AM 1476 / AnaMar - LARVOL DELTA

Specific targeting of the 5-hydroxytryptamine 2B receptor (5-HT2BR) demonstrates antifibrotic effects in murine models and ex vivo models of scleroderma skin. (PubMed, Arthritis Rheumatol) - "We describe AM1476 as a highly selective inhibitor of 5-HT2BR. Treatment with AM1476 ameliorated fibrosis in three mouse models of SSc and normalized the expression of fibrosis-related genes directly in SSc skin. As AM1476 also demonstrated good tolerability in a phase I trial, further clinical trials with AM1476 are currently in the planning stage."

Journal • Preclinical • Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Rheumatology • Scleroderma • Systemic Sclerosis

AM1476 – A HIGHLY SELECTIVE 5-HYDROXYTRYPTAMINE 2B (5-HT2B) RECEPTOR ANTAGONIST AMELIORATING BOTH PULMONARY AND DERMAL FIBROSIS IN THE CHRONIC GRAFT VERSUS HOST DISEASE MODEL OF SYSTEMIC SCLEROSIS (SSWC 2024) - "Inhibition of 5-HT2B receptor activity resulted in anti-fibrotic effects in pulmonary and dermal fibrotic tissues. Amelioration of several processes related to fibroblast and macrophage activation was observed. The highly selective 5-HT2B receptor antagonist AM1476, represents a promising drug candidate for treatment of fibrotic conditions and is currently in phase II development for systemic sclerosis."

Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Systemic Sclerosis • SMAD3 • TGFB1

AnaMar Announces US and EU Orphan Drug Designation for AM1476 for Treating Systemic Sclerosis (GlobeNewswire) - "AnaMar...announces that the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have granted orphan drug designation (ODD) to its lead clinical candidate, AM1476 for the treatment of systemic sclerosis (SSc)....The company has designed a Phase II study to evaluate the treatment effects in SSc-ILD with a proposed dosing regimen for 60 patients in a double-blinded, placebo-controlled randomized trial over 12 months with lung function and skin thickness as efficacy readouts."

Clinical protocol • European regulatory • Orphan drug • Immunology • Systemic Sclerosis

Safety, Tolerability and Pharmacokinetics of AM1476 in Healthy Subjects (clinicaltrials.gov) - P1 | N=97 | Completed | Sponsor: AnaMar AB | N=72 ➔ 97

Enrollment change

AM1476/Placebo Study in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: AnaMar AB | Recruiting ➔ Completed | Trial completion date: Jun 2021 ➔ Jan 2022 | Trial primary completion date: Jun 2021 ➔ Jan 2022

Trial completion • Trial completion date • Trial primary completion date

AM1476/Placebo Study in Healthy Subjects (clinicaltrials.gov) - P1; N=72; Recruiting; Sponsor: AnaMar AB

Clinical • New P1 trial