine ratio (UACR). Secondary endpoints are focused on
evaluating the potential for DM199 to positively impact the
underlying disease causing each participant’s kidney disease.
About DM199
DM199 is a recombinant (synthetic) form of human tissue
kallikrein-1 (KLK1). KLK1 is a serine protease (protein) that plays
an important role in the regulation of diverse physiological
processes including blood flow, inflammation, fibrosis, oxidative
stress and neurogenesis via a molecular mechanism that increases
production of nitric oxide and prostaglandin. 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 pancreas and human urine, has been used to treat
patients in Japan, China and Korea for decades. DM199 is currently
being studied in patients with chronic kidney disease and 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.”
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 “may,” “expects,” “intends,”
“estimates”, “believes”, “anticipates”, “plans”, “continue,”
“will”, 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, but not limited to, the
anticipated clinical benefits and success of DM199 and plans with
respect to enrollment in the REDUX study. By their nature,
forward-looking statements involve known and unknown risks,
uncertainties and other factors which may cause 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 ability to conduct successful clinical testing
of DM199 and within its anticipated parameters, costs and
timeframes; the perceived benefits of DM199 over existing treatment
options; the potential direct or indirect impact of the COVID-19
pandemic on enrollment in the REDUX study and DiaMedica’s business;
its reliance on collaboration with third parties to conduct
clinical trials; its ability to continue to obtain funding for its
operations, and the risks identified under the heading “Item 1.A.
Risk Factors” in DiaMedica’s annual report on Form 10-K for the
fiscal year ended December 31, 2019 as filed with the SEC on March
23, 2020 and subsequent SEC filings by DiaMedica, including its
quarterly report on Form 10-Q for the quarterly period ended June
30, 2020 as filed with the SEC on August 11, 2020. 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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version on businesswire.com: https://www.businesswire.com/news/home/20200914005212/en/
Scott Kellen Chief Financial Officer Phone: (763) 496-5118
skellen@diamedica.com
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