KDMN

Belumosudil (KD025) (Selective ROCK2 inhibitor)

Chronic Graft versus Host Disease (cGVHD)

NDA Acceptance

Exp Date

TBD

Amp Volatility Score

N/A

Catalyst Info & Data Links

TITLE: Belumosudil (KD025) for Chronic Graft versus Host Disease (cGVHD) 

  • ClinicalTrials.gov (NCT02841995) A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease


WHAT IS THE CATALYST EVENT?

  • NDA Acceptance


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

  • TBD


PRIOR DATA

PRESS RELEASES

MECHANISM OF ACTION

  • KD025 is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response. In addition to cGVHD, KD025 is being studied in an ongoing Phase 2 clinical trial in adults with diffuse cutaneous systemic sclerosis (KD025-209). KD025 was granted Breakthrough Therapy Designation and Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with cGVHD who have received at least two prior lines of systemic therapy.

MARKET

  • cGVHD is a common and often fatal complication following hematopoietic stem cell transplantation. In cGVHD, transplanted immune cells (graft) attack the patient's cells (host), leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joints, liver, lung, esophagus and gastrointestinal tract. Approximately 14,000 patients in the United States are currently living with cGVHD, and approximately 5,000 new patients are diagnosed with cGVHD per year.

Updated by HC

#KDMN, #Chronic Graft versus Host Disease, #cGVHD, #Belumosudil, #KD025, #Selective ROCK2 inhibitor, #immune response, #immunity, #transplant, #donor bone marrow, #stem cells 

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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