Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DM199 · 3 trials · 6 indications
Incidence, severity, and causality of adverse events
eGFR
UACR change from baseline
Maximum plasma concentration of DM199
urine KLK1 will be measured pre and post study drug administration.
Number of participants with adverse events in the single and multiple ascending dose studies.
Determine the plasma pharmacokinetic profile of DM199 after administration of single and multiple doses of DM199 in healthy subjects and type 2 diabetes mellitus patients. Measure plasma DM199 levels in individual participants.
| Arm | Type | Description |
|---|---|---|
| 2.0 µg/kg, multiple dose | EXPERIMENTAL | n=45 with 15 Participants from cohort 1, 15 from cohort 2, and 15 from cohort 3 |
| 5.0 µg/kg, multiple dose | EXPERIMENTAL | n=45 with 15 Participants from cohort 1, 15 from cohort 2 and 15 from cohort 3 |
| 3.0 µg/kg SC, single dose | EXPERIMENTAL | n=8, study group of T1D or T2D with stage 3 CKD. separate n=8 of study group with T1D or T2D with CKD stage 4). |
| 5.0 µg/kg SC, single dose | EXPERIMENTAL | n=8, study group of T1D or T2D with stage 3 CKD. |
| 8.0 µg/kg SC, single dose | EXPERIMENTAL | n=8, study group of T1D or T2D with stage 3 CKD. |
| Part A - SAD in healthy subjects | EXPERIMENTAL | A randomized, double-blinded, placebo-controlled, single ascending dose (SAD) study in healthy male and/or female subjects. Subjects will receive DM199 subcutaneously (sc). |
| Part B - SAD in type 2 diabetic patients | EXPERIMENTAL | A randomized, partially double-blinded, placebo-controlled, sequential SAD study in male and/or female type 2 diabetes mellitus patients. Subjects will receive DM199 subcutaneously (sc). |
| Part C - MAD in healthy subjects | EXPERIMENTAL | A randomized, double-blinded, placebo-controlled, 14-day multiple ascending dose (MAD) study in healthy male and/or female subjects each. Subjects will receive sequential doses of DM199 sc for 14 days. |
| Part D - POC in type 2 diabetes patients | EXPERIMENTAL | A randomized, double-blinded, placebo-controlled, 28-day multiple-dose proof of concept (POC) study in male and/or female type 2 diabetes mellitus patients. Subjects will receive doses of DM199 sc for 28 days. |
| Part A - Healthy subjects SAD placebo | PLACEBO_COMPARATOR | A randomized, double-blinded, placebo-controlled, single ascending dose (SAD) study in healthy male and/or female subjects. Subjects will receive placebo subcutaneously (sc). |
| Part B - Type 2 diabetic patients SAD placebo | PLACEBO_COMPARATOR | A randomized, partially double-blinded, placebo-controlled, sequential SAD study in male and/or female type 2 diabetes mellitus patients. Subjects will receive placebo subcutaneously (sc). |
| Part C - Healthy subjects MAD placebo | PLACEBO_COMPARATOR | A randomized, double-blinded, placebo-controlled, 14-day multiple ascending dose (MAD) study in healthy male and/or female subjects each. Subjects will receive placebo sc for 14 days. |
| Part D - Type 2 diabetic patients POC placebo | PLACEBO_COMPARATOR | A randomized, double-blinded, placebo-controlled, 28-day multiple-dose proof of concept (POC) study in male and/or female type 2 diabetes mellitus patients. Subjects will receive placebo sc for 28 days. |
| Name | Type | Description |
|---|---|---|
| DM199 | DRUG | A pharmaceutical formulation comprised of recombinant human tissue kallikrein-1 (rhKLK-1) that is being developed as an injectable protein drug |
| Placebo | DRUG | - |
Inclusion Criteria: Cohort I * African American * Hypertension as defined by the American Heart Association for Stage I hypertension where systolic blood pressure (BP) ≥130 mmHg or diastolic BP ≥ 80 mmHg or on medication for treatment of hypertension. Cohort II * IgA nephropathy confirmed by med...
DM199 is an investigational small molecule being studied for kidney diseases, chronic kidney disease, and type 2 diabetes. It has been evaluated in clinical trials involving healthy subjects and patients with type 2 diabetes, chronic kidney disease stages 3 and 4, and other kidney diseases.
DM199 is being developed by DiaMedica Therapeutics Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol DMAC.
DM199 is in clinical development. It has completed Phase 1 and Phase 2 trials. The most advanced completed trial was a Phase 2 study in patients with chronic kidney disease. DM199 is not approved and remains investigational.
DM199 has been studied in three completed clinical trials. NCT01845064 evaluated safety and effectiveness in healthy subjects and type 2 diabetes patients. NCT03795389 assessed pharmacokinetics, safety, and tolerability in patients with diabetes and chronic kidney disease. NCT04123613, the REDUX study, tested multiple doses in patients with kidney diseases.
No alternative names for DM199 have been identified. The drug is consistently referred to as DM199 across its clinical trials and development program.