drugset

Drugs / mRNA-3704

Follow last change Aug 2020 re-read 3 minutes ago

mRNA-3704

Messenger RNA (mRNA)

Developed for: methylmalonic aciduria due to methylmalonyl-CoA mutase deficiency
Investigated by: ModernaTX, Inc.

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed	US (FDA)	—	methylmalonic acidemia	2019-01-08	“IND submitted to the FDA for a Phase 1/2 study of methylmalonic acidemia (mRNA-3704)” q4web.com ↗

Trials 1

today NCT03810690 · Ph 1/2

2020202120222023202420252026

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 1/2	NCT03810690	May 2019 → Aug 2020	methylmalonic aciduria due to methylmalonyl-CoA mutase deficiency	ModernaTX, Inc.	Withdrawn	No outcome recorded Stop: Business

News releases announcing trial results or a regulatory action · 3

Date	Issuer	Release
2019-03-06	ModernaTX, Inc.	Regulatory Moderna Reports 2018 Fourth Quarter and Full Year Financial Results and Highlights Recent Pipeline Progress q4web.com ↗ FDA grants Fast Track designation for methylmalonic acidemia (MMA) program (mRNA-3704)
2019-01-08	ModernaTX, Inc.	Regulatory Moderna Announces Recent Progress in Its Immuno-Oncology and Rare Disease Programs and Highlights Corporate Objectives q4web.com ↗ IND submitted to the FDA for a Phase 1/2 study of methylmalonic acidemia (mRNA-3704)
2017-12-19	ModernaTX, Inc.	Results Moderna Publishes Preclinical Data in Cell Reports on mRNA Therapeutic to Treat Rare Liver Disease Methylmalonic Acidemia (MMA), A Disorder of Organic Acid Metabolism modernatx.com ↗ Repeat IV dosing did not increase markers of liver toxicity or inflammation.

All press releases naming this drug 4 releases

Date	Issuer	Release
2020-02-10	ModernaTX, Inc.	Moderna Announces First Patient Enrolled in Phase 1/2 Study of mRNA-3704 for Methylmalonic Acidemia q4web.com ↗
2019-03-06	ModernaTX, Inc.	Moderna Reports 2018 Fourth Quarter and Full Year Financial Results and Highlights Recent Pipeline Progress q4web.com ↗
2019-01-08	ModernaTX, Inc.	Moderna Announces Recent Progress in Its Immuno-Oncology and Rare Disease Programs and Highlights Corporate Objectives q4web.com ↗
2017-12-19	ModernaTX, Inc.	Moderna Publishes Preclinical Data in Cell Reports on mRNA Therapeutic to Treat Rare Liver Disease Methylmalonic Acidemia (MMA), A Disorder of Organic Acid Metabolism modernatx.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

Field	Value	Cited text
Known as	mRNA-3704	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03810690 ↗
Modality	Messenger RNA (mRNA)	“mRNA-3704 dispersion” NCT03810690 ↗
Route	Intravenous	“intravenous (IV) infusion” NCT03810690 ↗