Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Remlarsen
MRG-201 · 2 trials · 2 indications
The percentage of subjects with confirmed keloid formation at treated versus untreated lesions at 24 weeks (± 7 days) after first dose, analyzed using the modified Vancouver Scar Scale which reports a cumulative score based on subscores for vascularity, pliability and height.
| Arm | Type | Description |
|---|---|---|
| Remlarsen - Intradermal | EXPERIMENTAL | Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject will serve as their own simultaneous control. |
| Placebo - Intradermal | PLACEBO_COMPARATOR | Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject will serve as their own simultaneous control. |
| MRG-201 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Remlarsen | DRUG | Intradermal injection at site of one excisional wound |
| Placebo | DRUG | Intradermal injection at site of second excisional wound |
| MRG-201 | DRUG | Intradermal injection of single ascending doses and multiple ascending doses in healthy volunteers. |
Key Inclusion Criteria: * Must provide written informed consent. * Females must not be pregnant, or lactating, and have negative pregnancy tests. * Study candidates should be likely to form keloids in the upper back/shoulder area after punch biopsy based on a history of a high frequency of keloid f...
MRG-201 is an investigational small molecule therapeutic being developed by CASI Pharmaceuticals, Inc. (ticker: CASI). It has been studied in a Phase 1 clinical trial in healthy volunteers. The specific disease indications for which MRG-201 is being developed have not been publicly disclosed.
MRG-201 is being developed by CASI Pharmaceuticals, Inc., which trades under the ticker symbol CASI. The company is the sponsor of the clinical program for this investigational small molecule asset.
MRG-201 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA for any indication.
MRG-201 has been evaluated in one completed Phase 1 trial, NCT02603224, titled Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy Volunteers. The trial enrolled 54 male participants aged 18 years and older in Canada and was randomized, double-blind, and placebo-controlled.