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MGTA-456

Phase 2

Inherited Metabolic Disorders (IMD) | Small molecule | Rare Disease |Dianthus Therapeutics, Inc.|Last Updated: Nov 3, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

MGTA-456 · 1 trial · 1 indication

Phase 2 1
NCT03406962MGTA-456 in Patients With Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplantation (HSCT)Inherited Metabolic Disorders (IMD)
COMPLETED8 Analytics
PHASE2COMPLETED
MGTA-456 in Patients With Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Inherited Metabolic Disorders (IMD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Engraftment
42 days

Engraftment is defined as achieving an absolute neutrophil count (ANC) ≥0.5 × 10⁹/L for 3 consecutive days.

Secondary Endpoints

Number of Participants With Infusion Toxicities
48 hours
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MGTA-456EXPERIMENTALMGTA-456 is an expanded CD34+ cell therapy investigational product used in replacement of single umbilical cord blood transplantation.

Interventions

NameTypeDescription
MGTA-456DRUGHematopoietic stem cell transplantation will be done with the cell therapy product MGTA-456.
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Eligibility Criteria

Age Range0 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Age \< 2.5 years with Hurler syndrome, age 2-17 years with cerebral adrenoleukodystrophy (cALD), age \< 16 years with metachromatic leukodystrophy (MLD) and age ≤ 10 years with globoid cell leukodystrophy (GLD) (also referred to as Krabbe) * Cord blood grafts require genetic t...

Countries:United States
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Frequently asked questions about MGTA-456

What is MGTA-456 used for?

MGTA-456 is an investigational small molecule being studied for the treatment of inherited metabolic disorders (IMD). It is designed for patients undergoing hematopoietic stem cell transplantation (HSCT). The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does MGTA-456 target?

MGTA-456 is a small molecule, but its specific molecular target has not been disclosed. It is being investigated for its potential role in improving outcomes for patients with inherited metabolic disorders undergoing hematopoietic stem cell transplantation.

Who is developing MGTA-456?

MGTA-456 is being developed by Dianthus Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol DNTH. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with inherited metabolic disorders.

What phase is MGTA-456 in?

MGTA-456 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of inherited metabolic disorders in patients undergoing hematopoietic stem cell transplantation.

What clinical trials is MGTA-456 in?

MGTA-456 has been studied in a Phase 2 clinical trial with the identifier NCT03406962. This trial, titled 'MGTA-456 in Patients With Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplantation (HSCT),' was completed and enrolled 8 participants in the United States. The trial was uncontrolled and not blinded.

Is MGTA-456 the same as any other drug?

MGTA-456 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is being developed by Dianthus Therapeutics, Inc. for the treatment of inherited metabolic disorders.