DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2/3 Trial For Ischemic Stroke
21 Junio 2023 - 7:15AM
Business Wire
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage
biopharmaceutical company focused on developing novel treatments
for neurological disorders and kidney diseases, announced today
that the U.S. Food and Drug Administration (FDA) has removed the
clinical hold placed on the investigational new drug application
for its ReMEDy2 phase 2/3 clinical trial studying DM199 in the
treatment of acute ischemic stroke (AIS) and that preparations are
underway to resume the ReMEDy2 trial as soon as possible.
“We are pleased that the FDA has fully lifted the clinical
hold. DM199, a synthetic formulation of the human tissue-1
kallikrein protein (KLK1), represents a novel approach to treating
AIS patients, principally aimed at enhancing collateral blood flow
in the brain tissues affected by the stroke,” said Rick Pauls,
DiaMedica’s President and CEO.
“We look forward to re-engaging with our study sites and stroke
expert principal investigators as we resume our ReMEDy2 trial as
there is continued unmet need of new potential therapeutics for
patients who have had an ischemic stroke,” said Kirsten Gruis, MD,
DiaMedica’s Chief Medical Officer.
About the ReMEDy2 Trial
The ReMEDy2 trial is an adaptive design, randomized,
double-blind, placebo-controlled trial studying the use of the
Company’s product candidate, DM199, to treat acute ischemic stroke
(AIS) patients. The trial is intended to enroll approximately 350
patients at 75 sites in the United States. Patients enrolled in the
trial will be treated for three weeks with either DM199 or placebo,
beginning within 24 hours of the onset of AIS symptoms, with the
final follow-up at 90 days. The trial excludes patients treated
with tissue plasminogen activator (tPA) and/or mechanical
thrombectomy. The study population is representative of the
approximately 80% of AIS patients who do not have treatment options
today, primarily due to the limitations on treatment with tPA or
mechanical thrombectomy. DiaMedica believes that the proposed trial
has the potential to serve as a pivotal registration study of DM199
in this patient population.
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
stroke, chronic kidney disease, retinopathy, vascular dementia, and
resistant hypertension where current treatment options are limited
or ineffective. DiaMedica is the first company to have developed
and clinically studied a recombinant form of the KLK1 protein. The
KLK1 protein, produced from the pancreas of pigs and human urine,
has been used to treat patients in Japan, China and South Korea for
decades. DM199 is currently being studied in patients with acute
ischemic stroke (AIS). In September 2021, the FDA granted Fast
Track Designation to DM199 for the treatment of AIS.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical stage
biopharmaceutical company committed to improving the lives of
people suffering from serious diseases with a focus on acute
ischemic stroke. DiaMedica’s lead candidate DM199 is the first
pharmaceutically active recombinant (synthetic) form of the KLK1
protein, an established therapeutic modality in Asia for the
treatment of acute ischemic stroke and other vascular diseases. For
more information visit the Company’s website at
www.diamedica.com.
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 “anticipates,” “believes,”
“look forward,” “continue,” “could,” “estimates,” “expects,”
“intends,” “may,” “plans,” “potential,” “hope,” “should,” or
“will,” 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 Company’s expectations regarding
the resumption of the ReMEDy2 trial and the anticipated clinical
benefits and success of DM199. 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 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, uncertainties relating to regulatory
applications and related filing and approval timelines; the
possibility of additional future adverse events associated with or
unfavorable results from the ReMEDy2 trial; the possibility of
unfavorable results from DiaMedica’s ongoing or future clinical
trials of DM199; the risk that existing preclinical and clinical
data may not be predictive of the results of ongoing or later
clinical trials; DiaMedica’s plans to develop, obtain regulatory
approval for and commercialize its DM199 product candidate for the
treatment of acute ischemic stroke and chronic kidney disease and
its expectations regarding the benefits of DM199; DiaMedica’s
ability to conduct successful clinical testing of DM199 and within
its anticipated parameters, enrollment numbers, costs and
timeframes; the adaptive design of the ReMEDy2 trial and the
possibility that the targeted enrollment and other aspects of the
trial could change depending upon certain factors, including
additional input from the FDA and the blinded interim analysis; the
perceived benefits of DM199 over existing treatment options; the
potential direct or indirect impact of COVID-19, hospital and
medical facility staffing shortages, and worldwide global supply
chain shortages on DiaMedica’s business and clinical trials,
including its ability to meet its site activation and enrollment
goals; DiaMedica’s reliance on collaboration with third parties to
conduct clinical trials; DiaMedica’s ability to continue to obtain
funding for its operations, including funding necessary to complete
planned clinical trials and obtain regulatory approvals for DM199
for acute ischemic stroke and chronic kidney disease, and the risks
identified under the heading “Risk Factors” in DiaMedica’s annual
report on Form 10-K for the fiscal year ended December 31, 2022 and
subsequent U.S. Securities and Exchange Commission filings,
including DiaMedica’s quarterly report on Form 10-Q for the
quarterly period ended March 31, 2023. 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/20230621362057/en/
Scott Kellen Chief Financial Officer Phone: (763) 496-5118
skellen@diamedica.com
Paul Papi Corporate Communications Phone: 617-899-5941
ppapi@diamedica.com
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