Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ACP-001 (TransCon PEG hGH), ACP-001 (TransCon hGH)
ACP-001 · 2 trials · 2 indications
Number of subjects with positive results for anti-hGH binding antibodies at two consecutive post-dose visits
Number of subjects with positive results for anti-hGH neutralizing antibodies at two consecutive post-dose visits
Assessment of local tolerability was performed by examining injection sites (by the investigator during study visits) and on the basis of anamnestic data and records in the Patient Diary. Assessments included pain, redness, bruising, swelling, and itching. Every subject was counted only once within each symptom category.
As part of the following endpoint: PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the pharmacokinetic (PK) profile of hGH from the daily rhGH groups during visit 1 and 3. Uncorrected Cmax (maximum value of concentration) values at Visit 3 (Week 13)
As part of the following endpoint: PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the PK profile of hGH from the daily rhGH group during Visit 1 and Visit 3 Uncorrected AUC0-168h (area under the curve from 0h to 168h) values at Visit 3 (Week 13)
As part of the following endpoint: PD profile of serum IGF-1 during Visit 1 and Visit 3 compared between the ACP-001 dose groups and to the daily rhGH group Uncorrected E-Trough (the pre-dose efficacy response) values at Week 13
As part of the following endpoint: PD profile of serum IGF-1 during V1 and V3 compared between the ACP-001 dose groups and to the daily rhGH group
As part of the following endpoint: PD profile of serum IGF-1 during V1 and V3 compared between the ACP-001 dose groups and to the rhGH group. Uncorrected AUEC0-168 (area under the efficacy curve from 0h-168h) values at Week 13
Number of subjects with treatment emergent anti-hGH binding antibodies
| Arm | Type | Description |
|---|---|---|
| ACP-001, dose-level 1 | EXPERIMENTAL | Once weekly subcutaneous injection of ACP-001 |
| ACP-001, dose-level 2 | EXPERIMENTAL | Once weekly subcutaneous injection of ACP-001 |
| ACP-001, dose-level 3 | EXPERIMENTAL | Once weekly subcutaneous injection of ACP-001 |
| Human Growth Hormone | ACTIVE_COMPARATOR | Once daily subcutaneous injection of human Growth Hormone (rhGH) |
| ACP-001, 0.02 mg hGH/kg/wk | EXPERIMENTAL | Once weekly subcutaneous injection of ACP-001 equivalent to 0.02 mg hGH/kg/week for 4 weeks |
| ACP-001, 0.04 mg hGH/kg/wk | EXPERIMENTAL | Once weekly subcutaneous injection of ACP-001 equivalent to 0.04 mg hGH/kg/week for 4 weeks |
| ACP-001, 0.08 mg hGH/kg/wk | EXPERIMENTAL | Once weekly subcutaneous injection of ACP-001 equivalent to 0.08 mg hGH/kg/week for 4 weeks |
| Omnitrope, 0.04 mg hGH/kg/wk | ACTIVE_COMPARATOR | Once daily subcutaneous injection of human Growth Hormone (Omnitrope) equivalent to 0.04 mg hGH/kg/week for 4 weeks |
| Name | Type | Description |
|---|---|---|
| ACP-001 | DRUG | Once weekly subcutaneous injection |
| Human Growth Hormone | DRUG | Once daily subcutaneous injection of human Growth Hormone |
| ACP-001 (TransCon hGH) | DRUG | s.c., weekly injection |
| Omnitrope | DRUG | s.c., daily injection |
Inclusion Criteria: * Prepubertal children, Tanner stage 1 * Diagnosis of GHD, confirmed by two stimulation tests * Bone age not greater than chronological age * Impaired height and height velocity * BMI within +/- 2 SD (standard deviations) * Baseline IGF-1 (insulin-like growth factor) * Normal fu...
ACP-001 is an investigational long-acting human growth hormone therapy developed by Ascendis Pharma A/S for growth hormone deficiency. It is designed as a once-weekly treatment, in contrast to standard daily growth hormone injections. It has been studied in both children and adults with growth hormone deficiency.
ACP-001 is being developed to treat growth hormone deficiency in both children and adults. It is intended to replace daily human growth hormone injections with a once-weekly dosing schedule. The program has completed Phase 2 clinical testing in pediatric and adult growth hormone deficiency.
ACP-001 is being developed by Ascendis Pharma A/S, a biopharmaceutical company whose shares trade under the ticker ASND. Ascendis is responsible for the clinical development of the ACP-001 program in growth hormone deficiency.
ACP-001 is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. Two Phase 2 trials have been completed, one in children and one in adults with growth hormone deficiency.
ACP-001 has been evaluated in two completed Phase 2 trials. NCT01947907 compared weekly ACP-001 with daily human growth hormone in 53 children with growth hormone deficiency across multiple countries. NCT01247675 studied the safety, pharmacokinetics, and pharmacodynamics of ACP-001 in 37 adults with growth hormone deficiency in Europe.
Yes, ACP-001 is also known as TransCon PEG hGH and TransCon hGH. These names refer to the same investigational long-acting growth hormone product developed by Ascendis Pharma A/S. The TransCon designation reflects the company's sustained-release technology platform used in the product.