Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Recombinant human tissue kallikrein · 3 trials · 4 indications
Stroke recovery as defined by participants with excellent functional outcomes at Day 90 as assessed via the Modified Rankin Score (mRS \[dichotomized\]), mRS scores of 0 or 1 represent responders, scale range of 0-6. The mRS (Modified Rankin Scale) is a single-item, clinician-reported measure of functional disability in participants with AIS. Scores range in grade from 0 (no symptoms at all) to 6 (participant death).
Assessed by total number and severity of all treatment-related adverse events.
Assessment of safety of intravenous dosing
| Arm | Type | Description |
|---|---|---|
| DM199 | EXPERIMENTAL | DM199 administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21. |
| Placebo for DM199 Solution for Injection | PLACEBO_COMPARATOR | Placebo administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21. |
| Recombinant human tissue kallikrein | EXPERIMENTAL | A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours. |
| Placebo | PLACEBO_COMPARATOR | A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours. |
| Low dose (Part A) | EXPERIMENTAL | Recombinant human tissue kallikrein |
| Medium low dose (Part A) | EXPERIMENTAL | Recombinant human tissue kallikrein |
| Medium high dose (Part A) | EXPERIMENTAL | Recombinant human tissue kallikrein |
| High dose (Part A) | EXPERIMENTAL | Recombinant human tissue kallikrein |
| Subcutaneous (Part B) | EXPERIMENTAL | Recombinant human tissue kallikrein |
| IV (Part B) | EXPERIMENTAL | Recombinant human tissue kallikrein |
| Name | Type | Description |
|---|---|---|
| Recombinant human tissue kallikrein | DRUG | DM199 administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21 |
| Placebo for DM199 Solution for Injection | OTHER | Placebo administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21. |
| Placebo | OTHER | Placebo Comparator: Phosphate buffered saline |
Inclusion Criteria: 1. Participant is between 18 and 90 years of age inclusive. 2. Participant weight is 40 kg to 166 kg inclusive. 3. Participant to be randomized and treatment initiated within 24 hours of last known normal/AIS stroke onset. 4. Participant has NIHSS ≥5 and ≤15 at approximately the...
Recombinant human tissue kallikrein is an investigational drug being developed for acute ischemic stroke and acute stroke. It is a small molecule exogenous protein being studied in patients who have experienced a stroke, with clinical trials evaluating its safety and tolerability in this patient population.
Recombinant human tissue kallikrein targets the F9 gene product, which is factor IX, a protein involved in blood coagulation. As an exogenous protein, it is administered to modulate this target in the context of acute ischemic stroke treatment.
DiaMedica Therapeutics Inc. (NASDAQ: DMAC) is developing Recombinant human tissue kallikrein. The company is conducting clinical trials of this drug candidate for the treatment of acute ischemic stroke and other stroke-related conditions.
Recombinant human tissue kallikrein is currently in Phase 2 clinical development. It is an investigational drug that has not been approved by regulatory authorities, and it remains under evaluation in clinical trials for acute ischemic stroke.
Recombinant human tissue kallikrein has been studied in three clinical trials: NCT02868996, a Phase 1b ascending dose study in healthy volunteers with stroke; NCT03290560, a Phase 2 safety and tolerability study in acute ischemic stroke patients; and NCT05065216, the Phase 2 ReMEDy2 trial currently recruiting patients with acute stroke.
Yes, Recombinant human tissue kallikrein is also known as DM199. Clinical trials such as NCT02868996 and NCT03290560 refer to the drug as DM199, and the ongoing ReMEDy2 trial (NCT05065216) evaluates this same drug candidate for acute ischemic stroke.