Receptor antagonist AM1476 was developed as an anti-fibrotic treatment for lung and skin disorders.
AnaMar has announced positive results from its phase 1 research relating to the use of its peripheral 5-HT2B receptor antagonist, AM1476, as a treatment for systemic sclerosis (SSc) characterised by lung and skin fibrosis.
AM1476 is a selective small molecule, provided as an orally administered tablet, and was discovered to be safe and well-tolerated at all relevant doses across a study of nearly 100 healthy individuals.
The candidate has also been found to ameliorate key fibrotic pathways in vivo and ex vivo with the potential to halt and reverse scarring with potential utility across the fibrotic disease.
Meanwhile, a phase 2 clinical trial has also been designed to evaluate the treatment effects in SSc, with a dosing regimen among 60 patients during a year-long, placebo-controlled randomised trial assessing lung function and skin thickness.
Dr Christina Wenglén, head of research at AnaMar, was optimistic about the results: “We see such great potential in AM1476 as a unique dual-action approach to treat skin and lung manifestations of SSc, especially as it represses both macrophage and fibroblast activity. We are committed to progressing our novel therapeutics into clinical practice to address this pressing unmet medical need.”
Dr Ulf Ljungberg, chief executive officer at AnaMar, concluded: “We hold a broad, patent-protected, portfolio of selective and high affinity 5-HT2B receptor antagonists. We have seen great potential from our pre-clinical and phase 1 studies, and now look forward to working with a pharma partner to turn our research into life-changing treatments for patients with fibrosis.”
At present, AnaMar is planning regulatory submissions, later in the year, to the US Food and Drug Administration and European Medicines Agency for orphan drug designation.