Drugs / mRNA-3927
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05130437 | Nov 2021 → Dec 2029 expected | propionic acidemia | ModernaTX, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04159103 | Apr 2021 → Aug 2027 expected | propionic acidemia | ModernaTX, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-09-12 | ModernaTX, Inc. | Results Moderna R&D Day Highlights Progress and Strategic Priorities q4web.com ↗
Early results suggest potential decreases in annualized MDE frequency compared to pre-treatment, and the majority of patients have elected to continue on the open label extension study. |
| 2024-04-03 | ModernaTX, Inc. | Results Phase 1/2 Interim Data on Moderna’s mRNA-3927, an Investigational mRNA Therapy for Propionic Acidemia, Published in Nature q4web.com ↗
These interim data indicate early signs of potential clinical benefit with mRNA-3927, and importantly also demonstrate that mRNA-3927 has infrequent treatment-limiting side effects. |
| 2023-05-19 | ModernaTX, Inc. | Results Phase 1/2 Interim Data on Moderna's mRNA-3927, an Investigational mRNA Therapy for Propionic Acidemia (PA), Presented at the 2023 ASGCT Annual Meeting q4web.com ↗
To date, mRNA-3927 has been generally well-tolerated at the doses administered, with encouraging early signs of dose-dependent pharmacology and potential clinical benefits |
| 2022-09-08 | ModernaTX, Inc. | Results Moderna Reviews Clinical Trial Programs Across Portfolio at 2022 R&D Day q4web.com ↗
Interim data from Phase 1/2 propionic acidemia (PA) multi-dose Paramount trial shows mRNA-3927 was well-tolerated to date, with encouraging early signs of potential for clinical benefit |
| 2019-10-22 | ModernaTX, Inc. | Regulatory Moderna Receives FDA Fast Track Designation for Propionic Acidemia Program (mRNA-3927) q4web.com ↗
Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for mRNA-3927, its investigational mRNA therapeutic for propionic acidemia (PA). |
| 2019-09-30 | ModernaTX, Inc. | Regulatory Moderna Announces Open IND for Propionic Acidemia Program (mRNA-3927) q4web.com ↗
mRNA-3927 is Moderna’s second rare disease program with an open IND |
| 2019-01-08 | ModernaTX, Inc. | Regulatory Moderna Announces Recent Progress in Its Immuno-Oncology and Rare Disease Programs and Highlights Corporate Objectives q4web.com ↗
mRNA-3927 was granted Orphan Drug Designation by the FDA in December 2018 and Rare Pediatric Disease Designation by the FDA in January 2019. |
All press releases naming this drug 9 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mRNA-3927 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05130437 ↗ |
| Modality | Messenger RNA (mRNA) | “An enzyme replacement therapy is being developed using dual messenger RNA (mRNA) therapy composed of lipid nanoparticles (LNPs) encapsulating mRNAs encoding PCCA and PCCB...” PMID 36577040 ↗ Dec 2022 |
| Route | Intravenous | “by intravenous (IV) infusion” NCT04159103 ↗ |
| Target | PCCA | “mRNAs encoding PCCA and PCCB subunits of the PCC enzyme” PMID 36577040 ↗ Dec 2022 |
| Target | PCCB | “mRNAs encoding PCCA and PCCB subunits of the PCC enzyme” PMID 36577040 ↗ Dec 2022 |