Approval Probability
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PRAM9 · 1 trial · 2 indications
The PD effects on plasma glucose levels were compared among the treatment arms as defined by AUC0-180 (mg/dL \* minutes) for plasma glucose \>180 mg/dL
| Arm | Type | Description |
|---|---|---|
| PRAM9 to Regular Insulin to Regular Insulin+pramlintide | EXPERIMENTAL | Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin (Humulin®) to Regular Insulin+pramlintide (Symlin® pen) as separate SC injections |
| Regular Insulin to Regular Insulin+pramlintide to PRAM9 | EXPERIMENTAL | Regular Insulin (Humulin®) to Regular Insulin+pamlintide (Symlin® pen) as separate SC injections to PRAM9 |
| Regular Insulin+pramlintide to PRAM9 to Regular Insulin | EXPERIMENTAL | Regular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin |
| PRAM9 to Regular Insulin+pramlintide to Regular Insulin | EXPERIMENTAL | Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Regular Insulin |
| Regular Insulin to PRAM9 to Regular Insulin+pramlintide | EXPERIMENTAL | Regular Insulin (Humulin®) to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin+pramlintide (Symlin® pen) as separate SC injections to Regular Insulin |
| Regular Insulin+pramlintide to Regular Insulin to PRAM9 | EXPERIMENTAL | Regular Insulin (Humulin®)+pramlintide (Symlin® pen) as separate SC injections to Xeris pramlintide + insulin co-formulation (PRAM9) to Regular Insulin to Xeris pramlintide + insulin co-formulation (PRAM9) |
| Name | Type | Description |
|---|---|---|
| PRAM9 | DRUG | SC injection |
| Regular Insulin + Pramlintide | DRUG | Separate SC injections |
| Regular Insulin | DRUG | SC injection |
Inclusion Criteria: 1. Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent 2. Male or non-pregnant, non-lactating female diagnosed with T1D for at least 24 months prior to Scre...
PRAM9 is an investigational small molecule being developed for the treatment of Type 1 Diabetes Mellitus. It is a novel pramlintide-insulin co-formulation intended to manage blood glucose levels in adults with insulin-dependent diabetes. The drug is currently in clinical development and has not been approved by regulatory authorities.
PRAM9 is being developed by Xeris Biopharma Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol XERS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Type 1 Diabetes Mellitus.
PRAM9 is in Phase 2 clinical development. It has completed a Phase 2 study, and it remains an investigational drug. As of the available data, PRAM9 has not received FDA approval and is still undergoing clinical evaluation for the treatment of Type 1 Diabetes Mellitus.
PRAM9 has been studied in one completed Phase 2 clinical trial with the identifier NCT04074317. This was a randomized, open-label, crossover pharmacodynamic and pharmacokinetic study of a novel pramlintide-insulin co-formulation in adults with Type 1 Diabetes Mellitus. The trial enrolled 18 participants in the United States.
PRAM9 is a co-formulation that combines pramlintide with insulin, but it is not the same as pramlintide alone. The drug is designed to deliver both components together to manage blood glucose in Type 1 Diabetes Mellitus. PRAM9 is an investigational product and is distinct from commercially available pramlintide.