Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
evinacumab · 6 trials · 4 indications
Cmax was obtained directly from the plasma concentration versus time curve.
AUClast was defined as area under the serum concentration time-curve from zero to the last measured concentration.
T1/2 was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.
Percent change was calculated as 100 multiplied by (calculated LDL-C value at Week 24 minus calculated LDL-C value at baseline) divided by calculated LDL-C value at baseline.
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Percent change was calculated as 100x(calculated LDL-C value at Week 24 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline. The baseline LDL-C value was the last calculated LDL-C value obtained before the first dose of double-blind-study drug. The calculated LDL-C at week 24 was the LDL-C value obtained within the week 24 efficacy analysis window, regardless of adherence to treatment and subsequent therapies (intent-to-treat \[ITT\] estimand). The ITT population included all randomized participants who received at least one dose or part of a dose of double-blind study drug. Participants in the ITT population were analyzed according to the treatment group allocated by randomization (i.e., as randomized participant group).
For participants randomized to evinacumab treatment group, baseline (Week 0) TG was defined as the geometric mean of all available TG results at day -28, day -14 and week 0; for participants randomized to placebo treatment group, baseline (Week 12) TG was defined as the geometric mean of all available TG results at weeks 6, 8, and 12.
| Arm | Type | Description |
|---|---|---|
| Evinacumab | EXPERIMENTAL | Part A: Single intravenous (IV) dose Part B: IV dose every 4 weeks (Q4W) until week 20 Part C: IV dose Q4W |
| Placebo | EXPERIMENTAL | - |
| Group A: dosing regimen 1 | EXPERIMENTAL | SC Evinacumab QW for 16 weeks |
| Group A: dosing regimen 2 | EXPERIMENTAL | SC Evinacumab Q2W for 16 weeks (alternating with matching placebo on opposite weeks) |
| Group A: dosing regimen 3 | EXPERIMENTAL | SC Evinacumab QW for 16 weeks |
| Group A: matching placebo | EXPERIMENTAL | Placebo SC QW for 16 weeks |
| Group B: dosing regimen 1 | EXPERIMENTAL | Intravenous (IV) Evinacumab Q4W for 24 weeks |
| Group B: dosing regimen 2 | EXPERIMENTAL | IV Evinacumab Q4W for 24 weeks |
| Group B: matching placebo | EXPERIMENTAL | Placebo IV Q4W for 24 weeks |
| Cohort 1 | EXPERIMENTAL | Evinacumab SC or placebo SC |
| Cohort 2 | EXPERIMENTAL | Low dose regimen: evinacumab IV or placebo IV |
| Cohort 3 | EXPERIMENTAL | High dose regimen: evinacumab IV or placebo IV |
| Cohort 4 | EXPERIMENTAL | Evinacumab or placebo SC every week (QW) x 8 doses |
| Cohort 5 | EXPERIMENTAL | Evinacumab or placebo SC x 1 dose |
| Name | Type | Description |
|---|---|---|
| Evinacumab | DRUG | Part A: Single IV dose Part B \& C: IV dose Q4W |
| Placebo | DRUG | IV administration of placebo |
| Matching placebo | DRUG | SC or IV administration |
| Background Lipid Modifying Therapy (LMT) | OTHER | All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit. |
Key Inclusion Criteria: 1. Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol 2. LDL-C \>130 mg/dL at the screening visit 3. Body weight ≥15 kg 4. Receiving stable maximally tolerated therapy\*at the screening visit \*Maximally tolerated therapy could inc...
Evinacumab is an investigational drug being studied for severe hypertriglyceridemia, hypercholesterolemia, and homozygous familial hypercholesterolemia. It has also been evaluated in healthy volunteers. Clinical trials have tested it in adults and pediatric patients with these lipid disorders.
Evinacumab targets ANGPTL3, a protein that regulates lipid metabolism. It acts as an inhibitor of this target, which is being studied for its potential to lower lipid levels in conditions like hypercholesterolemia and homozygous familial hypercholesterolemia.
Evinacumab is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The company has conducted multiple clinical trials to evaluate the drug's safety and efficacy.
Evinacumab has completed Phase 1, Phase 2, and Phase 3 clinical trials. It is an investigational drug and has not been reported as FDA approved. All completed trials include Phase 1 in healthy volunteers, Phase 2 in hypercholesterolemia, and Phase 3 in homozygous familial hypercholesterolemia.
Evinacumab has been studied in several completed trials, including NCT03146416 in healthy volunteers, NCT03175367 in hypercholesterolemia, NCT03399786 in homozygous familial hypercholesterolemia, and NCT04233918 in pediatric patients with homozygous familial hypercholesterolemia. These trials were conducted across multiple countries.
Yes, Evinacumab is also known as REGN1500. Clinical trial titles refer to it as Evinacumab (REGN1500), confirming that both names refer to the same investigational drug being developed by Regeneron Pharmaceuticals.