DM199 for Acute Ischemic Stroke (AIS)

Potential to Treat More Stroke Patients

DM199 aims to protect valuable brain tissue during the hours to weeks after an acute ischemic stroke (AIS). DM199 promotes microcirculation at the site of the clot when taken up to 24 hours after the onset of stroke symptoms. Not only can DM199 be administered up to 24 hours post onset of stroke, (treatment window longer than any existing therapies) , but it 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.


Program Asset Route of Admin Development Stage
Preclinical Phase 1 Phase 2 Pivotal
Acute Ischemic Stroke (AIS): Stroke Recovery & Stroke Recurrence DM199 IV/SC
ReMEDy2 Pivotal Phase 2/3 Preclinical complete
Phase 1 complete
Phase 2 complete
Pivotal in progress

About Acute Ischemic Stroke (AIS)

Acute ischemic stroke (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 AIS.

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 “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

  • 15 million strokes per year globally
  • 800,000 strokes per year in the U.S.
  • 87% are acute ischemic strokes
  • ~600,000: U.S. target market
  • ~90% of AIS patients have no direct treatment options

Mechanism of Action

DM199/KLK1 supports the production of nitric oxide and prostaglandins which act in tandem to improve vascular health. Locally delivered/activated when and as needed