M281

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

4 competitors in Warm Autoimmune Hemolytic Anemia

#DrugCompanyPhaseTrials

1

Wayrilz

GGenzyme, a Sanofi Company

Phase 3

12

Obexelimab

ZZenas BioPharma (USA), LLC

Phase 3

13

M281

MMomenta Pharmaceuticals, Inc.

Phase 3

14

Fabhalta

Johnson & Johnson

Preclinical

15

OM336

OOuro Medicines

Phase 1

1

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Myasthenia Gravis2 trials

An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis

Terminated·MMomenta Pharmaceuticals, Inc.·Phase 2·NCT03896295·37 enrolled

A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis

Completed·MMomenta Pharmaceuticals, Inc.·Phase 2·NCT03772587·68 enrolled

Tics1 trial

An Ascending Dose Study to Evaluate M281 Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)

Completed·MMomenta Pharmaceuticals, Inc.·Phase 1·NCT02828046·50 enrolled

Pregnant Women1 trial

A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Completed·Johnson & Johnson·Phase 2·NCT03842189·25 enrolled

Warm Autoimmune Hemolytic Anemia1 trial

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension

Active, not recruiting·Johnson & Johnson·Preclinical·NCT04119050·118 enrolled

Details

Drug Info

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