Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MOD-4023 (long lasting hGH), Somatrogon
MOD-4023 · 7 trials · 5 indications
Annual Height Velocity in cm/year after 12 months of treatment.
Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.
Annualized Height Velocity (cm/year) in OLE Phase
A summary of the annualized HV at the end of each year for Periods III/IV (OLE Years 1 - 4) and V (PEN Years 1 - 5).
A summary of annual change in height SDS at the end of each year for Periods III/IV (OLE Years 1 - 4) and V (PEN Years 1 - 5). Height SDS (Standard Deviation Score) reflects how an individual's height compares to the average for their age and sex, calculated using Growth Analyzer and based on Switzerland 1989 (Prader) reference. A z-score of 0 indicates a height equal to the population mean, while positive scores indicate above-average heights and negative scores reflect below-average heights.
Annual Height Velocity in cm/year measured after 12 months of treatment
Adverse events (AE's), vital signs, electrocardiogram (ECG), laboratory tests, local reaction
The primary efficacy endpoint will be the mean time interval of IGF-I levels that lay within ±1.5 SDS after the last dose administration during stage I (4w treatment) expressed in hours.
To assess the safety, tolerability and immunogenicity of MOD-4023 in healthy Caucasian and Japanese subjects after single subcutaneous (SC) dose.
MOD-4023 serum levels (T1/2, Area-Under-the-Curve, Cmax, Tmax)
| Arm | Type | Description |
|---|---|---|
| MOD-4023 Treatment Arm | EXPERIMENTAL | MOD-4023 (investigational treatment): weekly MOD-4023 SC injections for 12 months; initially over the first 6 weeks, MOD-4023 will be administered in 3 stepwise escalating doses (0.25 mg/kg/week, 0.48 mg/kg/week and 0.66 mg/kg/week), each for two weeks sequentially. For the remaining 46 weeks, patients will continue to receive MOD-4023 at a dose of 0.66 mg/kg/week. |
| Genotropin Treatment Arm | ACTIVE_COMPARATOR | Genotropin® (reference treatment): daily Genotropin® (0.025 mg/kg/day). |
| MOD-4023 | EXPERIMENTAL | Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) |
| Genotropin | ACTIVE_COMPARATOR | Once daily subcutaneous injection of somatropin (r-hGH; Genotropin) |
| MOD-4023 low dose | EXPERIMENTAL | Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) |
| MOD-4023 middle dose | EXPERIMENTAL | Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) |
| MOD-4023 high dose | EXPERIMENTAL | Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) |
| Weekly low dose | EXPERIMENTAL | MOD-4023 |
| Weekly middle dose | EXPERIMENTAL | MOD-4023 |
| Weekly high dose | EXPERIMENTAL | MOD-4023 |
| Every-other week dose | EXPERIMENTAL | MOD-4023 |
| Somatrogon pre-filled PEN | EXPERIMENTAL | - |
| Somatrogon frozen liquid formulation | ACTIVE_COMPARATOR | - |
| Low dose | EXPERIMENTAL | 7 Japanese and 7 Caucasian subjects (randomized 6:1) administered a single dose of MOD-4023/Placebo |
| Mid dose | EXPERIMENTAL | 7 Japanese and 7 Caucasian subjects (randomized 6:1) administered a single dose of MOD-4023/Placebo |
| High dose | EXPERIMENTAL | 7 Japanese and 7 Caucasian subjects (randomized 6:1) administered a single dose of MOD-4023/Placebo |
| Name | Type | Description |
|---|---|---|
| MOD-4023 | DRUG | MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN. MOD-4023 will be administered as a SC injection once weekly, using a delivery device. |
| Genotropin | DRUG | Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections. A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated. Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week). |
| Somatropin | DRUG | Once daily subcutaneous injection of Genotropin using pre-filled pen device. |
| Somatrogon | DRUG | A single dose of 12 mg of somatrogon will be injected as one sc injection to the arm on each dosing day (Day 0 and Day 14). |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Pre-pubertal child aged ≥ 3 years old, and not yet 10 years for girls (9 years and 364 days) or not yet 11 years for boys (10 years and 364 days), on the date of ICF signature, with either isolated GHD, or GH insufficiency as part of multiple pituitary hormone deficiency. 2. ...
MOD-4023 is an investigational long-acting human growth hormone (hGH) therapy being developed by OPKO Health Inc. (NASDAQ: OPK) for growth hormone deficiency. It is designed to reduce the frequency of injections compared with daily growth hormone therapy. It is currently in Phase 2 development.
MOD-4023 is being developed for the treatment of growth hormone deficiency in adults and children. It is intended to replace endogenous growth hormone in patients who do not produce enough. The drug is investigational and has not been approved for any indication.
MOD-4023 targets the growth hormone receptor (GHR). By binding to this receptor, it mimics the action of endogenous growth hormone, stimulating growth and metabolic effects. The target is a cell surface receptor, and the drug is a long-acting form of human growth hormone.
MOD-4023 is being developed by OPKO Health Inc., a biopharmaceutical company traded on the NASDAQ under the ticker OPK. OPKO has conducted clinical trials of MOD-4023 in both adult and pediatric growth hormone deficiency.
MOD-4023 is in Phase 2 development. It has completed Phase 1, Phase 2, and Phase 3 clinical trials, but the overall development program is currently at Phase 2. It is investigational and has not been approved by the FDA or any other regulatory agency.
MOD-4023 has been studied in several completed clinical trials, including NCT03874013 (Phase 3 in Japan), NCT02968004 (Phase 3 global pediatric study), NCT02500316 (Phase 2 long-term follow-up), and NCT02418767 (Phase 1 pharmacokinetics in healthy volunteers). All trials are listed as completed.
MOD-4023 is also known as long-acting hGH (long-lasting human growth hormone). This alternative name reflects its extended duration of action compared with daily growth hormone injections. It is the same investigational product developed by OPKO Health.