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mRNA-3927 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| mRNA-3927 | EXPERIMENTAL | Participants will receive the applicable dose identified during Study mRNA-3927-P101 (NCT04159103) on Day 1. The dose can be adjusted based on Sponsor recommendation. |
| Part 1 (Dose Optimization), Part 2 (Pivotal Study), and Part 3 (Infants) | EXPERIMENTAL | Part 1 (Dose Optimization): Participants (≥1 year of age) will receive single dose of mRNA-3927 by intravenous (IV) infusion every 2 weeks (Q2W) or every 3 weeks (Q3W) for up to 10 doses. Part 2 (Pivotal Study): Participants (≥1 year of age) will receive single dose of mRNA-3927 (identified during Dose Optimization Phase) by IV infusion Q2W for up to 26 doses or approximately 12 months. Part 3: Participants (\<1 year of age) will receive single dose of mRNA-3927 (identified during Dose Optimization Phase) by IV infusion Q2W for up to 26 doses or approximately 12 months. |
| Name | Type | Description |
|---|---|---|
| mRNA-3927 | BIOLOGICAL | mRNA-3927 dispersion for IV infusion |
Inclusion Criteria: * Participated in Study mRNA-3927-P101. * Completed the EOT/ET visit in Study mRNA-3927-P101 and enroll in this study such that the first dose in this study is planned to be within 14±3 days of the last dose of mRNA-3927 in the mRNA-3927-P101 study. Exclusion Criteria: * Not e...
mRNA-3927 is an investigational RNA therapy being developed for the treatment of propionic acidemia, a rare inherited metabolic disorder. It is designed as a disease-modifying approach for patients with this condition. The therapy is currently in Phase 1 clinical development and has not been approved for any indication.
mRNA-3927 is being developed by Moderna, Inc., which trades on the Nasdaq under the ticker symbol MRNA. Moderna is the sponsor of the clinical program evaluating the therapy in patients with propionic acidemia.
mRNA-3927 is in Phase 1 clinical development. Two Phase 1 trials are currently recruiting participants, and no trials have been completed. The program remains investigational, and the therapy has not received regulatory approval for any indication.
mRNA-3927 is being evaluated in two Phase 1 trials: NCT04159103, an open-label study in participants with propionic acidemia, and NCT05130437, a long-term safety and clinical activity study for participants previously enrolled in the mRNA-3927-P101 study. Both trials are recruiting and together plan to enroll 127 participants across the United States, Canada, France, Japan, Netherlands, Saudi Arabia, Spain, and the United Kingdom.
No, mRNA-3927 is not FDA approved. It is an investigational therapy in Phase 1 clinical development for propionic acidemia. Both of its clinical trials are currently recruiting, and no trials have been completed, so the therapy remains under study and is not available as an approved treatment.