TGF-beta superfamily-based ligand trap in development for the treatment of fibrosis in SSc-ILD.

Acceleron-discovered, ACE-1334 is designed to bind and inhibit TGF-beta 1 and 3 ligands but not TGF-beta 2. TGF-beta 1 and 3 are believed to be key signaling factors in the pathogenesis of fibrotic disease. ACE-1334 has shown robust anti-fibrotic activity in multiple preclinical models of fibrosis. An investigational product for Acceleron, ACE-1334 recently completed an ascending-dose Phase 1 clinical trial in healthy volunteers. The FDA has granted Fast Track designation to ACE-1334 in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) as well as Orphan Drug designation for the treatment of systemic sclerosis. Systemic sclerosis-associated interstitial lung disease (SSc-ILD; also known as systemic scleroderma-associated interstitial lung disease) is a rare, progressive, autoimmune connective tissue disorder characterized by immune dysregulation.

Acceleron intends to initiate a Phase 1b/Phase 2 trial in patients with SSc-ILD in 2021.