Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MOD-4023
Somatrogon · 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. ...
Somatrogon is an investigational small molecule developed by Opko Health Inc. (ticker OPK). It is a growth hormone receptor agonist that has been studied in a Phase 1 clinical trial in healthy male volunteers. The specific therapeutic indication for somatrogon has not been publicly disclosed.
Somatrogon targets the growth hormone receptor (GHR) and acts as an agonist at that receptor. By binding and activating GHR, it is designed to stimulate growth hormone receptor signaling. This mechanism underlies its investigation as a growth hormone receptor agonist in clinical development.
Somatrogon is being developed by Opko Health Inc., which trades under the ticker symbol OPK. Opko Health sponsored the Phase 1 clinical study of somatrogon conducted in the United States. No other development partners are identified for this asset.
Somatrogon is in Phase 1 clinical development. It is an investigational drug and is not approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for somatrogon.
Somatrogon has been evaluated in one completed Phase 1 trial, NCT03810664, titled a clinical study investigating the comparability of somatrogon in two different drug product presentations. The trial enrolled 49 healthy male volunteers aged 18 years and older in the United States and used an active-controlled, randomized design.