DiaMedica Therapeutics Hosting Key Opinion Leader Webinar on DM199 for Treatment of Acute Ischemic Stroke

Rhea-AI Summary

DiaMedica Therapeutics Inc. (Nasdaq: DMAC) will host a KOL webinar on DM199, its leading asset for Acute Ischemic Stroke (AIS) treatment, on March 19, 2021. Key opinion leaders Scott Kasner, M.D., and Paolo Madeddu, M.D., will discuss treatment gaps and DM199's potential benefits. Management will update on DM199, a synthetic form of human tissue kallikrein-1, which showed a statistically significant 86% reduction in severe recurrent strokes in a recent study. An IND application for a phase 2/3 study is planned for Q1 2021.

Positive

• Statistically significant 86% reduction in severe recurrent strokes observed in the ReMEDy Phase 2 study.
• 36% full or nearly full recovery at 90 days among DM199 treated patients versus 14% in placebo.
• 50% reduction in mortality: 12% in DM199 group compared to 24% in placebo.

Negative

• None.

DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical stage biopharmaceutical company developing novel treatments for neurological and kidney diseases, today announced that it will host a key opinion leader (KOL) webinar on DM199, the Company’s lead asset for the treatment of Acute Ischemic Stroke (AIS), on Friday, March 19, 2021 at 12:00pm Eastern Time.

The webinar will feature presentations by KOLs Scott Kasner, M.D., University of Pennsylvania, and Paolo Madeddu, M.D., University of Bristol, who will discuss the current treatment landscape and unmet medical need in treating patients with AIS and the rationale for the treatment of stroke and stroke recurrence with DM199. Drs. Kasner and Madeddu will be available to answer questions following the formal presentations.

DiaMedica Therapeutics' management team will also provide an update on the product candidate DM199 for acute ischemic stroke and stroke recurrence prevention. DM199 is a recombinant (synthetic) form of the 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.

DiaMedica plans to submit an investigational new drug (IND) application to the FDA for the phase 2/3 study in the first quarter of 2021.

To register for the webinar, please click here.

Dr. Scott E. Kasner earned his B.S. in Physics and Zoology from Duke University, M.D. from Yale University, and a Master’s of Science in Clinical Epidemiology (M.S.C.E.) from the University of Pennsylvania. He trained in Neurology at the University of Pennsylvania, and then in Stroke and Neurocritical Care at the University of Texas at Houston. He joined the faculty at the University of Pennsylvania in 1997 and is currently the Ruth M. & Tristram C. Colket Jr. President’s Distinguished Professor of Neurology, Chief of the Division of Stroke and Cerebrovascular Disease, Vice Chair for Clinical Affairs, and Director of the Joint Commission-certified Comprehensive Stroke Center. He is a Fellow of the American Heart Association and was a longstanding member of its Stroke Council Leadership Committee. He chaired the AHA’s Stroke Oversight Committee and the Early Career Investigator committee. He was awarded the 2000 Michael Pessin Stroke Leadership Award by the American Academy of Neurology and the 2012 Stroke Council Award by the American Heart Association. Dr. Kasner has had leadership roles in many trials of novel interventions for acute stroke treatment, prevention, and recovery. He has authored over 300 publications, and he edited 2 textbooks focused on evidence-based stroke care. Dr. Kasner has been extolled as a teacher and mentor, with several teaching awards spanning his career.

Prof. Paolo Madeddu, M.D. is Professor in Experimental Cardiovascular Medicine at the University of Bristol Medical School and is a globally recognized Key Opinion Leader regarding research on the KLK1 mechanism. Most recently, Prof. Madeddu was Head of Regenerative Medicine Section in the School of Clinical Sciences at the University of Bristol. Prior to that, he was Director of Experimental Medicine and Gene Therapy at Osilo and Alghero Technological Park.

Prof. Madeddu received his M.D. from the University of Sassari where he graduated Magna cum laude and was awarded the title of "Doctor in Medicine and Surgery". He was awarded many grants as a personal investigator and is currently working on 4 ongoing grants as a co-personal investigator. Additionally, Prof. Madeddu is the author of over 300 publications.

About DM199 for Acute Ischemic Stroke

On average, someone in the United States has a stroke every 40 seconds and someone dies from a stroke every four minutes. AIS is the leading cause of adult disability in the United States and costs the United States an estimated $34 billion annually, including the cost of health care services, medications and lost productivity.

The Company’s recently completed ReMEDy Phase 2 study in AIS (N=91), in addition to meeting its primary safety and tolerability endpoints, a statistically significant 86% (P=0.028) reduction in the number of participants with severe recurrent strokes was observed in the active treatment group (N=1) compared to placebo (N=7), a potentially transformative outcome given that approximately 25% of the 795,000 strokes occurring each year in the United States are recurrent strokes.

Additionally, in a subset of participants in the ReMEDy study that most closely represents the proposed targeted study population for DM199 (N=46), 36% of participants receiving DM199 (N=25) achieved a full or nearly full recovery at 90 days, an NIHSS score of 0-1, compared to 14% in the placebo group (N=21), an absolute difference of 22%. This subset was comprised of those participants not receiving a mechanical thrombectomy, indicative of a large vessel occlusion, prior to enrollment. Additionally, deaths in the DM199 group (N=25) were 12% compared to 24% in the placebo group (N=21), an absolute reduction of 50%. The combination of improvement in recoveries and reduction in recurrent strokes creates an encouraging signal for the potential benefit of DM199 to AIS patients and supports the further investigation of DM199 in AIS.

About DM199

DM199 is a recombinant (synthetic) form of the 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 including stroke, stroke recurrences, kidney diseases, vascular dementia and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein for clinical use. The KLK1 protein, produced from human urine and porcine pancreas, has been used to treat patients in Japan, China and Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and chronic kidney diseases.

About DiaMedica Therapeutics Inc.

DiaMedica Therapeutics Inc. (Nasdaq: DMAC) is a clinical stage biopharmaceutical company focused on developing novel treatments to improve the lives of patients with neurological and chronic kidney diseases. To learn more about DiaMedica, visit www.diamedica.com.

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FAQ

What is the significance of the KOL webinar for DMAC on March 19, 2021?

The KOL webinar highlights DM199's potential for treating Acute Ischemic Stroke and discusses its transformative trial results.

What were the results of the ReMEDy Phase 2 study for DM199?

The ReMEDy study showed an 86% reduction in severe recurrent strokes and improved recovery rates for patients treated with DM199.

What is the mechanism of action for DM199?

DM199 is a recombinant form of human tissue kallikrein-1, which regulates blood flow, inflammation, and neurogenesis.

When does DiaMedica plan to submit the IND application for DM199?

DiaMedica plans to submit the IND application for the phase 2/3 study of DM199 in the first quarter of 2021.