AnaMar has announced positive results from its Phase I study, and the completion of Phase II enabling pre-clinical studies, for AM1476’s initial orphan indication in systemic sclerosis (SSc) characterised by lung and skin fibrosis.
AM1476, a highly selective small molecule, delivered as an orally administered tablet, was found to be safe and well-tolerated at all relevant doses in a trial of approximately 100 healthy subjects.
Skin fibrosis is a leading feature of SSc associated with significant disability. Interstitial lung disease (ILD) is a group of conditions that cause progressive lung scaring, known as fibrosis, which lead to increasing, chronic, breathing problems and organ dysfunction, and eventually possible death.
There are currently no treatments on the market that effectively reverse scarring. AM1476 has been found to ameliorate key fibrotic pathways in vivo and ex vivo with the potential to halt and reverse scarring with potential utility across fibrotic disease.
A Phase II study has been designed to evaluate the treatment effects in SSc-ILD with a proposed dosing regimen for 60 patients in a double-blinded, placebo-controlled randomised trial over 12 months.
AnaMar’s Head of Research, Dr Christina Wenglén, said: “ILD and skin fibrosis are commonly seen complications of systemic sclerosis which are often progressive and have a poor prognosis. Which is why we see such great potential in AM1476 as a unique dual-action approach to treat skin and lung manifestations of systemic sclerosis, especially as it represses both macrophage and fibroblast activity.”