AM1476 FOR TREATMENT OF SYSTEMIC SCLEROSIS

AM1476 is an oral, small molecule, selective, high-affinity 5-HT2B receptor antagonist. The anti-fibrotic efficacy of AM1476 has been clearly demonstrated in several preclinical state-of-the-art models of fibrosis, whereby AM1476 halted and reversed the progression of pre-established fibrosis in skin and lung tissue.

Its safety profile is currently being evaluated in healthy volunteers. This Phase I study will be followed by studies designed to evaluate the treatment effects in patients, initially focusing on systemic sclerosis followed by other fibrotic conditions.

Timeline

Indications

Systemic Sclerosis

Interstitial Lung Diseases

Other Indications

Discovery

Preclinical

Phase 1

Phase 2

Systemic Sclerosis

Interstitial Lung Diseases

Other Indications

Systemic sclerosis

Systemic sclerosis (SSc) is a severe, rare, chronic autoimmune disease with high morbidity and mortality. About 80 percent of SSc patients are women. The disease process in SSc includes overactivation of the immune system with damage to small blood vessels and increased fibroblast activation resulting in fibrosis of the skin and internal organs, including lungs, heart, kidneys and the gastrointestinal tract.

Other indications

Other indications of high interest for treatment with AM1476 or related compounds include interstitial lung diseases, liver fibrosis, cardiac fibrosis, fibrotic tumors as well as graft-versus-host disease.