Rinvecalinase alfa

Table of contents

• What is rinvecalinase alfa?
• How does rinvecalinase alfa work?
• Which conditions is it used or studied for?
• How is rinvecalinase alfa given?
• What do the clinical trials show?
• What side effects are known?

What is rinvecalinase alfa?

Rinvecalinase alfa is an investigational substance also known by its development code DM199. It is being studied for the treatment of acute ischemic stroke, a condition where a blood clot blocks a blood vessel in the brain, cutting off the blood supply. The substance is given by parenteral use, meaning it is administered by injection rather than by mouth.^[1]

How does rinvecalinase alfa work?

The exact mechanism of action of rinvecalinase alfa is not described in the registry data for this trial. The study focuses on participants with moderate stroke severity who present within 24 hours of acute ischemic stroke onset or last known normal due to small and medium vessel occlusions. These are participants who have limited treatment options.^[1]

Which conditions is it used or studied for?

• Acute ischemic stroke — a sudden blockage of a blood vessel in the brain, which can cause lasting disability if blood flow is not restored quickly.

How is rinvecalinase alfa given?

Rinvecalinase alfa is given by parenteral use, meaning it is injected rather than taken by mouth. In the trial, the dose being studied is 548 micrograms.^[1]

What do the clinical trials show?

One Phase 4 clinical trial is currently authorised to investigate rinvecalinase alfa in acute ischemic stroke. The trial plans to enrol 728 participants.^[1]

The study is interventional, meaning participants receive the treatment and are then followed over time. It compares rinvecalinase alfa against a placebo — a product containing the same ingredients except the active substance.^[1]

The main measure of the trial is stroke recovery at Day 90, assessed using the modified Rankin Score (mRS). A score of 0 or 1 on this scale, which ranges from 0 to 6, is considered an excellent functional outcome. The trial also measures the incidence, severity and causality of adverse events and serious adverse events, as well as changes in physical examination, vital signs, blood tests and electrocardiogram (ECG).^[1]

Participants who have or will receive mechanical thrombectomy — a procedure to physically remove the clot — are not eligible. Participants who have received fibrinolytics, clot-dissolving drugs, are excluded unless they still have a persistent moderate neurological deficit six or more hours after treatment. Standard of care therapies should not be withheld from participants considered for this trial.^[1]

What side effects are known?

The trial is designed to measure the incidence, severity and causality of adverse events and serious adverse events, including injection site reactions. No side effect data from completed studies are available in the registry record at this time.^[1]