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 Company has received further guidance from the U.S. Food
and Drug Administration (FDA) regarding the clinical hold on its
ReMEDy2 Phase 2/3 trial for the treatment of acute ischemic stroke
(AIS). The FDA stated it is maintaining its clinical hold at this
time and that additional non-clinical data related to the materials
used by a hospital in the IV infusion process is needed to resolve
the clinical hold.
In response to the FDA’s clinical hold letter in July 2022
related to three serious adverse event cases of transient acute
hypotension during intravenous infusion of DM199, the Company
previously submitted to the FDA supporting in vitro data that the
etiology (cause) is likely related to switching the type of
intravenous (IV) bag used in the prior ReMEDy 1 trial, where no
hypotensive episodes were reported, versus the current ReMEDy 2
trial. Hypotension is a known response to DM199 treatment.
Significant differences in protein binding were observed between
the two types of IV bags used in the studies that the Company
believes altered the total amount of drug being administered.
Following review of this data, the FDA requested an additional
in-use in vitro stability study of the IV administration of DM199
which includes the IV tubing and mechanical infusion pump to
further rule out any etiology other than IV bag protein binding.
Preparations for these in vitro studies are already underway and
the Company will request a Type A FDA meeting to confirm the study
design and obtain additional guidance towards lifting the clinical
hold and resuming the ReMEDy2 trial. The Company plans to provide
an update on the timing of completion of the in-use in-vitro study
and data submission following consultation with the FDA.
Rick Pauls, DiaMedica’s Chief Executive Officer, commented
“Patient safety remains our top priority. We believe that we now
have a clear path to resolving the clinical hold and we are highly
focused on resuming the ReMEDy2 trial as quickly as possible.”
The FDA placed a clinical hold on the Company’s Phase 2/3
ReMEDy2 trial following the Company voluntarily pausing patient
enrollment in the trial to investigate three unexpected instances
of clinically significant hypotension (low blood pressure)
occurring shortly after initiation of IV dose of DM199. The
hypotension was transient and blood pressure levels of all three
patients recovered back to baseline within minutes of stopping the
infusion and the patients suffered no ongoing adverse effects.
DiaMedica’s cash, cash equivalents and marketable securities as
of September 30, 2022 were $36.1 million resulting in a cash burn
of $2.3 million for the third quarter of 2022, down from a cash
burn of $2.6 million in the second quarter of 2022, reflecting
steps taken by the Company to conserve capital during the clinical
hold.
Conference Call and Webcast Information
DiaMedica Management will host a conference call and webcast to
discuss its ReMEDy2 update on Thursday, October 27, 2022, at 8:00
AM Eastern Time / 7:00 AM Central Time:
Date:
Thursday, October 27, 2022
Time:
8:00 AM ET / 7:00 AM CT
Web access:
https://events.q4inc.com/attendee/223964256
Dial In:
(888) 440-4368
Conference ID:
4814247
Interested parties may access the conference call by dialing in
or listening to the simultaneous webcast. Listeners should log on
to the website or dial in 15 minutes prior to the call. The webcast
will remain available for play back on DiaMedica’s website, under
investor relations - events and presentations, following the
earnings call and for 12 months thereafter. A telephonic replay of
the conference call will be available until November 3, 2022, by
dialing (800) 770-2030 (US Toll Free) and entering the replay
passcode: 4814247.
About 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 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 porcine pancreas 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) and patients with chronic kidney disease. 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. DiaMedica’s lead candidate
DM199 is the first pharmaceutically active recombinant (synthetic)
form of the KLK1 protein, an established therapeutic modality for
the treatment of acute ischemic stroke and chronic kidney disease.
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 “estimate,” “believe,”
“anticipate,” “intend,” “expect,” “plan,” “continue,” “potential,”
“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 Company’s
expectations regarding its ability to resolve the clinical hold
imposed by the FDA and its belief that the issues raised by the FDA
are potentially addressable, the resumption of the ReMEDy2 trial,
and the anticipated clinical benefits and success of DM199,
including being a potentially life changing drug to stroke
patients. 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, the risk that the Company may not know the cause of the
hypotension events that occurred in the ReMEDy2 trial or that its
plan to resolve the issues and prevent future events may not be
successful; the risk that the Company may not be able to address
successfully the concerns identified by the FDA or may require the
Company to collect additional data or information beyond what the
FDA has currently requested and what the Company currently expects;
the Company’s ability to successfully engage with the FDA and
satisfactorily respond to requests from the FDA for further
information and data regarding the ReMEDy2 trial and the timing and
outcome of the Company’s planned interactions with the FDA
concerning the clinical hold on the ReMEDy2 trial; the risk that
the Company may not be able to lift the clinical hold or do so in a
timely manner; uncertainties relating to regulatory applications
and related filing and approval timelines, including the risk that
FDA may not remove the clinical hold on the ReMEDy2 trial; 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 the COVID-19 pandemic,
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, 2021 and subsequent U.S. Securities and Exchange
Commission filings, including its quarterly report on Form 10-Q for
the quarterly period ended June 30, 2022. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221026006012/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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