MESO

REMESTEMCEL-L

Crohn’s Disease

Stage (next event)

Expected Date

Phase 2

TBD

Catalyst Info & Data Links

TITLE: REMESTEMCEL-L in Crohn’s Disease 

  • ClinicalTrial.gov (NCT04548583): Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis


WHAT IS THE CATALYST EVENT?

  • Phase 2 Data


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • TBD


PRIOR DATA/EVENTS

PRESS RELEASE

Mechanism of Action

MECHANISM OF ACTION / RATIONALE

  • remestemcel-L is a tier 2 product candidate which consists of 100 million mesenchymal stem cells (MSCs). All doses of remestemcel-L for the treatment of Crohn’s disease consist of 100 to 200 million MSCs delivered intravenously in a multiple dose regime.

  • remestemcel-L has demonstrated immunomodulatory properties in preclinical studies to regulate T-cell mediated inflammatory responses by inhibiting T-cell proliferation and down-regulating the production of the pro-inflammatory cytokines, including tumor necrosis factor-alpha, or TNF-alpha, and interferon gamma. More critically, MLCs have been shown to be capable of effective down-regulation of Th17 cells, reduction in IL-17 levels, and induction of FOXP3 regulatory T cells. These inflammatory pathways are acknowledged to be central to the pathogenesis of Crohn’s disease and other inflammatory conditions.

  • Learn more HERE

COMPETITORS

MARKET

  • The United States has the highest prevalence of the disease, with more than 600,000 people afflicted and approximately 20,000 new cases diagnosed each year. 

  • Of the 600,000 American patients, studies have shown that approximately 8-20% are unresponsive, resistant or intolerant to existing treatments, which include corticosteroids, immunosuppressants and biologics2. 

  • The global Crohn’s disease therapeutics market was estimated to be worth $4.4 billion in 2012.

Updated by HC

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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