DiaMedica Therapeutics, Inc.

DM199 for Acute Ischemic Stroke (AIS)

Potential to Treat More Stroke Patients

Our investigational drug product candidate, DM199 (rinvecalinase alfa), aims to preserve valuable brain tissue during the hours to weeks after an acute ischemic stroke (AIS). DM199 is intended to promote collateral circulation in the ischemic penumbra following a stroke and is being clinically studied with treatment initiated up to 24 hours after the onset of stroke symptoms. This is a treatment window five times longer than any existing therapy. DM199, as a protein replacement therapy, may also be a safer alternative for patients who are excluded from other treatment options because of clot location, delayed arrival at the emergency department or other safety considerations.

Pipeline

Indication Compound Route of Admin Development Stage
Preclinical Phase 1 Phase 2 Phase 2/3
Neurological
Acute Ischemic Stroke DM199 (rinvecalinase alfa) IV/SC
ReMEDy2 Study Preclinical complete
Phase 1 complete
Phase 2 complete
Phase 2/3 in progress

About Acute Ischemic Stroke (AIS)

AIS is characterized by the rapidly developing loss of brain function due to a blockage of blood flow to the brain.  According to the U.S. Center for Disease Control, stroke causes approximately one out of every 20 deaths in the U.S. each year.  Nearly nine out of 10 strokes are ischemic.

When a blood vessel in the brain becomes blocked during a stroke, a core area of the affected brain tissue will typically suffer a nearly complete loss of blood flow, with a surrounding area (the “ischemic penumbra”) experiencing a partial loss of blood flow. Cells in the core area rapidly depleted of their oxygen and glucose stores leading, often within minutes, to cell death. The cells in the penumbral area may remain viable for several hours but are eventually at risk of tissue damage from reduced oxygen and glucose availability and compression resulting from fluid buildup in the brain.

A stroke can lead to permanent brain damage, including memory loss, speech problems, reading and comprehension difficulties, physical disabilities, and emotional/behavioral problems.  Many patients require extended hospitalization, physical therapy or rehabilitation, or long-term institutional or family care.

Market Need

  • >7.5 million ischemic strokes per year globally1
  • ~700,000 ischemic strokes per year in the U.S.2
  • ~500,000 ischemic stroke patients: U.S. target market3
  • ~80% of AIS patients have no direct treatment options3

1. World Stroke Organization Global Fact Sheet 2022.
2. CDC Stroke Facts October 2022.
3. Market research conducted by SyneosOne in 2020 and Journal of Stroke and Cerebrovascular Diseases, Volume 29, Issue 2, February 2020

Replenishing KLK1 Levels

DM199 (rhKLK1) therapy is intended to increase production of bradykinin which in turn activates a greater number of the increased bradykinin 2 receptors present in arteries affected by AIS, referred to as the ischemic penumbra, thus improving collateral circulation in the ischemic penumbra. By delivering vital oxygen and nutrients to brain tissues in need, there is the potential to preserve/restore neuronal function and reducing the size of the ischemic penumbra, minimizing tissue death (infarction) and brain damage.

The safety and effectiveness of DM199 for the treatment of acute ischemic stroke or preeclampsia has not been established and is limited to investigational use only.