DiaMedica Announces Top-line Results of Phase IIa Clinical Trial of DM199 for Type 2 Diabetes
MINNEAPOLIS, MINNESOTA--(Marketwired - Nov 17, 2014) - DiaMedica Inc. (TSX VENTURE:DMA) today announced top-line results of its Phase IIa proof of concept clinical trial of DM199 in patients with type 2 diabetes. DM199 is a recombinant form of the human tissue kallikrein-1 protein (rhKLK1).
The Company’s Phase IIa clinical trial met its primary endpoint. The study demonstrated that DM199 was safe and well tolerated following administration to patients by subcutaneous injection (beneath the skin). Based on the Company’s initial assessment, DM199 treatment did not achieve the secondary objectives of improvement in glucose control.
“We are still completing our analysis of the full data set from this study to then use this information to plan for further studies,” stated Rick Pauls, President & CEO. “We will continue the development of DM199 for acute intravenous indications that include complications from diabetes, acute kidney and cardiovascular disorders.”
The randomized, placebo-controlled, double-blind study enrolled a total of 37 patients with type 2 diabetes, 35 of whom completed the entire 28-day study. Prior to the study, patients completed a 28-day wash out of their diabetes medications and then were sequestered for the month-long study. Patients were randomly assigned to receive subcutaneous doses of either 3 or 15 (micro)g/kg of DM199 or placebo once every 72 hours.
About DiaMedica
DiaMedica is a publicly traded (TSX VENTURE:DMA) development stage biopharmaceutical company focused on the discovery and development of novel approaches to treat unmet diseases. DiaMedica’s lead product, DM199, is recombinant human tissue kallikrein-1 protein (rhKLK1). DiaMedica’s common shares are listed on the TSX Venture Exchange in Canada under the trading symbol ‘DMA’.
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. Forward looking statements in this news release include, but are not limited to, the size and price of the Offering, the Company’s objectives, goals, future plans and statements regarding the Offering and the use of proceeds therefrom, the expected closing date of the Offering and obtaining Exchange approval for the Offering. Factors that could cause actual results to differ materially from such forward-looking information include, but are not limited to: the need to satisfy regulatory and legal requirements with respect to the proposed Offering; uncertainties associated with satisfying all remaining contractual obligations of the Phase II study and DM199 in patients with type 2 diabetes; uncertainties associated with the Offering size and price of Units; uncertainties in obtaining listing approval of the Common Shares from the Exchange; changes in equity markets and inflation; and the additional risk factors described in detail in the Prospectus and DiaMedica’s other 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.
Contact:
DiaMedica Inc.
Rick Pauls
President & CEO
763-270-0603
info@diamedica.com
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