{"id":765060,"date":"2023-06-21T08:29:49","date_gmt":"2023-06-21T12:29:49","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/diamedica-therapeutics-announces-that-the-fda-has-removed-the-clinical-hold-on-dm199-phase-2-3-trial-for-ischemic-stroke\/"},"modified":"2023-06-21T08:29:49","modified_gmt":"2023-06-21T12:29:49","slug":"diamedica-therapeutics-announces-that-the-fda-has-removed-the-clinical-hold-on-dm199-phase-2-3-trial-for-ischemic-stroke","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/diamedica-therapeutics-announces-that-the-fda-has-removed-the-clinical-hold-on-dm199-phase-2-3-trial-for-ischemic-stroke\/","title":{"rendered":"DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2\/3 Trial For Ischemic Stroke"},"content":{"rendered":"

<\/p>\n

DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2\/3 Trial For Ischemic Stroke<\/b><\/p>\n

MINNEAPOLIS–(BUSINESS WIRE<\/a>)–
\nDiaMedica 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.<\/p>\n

\n\u201c\u200bWe are pleased that the FDA has fully lifted the clinical hold. \u200bDM199, 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,\u201d said Rick Pauls, DiaMedica\u2019s President and CEO.<\/p>\n

\n\u201cWe 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,\u201d said Kirsten Gruis, MD, DiaMedica\u2019s Chief Medical Officer.<\/p>\n

About the ReMEDy2 Trial<\/b><\/p>\n

\nThe ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of the Company\u2019s 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.<\/p>\n

About DM199<\/b><\/p>\n

\nDM199 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.<\/p>\n

About DiaMedica Therapeutics Inc.<\/b><\/p>\n

\nDiaMedica 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\u2019s 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\u2019s website at www.diamedica.com<\/a>.<\/p>\n

Cautionary Note Regarding Forward-Looking Statements<\/b><\/p>\n

\nThis 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\u2019s current expectations. When used in this press release, the words \u201canticipates,\u201d \u201cbelieves,\u201d \u201clook forward,\u201d \u201ccontinue,\u201d \u201ccould,\u201d \u201cestimates,\u201d \u201cexpects,\u201d \u201cintends,\u201d \u201cmay,\u201d \u201cplans,\u201d \u201cpotential,\u201d \u201chope,\u201d \u201cshould,\u201d or \u201cwill,\u201d 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\u2019s expectations regarding the resumption of the ReMEDy2 trial and the anticipated clinical benefits and success of DM199. Such statements and information reflect management\u2019s 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\u037e the possibility of additional future adverse events associated with or unfavorable results from the ReMEDy2 trial\u037e the possibility of unfavorable results from DiaMedica\u2019s ongoing or future clinical trials of DM199\u037e the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials\u037e DiaMedica\u2019s 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\u037e DiaMedica\u2019s ability to conduct successful clinical testing of DM199 and within its anticipated parameters, enrollment numbers, costs and timeframes\u037e 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\u037e the perceived benefits of DM199 over existing treatment options\u037e the potential direct or indirect impact of COVID-19, hospital and medical facility staffing shortages, and worldwide global supply chain shortages on DiaMedica\u2019s business and clinical trials, including its ability to meet its site activation and enrollment goals\u037e DiaMedica\u2019s reliance on collaboration with third parties to conduct clinical trials\u037e DiaMedica\u2019s 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 \u201cRisk Factors\u201d in DiaMedica\u2019s 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\u2019s 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.<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20230621362057\/en\/<\/a><\/span><\/p>\n

\nScott Kellen
\n
Chief Financial Officer
\n
Phone: (763) 496-5118
\n
skellen@diamedica.com<\/a><\/p>\n

\nPaul Papi
\n
Corporate Communications
\n
Phone: 617-899-5941
\n
ppapi@diamedica.com<\/a><\/p>\n

KEYWORDS:<\/b> United States North America Minnesota<\/p>\n

INDUSTRY KEYWORDS:<\/b> FDA Health Clinical Trials Pharmaceutical Cardiology Biotechnology<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
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DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2\/3 Trial For Ischemic Stroke MINNEAPOLIS–(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. \u201c\u200bWe are pleased that the FDA has fully lifted the clinical hold. \u200bDM199, a synthetic formulation of the human tissue-1 kallikrein protein (KLK1), represents a novel … <\/p>\n

Continue reading “DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2\/3 Trial For Ischemic Stroke”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-765060","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nDiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2\/3 Trial For Ischemic Stroke - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/diamedica-therapeutics-announces-that-the-fda-has-removed-the-clinical-hold-on-dm199-phase-2-3-trial-for-ischemic-stroke\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2\/3 Trial For Ischemic Stroke - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2\/3 Trial For Ischemic Stroke MINNEAPOLIS–(BUSINESS WIRE)– DiaMedica Therapeutics Inc. 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(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. \u201c\u200bWe are pleased that the FDA has fully lifted the clinical hold. \u200bDM199, a synthetic formulation of the human tissue-1 kallikrein protein (KLK1), represents a novel … Continue reading \"DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2\/3 Trial For Ischemic Stroke\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/diamedica-therapeutics-announces-that-the-fda-has-removed-the-clinical-hold-on-dm199-phase-2-3-trial-for-ischemic-stroke\/","og_site_name":"Market Newsdesk","article_published_time":"2023-06-21T12:29:49+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20230621362057r1&sid=flmnd&distro=nx&lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/diamedica-therapeutics-announces-that-the-fda-has-removed-the-clinical-hold-on-dm199-phase-2-3-trial-for-ischemic-stroke\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/diamedica-therapeutics-announces-that-the-fda-has-removed-the-clinical-hold-on-dm199-phase-2-3-trial-for-ischemic-stroke\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2\/3 Trial For Ischemic Stroke","datePublished":"2023-06-21T12:29:49+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/diamedica-therapeutics-announces-that-the-fda-has-removed-the-clinical-hold-on-dm199-phase-2-3-trial-for-ischemic-stroke\/"},"wordCount":1205,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/diamedica-therapeutics-announces-that-the-fda-has-removed-the-clinical-hold-on-dm199-phase-2-3-trial-for-ischemic-stroke\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20230621362057r1&sid=flmnd&distro=nx&lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/diamedica-therapeutics-announces-that-the-fda-has-removed-the-clinical-hold-on-dm199-phase-2-3-trial-for-ischemic-stroke\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/diamedica-therapeutics-announces-that-the-fda-has-removed-the-clinical-hold-on-dm199-phase-2-3-trial-for-ischemic-stroke\/","name":"DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2\/3 Trial For Ischemic Stroke - 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