DiaMedica Therapeutics Announces Publication of Positive Clinical Results for DM199 in the International Journal of Clinical ...
08 November 2017 - 12:00AM
DiaMedica Therapeutics Inc. (the
“
Company”) (TSX Venture:DMA)
(OTCQB:DMCAF), a clinical stage biopharmaceutical company focused
on improving the lives of patients with neurological and kidney
diseases associated with low KLK1 levels, announced the publication
of positive results from its Phase Ib bridging trial. The study was
designed to compare the profile of DM199 to that of the approved
urinary KLK1 product (trade name Kailikang®) on the market in Asia
for acute ischemic stroke. The reference drug is administered
intravenously and has a very short pharmacokinetic profile. The
DiaMedica study identified an intravenous dose of DM199 having a
similar pharmacokinetic profile to urinary KLK1 along with a
superior subcutaneous dosing strategy.
The paper, entitled “Safety, tolerability, and
pharmacokinetic profile of recombinant human tissue kallikrein,
DM199, after intravenous and subcutaneous administration in healthy
volunteers”, established the pharmacokinetic profile of DM199 when
administered intravenously or subcutaneously in 36 healthy
volunteers. A 30-minute infusion delivered intravenously showed
rapid exposure of plasma DM199 with a short exposure window. A
single subcutaneous injection provided sustained exposure of plasma
DM199. The sustained plasma level of DM199 is superior to
Kailikang®. DM199 was safe and well tolerated following both routes
of administration with no treatment limiting adverse events. The
Company plans to use the results of this study to guide Phase II
dosing in upcoming clinical trials.
“We are happy to have the results of our recent
trial published in an important peer-reviewed journal. This
publication provides significant validation for the ongoing
clinical development of DM199,” said Dr. Todd Verdoorn, Chief
Scientific Officer of DiaMedica. “The results of the study fully
support our Phase II REMEDY trial that is designed to test the
action of DM199 in ischemic stroke patients.”
DM199 has the same amino acid sequence as the
reference drug, identical biochemical activity, and similar
physiological effects. The results from the Phase Ib study show
that the dosing of DM199 will be significantly more convenient and
potentially provide improved efficacy compared to the limited
exposure of the reference drug. This profile should allow DM199 to
be safely and conveniently administered to stroke patients during
their initial hospitalization and after they are sent home. The
sustained plasma exposure of DM199 should provide continuous enzyme
replacement therapy to optimally benefit patients and is
potentially superior to the urinary form of KLK1, Kailikang®, a
prescription drug approved in China for acute ischemic stroke.
About Acute Ischemic Stroke
An acute ischemic stroke is characterized by
rapid loss of brain function due to an interruption of blood supply
to the brain due to a blood clot. Affected areas of the brain
become inactive and cells eventually die causing neurological
impairment. Each year over 12 million people worldwide suffer an
acute ischemic stroke and it is the leading cause of death and
disability globally. The only approved U.S. Food and Drug
Administration (“FDA”) or European Medicines Agency (“EMA”) drug
treatment is tPA (Activase®) manufactured by Genentech.
However, only 5-7% of acute ischemic stroke patients are actually
treated with tPA due to eligibility and other issues.
About DM199
DM199 is a recombinant (synthetic) human tissue
kallikrein (“KLK1”) protein to treat neurological and kidney
diseases. DiaMedica has completed five clinical trials with DM199,
including single ascending and multiple ascending doses, studies in
diabetic patients, and a Phase I pharmacokinetic study to confirm
dosing strategies. In addition to a good safety and tolerability
profile, DM199 modestly reduced blood pressure in multiple studies
as expected based on its biochemical activity. DM199 also
significantly increased cerebral blood flow in a preclinical rat
study.
About DiaMedica Therapeutics
Inc.
DiaMedica Therapeutics is a clinical stage
biopharmaceutical company focused on developing novel treatments
for neurological and kidney diseases. DiaMedica’s shares are listed
on the TSX Venture Exchange under the trading symbol “DMA” and on
the OTCQB under the trading symbol “DMCAF”. For more information,
please visit www.diamedica.com. Follow us on
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For further information:Paul Papi
Vice President of Business Development 2 Carlson Parkway, Suite 260
Minneapolis, MN 55447 (617) 899-5941 info@diamedica.com
FORWARD-LOOKING STATEMENTS
The statements made in this press release that
are not historical facts contain forward-looking information that
involves risk and uncertainties. All statements, other than
statements of historical facts, which address DiaMedica’s
expectations, should be considered forward-looking statements. Such
statements are based on management’s exercise of business judgment
as well as assumptions made by and information currently available
to management. When used in this document, the words “may”, “will”,
“anticipate”, “believe”, “estimate”, “expect”, “intend” and words
of similar import, are intended to identify any forward-looking
statements. You should not place undue reliance on these
forward-looking statements. These statements reflect a current view
of future events and are subject to certain risks and uncertainties
as contained in the DiaMedica’s filings with the Canadian
securities regulators, all of which are available on SEDAR
(www.sedar.com). Should one or more of these risks
or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results could differ materially from those
anticipated in these forward-looking statements. DiaMedica
undertakes no obligation, and does not intend to update, revise or
otherwise publicly release any revisions to these forward-looking
statements to reflect events or circumstances after the date
hereof, or to reflect the occurrence of any unanticipated events,
unless required by law. Although management believes that
expectations are based on reasonable assumptions, no assurance can
be given that these expectations will materialize.
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.
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