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MOD-5014 · 2 trials · 3 indications
To assess the acute safety and tolerability of single intravenous (IV) administration of escalating MOD-5014 doses in hemophilic subjects with and without inhibitors.
| Arm | Type | Description |
|---|---|---|
| MOD-5014 | EXPERIMENTAL | MOD-5014 longevity is the result of fusion of three consecutive C-terminal peptide (CTP) domains to the C-terminus of FVII. CTP technology is based on a natural peptide, the C-terminal peptide of the beta chain of human chorionic gonadotropin (hCG), which provides hCG with the required longevity to maintain pregnancy (initial half-life \[t1/2\] \~10 h, terminal t1/2 \~37 h). The beta chain of luteinizing hormone (LH), a gonadotropin that triggers ovulation, is almost identical to hCG but does not include the CTP. As a result, LH has a significantly shorter half-life in blood (initial t1/2 \~1 h, terminal t1/2 \~10 h) (Fares et al., 1992). |
| MOD-5014 Placebo | PLACEBO_COMPARATOR | Placebo solution for SC injection containing the same inactive ingredients used in the active drug product at matching volumes |
| Dose Cohort 1 | EXPERIMENTAL | Lowest MOD-5014 dose tested in the study |
| Dose Cohort 2 | EXPERIMENTAL | MOD-5014 Dose cohort 2 |
| Dose Cohort 3 | EXPERIMENTAL | MOD-5014 Dose cohort 3 |
| Dose Cohort 4 | EXPERIMENTAL | MOD-5014 Dose cohort 4 |
| Dose Cohort 5 | EXPERIMENTAL | MOD-5014 Dose cohort 5 |
| Dose Cohort 6 | EXPERIMENTAL | Highest MOD-5014 dose tested in the study |
| Name | Type | Description |
|---|---|---|
| MOD-5014 | BIOLOGICAL | MOD-5014, a long-acting modified recombinant Factor VIIa |
| MOD-5014 Placebo | OTHER | Placebo solution for SC injection containing the same inactive ingredients used in the active drug product at matching volumes |
Inclusion Criteria: 1. Men, 18-50 years of age, inclusive, at the screening visit. 2. Subjects must provide written informed consent prior to participating in the study. 3. Considered healthy based on medical history, physical examination and clinical laboratory results. 4. Body Mass Index (BMI) 19...
MOD-5014 is an investigational small molecule being developed for hemophilia A and hemophilia A or B with inhibitors. It is a long-acting factor VIIa product studied in adult men with these bleeding disorders. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
MOD-5014 is being developed by Opko Health Inc., a biopharmaceutical company traded on the NASDAQ under the ticker OPK. The company is conducting Phase 1 clinical trials to evaluate the safety and tolerability of this investigational therapy for hemophilia A and hemophilia B with inhibitors.
MOD-5014 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in healthy volunteers and one in adult men with hemophilia A or B. The drug remains investigational and has not received FDA approval or any other regulatory approval.
MOD-5014 has been studied in two completed Phase 1 trials. NCT02418793 evaluated a long-acting recombinant factor VIIa in 27 adult men with hemophilia A or B in the United States. NCT02919800 was a single-dose, dose-escalation study in 32 healthy adult males in Israel, focusing on hemophilia A or B with inhibitors.
MOD-5014 is a long-acting recombinant factor VIIa product. It works by replacing or supplementing factor VIIa, a protein that helps blood clot, to restore hemostasis in patients with hemophilia who have inhibitors. This mechanism is intended to bypass the need for factor VIII or IX, which are deficient or inhibited in these patients.
MOD-5014 is a long-acting recombinant factor VIIa product. It is designed to have an extended half-life compared to standard factor VIIa, potentially allowing less frequent dosing. The clinical trials for MOD-5014 specifically evaluate its long-acting properties in patients with hemophilia A or B with inhibitors.