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Firibastat · 4 trials · 5 indications
Automatic Office Blood Pressure measurement
Comparison of the effects of BID oral administration of 2 doses of firibastat to those of BID oral administration of ramipril on the change from Baseline in LVEF on Day 84
The plasma concentration data for firibastat (QGC001), EC33 and QGC515, will be analysed at each time measurement (predose, 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose)
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\[AUC0-24, AUC0-last and AUC0-inf\]
| Arm | Type | Description |
|---|---|---|
| Firibastat | EXPERIMENTAL | Capsules |
| Placebo | PLACEBO_COMPARATOR | Matching capsules |
| Group 1: firibastat 100 mg | EXPERIMENTAL | Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks. |
| Group 2: firibastat 500 mg | EXPERIMENTAL | Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks. |
| Group 3: ramipril 5 mg | ACTIVE_COMPARATOR | Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks. |
| Treatment | EXPERIMENTAL | 500 mg (2 capsules of 250 mg) |
| Firibastat prototype tablet formulations | EXPERIMENTAL | Firibastat (QGC001) 500 mg modified release prototype tablet formulations or immediate release capsule formulation - 1 tablet or 1 capsule administered per period |
| Name | Type | Description |
|---|---|---|
| Firibastat | DRUG | Oral administration 2×250 mg capsules bid |
| Placebo | DRUG | Oral administration 2 capsules bid |
| Ramipril | DRUG | 1 or 2 capsules administered orally, twice daily |
Inclusion Criteria: * Men and women ≥18 years of age at Screening * Diagnosis of primary HTN for at least 6 months prior to Screening Exclusion Criteria: * Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease). * Automated office SBP \>18...
Firibastat is an investigational small molecule being studied for use in myocardial infarction and hypertension. Clinical trials have evaluated it in patients after acute myocardial infarction for prevention of left ventricular dysfunction, and in patients with treatment-resistant hypertension. It has also been studied in healthy volunteers and healthy males for pharmacokinetic purposes.
Firibastat is being developed by Quantum Biopharma Ltd., a company traded under the ticker QNTM. The drug is currently in clinical development, with trials completed across multiple phases.
Firibastat has completed clinical trials in Phase 1, Phase 2, and Phase 3. The Phase 3 trial evaluated the drug in treatment-resistant hypertension, while Phase 2 studied it after acute myocardial infarction, and Phase 1 trials assessed pharmacokinetics in healthy volunteers and patients with renal failure.
Firibastat has been studied in four completed clinical trials. NCT03714685 evaluated prototype tablet formulations in healthy males. NCT03715998 studied Firibastat or ramipril after acute myocardial infarction. NCT04277884 assessed Firibastat in treatment-resistant hypertension, and NCT04792333 examined pharmacokinetics in end stage renal disease patients.
No, Firibastat is not the same as ramipril. In one clinical trial, NCT03715998, Firibastat was compared against ramipril after acute myocardial infarction. The two drugs were studied as separate treatment arms in that trial.
Yes, Firibastat has been studied in patients with kidney disease. A Phase 1 trial, NCT04792333, evaluated the pharmacokinetics of Firibastat in patients with end stage renal disease. This trial enrolled 28 participants and was conducted in France.