FM 101 / Femta - LARVOL DELTA

FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis (clinicaltrials.gov) - P2a; N=60; Not yet recruiting; Sponsor: Future Medicine

Clinical • New P2a trial • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • MRI

FM101 Safety, Tolerability, Efficacy Study in the Patients With Open-Angle Glaucoma or Ocular Hypertension (clinicaltrials.gov) - P1/2; N=64; Recruiting; Sponsor: Future Medicine

Clinical • New P1/2 trial • Glaucoma • Hypertension • Ophthalmology

A SAD, MAD, and FE Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of FM101 in Healthy Volunteers (clinicaltrials.gov) - P1; N=50; Completed; Sponsor: Future Medicine; Recruiting ➔ Completed; Trial completion date: Oct 2019 ➔ May 2020

Clinical • Trial completion • Trial completion date

[VIRTUAL] A randomized, double-blind, placebo-controlled, first-in-human single ascending dose, multiple ascending dose, and food effect study to evaluate the safety, tolerability, and pharmacokinetic profile of FM101 in healthy volunteers (EASL-ILC-I 2020) - "The prevalence of NASH gradually increases over time due to the epidemics of obesity and metabolic diseases including diabetes. There is no standard of care for this chronic type of disease so far. In this study, we demonstrated that FM101, a potential drug for treating NASH was generally well-tolerated up to 2400 mg (QD) and 600 mg (BID) in SAD and MAD studies, respectively."

Clinical • P1 data • PK/PD data • Diabetes • Fibrosis • Gastrointestinal Disorder • Genetic Disorders • Hepatology • Metabolic Disorders • Non-alcoholic Steatohepatitis • Obesity

Safety evaluation of FM101, an A3 adenosine receptor modulator, in rat, for developing as therapeutics of glaucoma and hepatitis. (PubMed, EXCLI J) - "However, there were no test substance-related changes or adverse effects observed during our ophthalmological, clinical chemistry, urine, organ weight, and histopathological analysis. These findings indicate that no observed adverse effect level of FM101 was 1000 mg/kg/day in male and female rats."

Journal • APP

A randomized, double-blind, placebo-controlled, first-in-human single ascending dose, multiple ascending dose, and food effect study to evaluate the safety, tolerability, and pharmacokinetic profile of fm101 in healthy volunteers (EASL-ILC 2020) - No abstract available

Clinical • P1 data • PK/PD data

Preclinical characterization of FM101, a first-in-class A3 adenosine receptor modulator for the treatment of non-alcoholic steatohepatitis (EASL-ILC 2019) - "The biased agonist of A3 adenosine receptor, FM101, could have therapeutic potential for the treatment of NASH through induction of mitochondria-mediated KCs death."

Preclinical

A SAD, MAD, and FE Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of FM101 in Healthy Volunteers (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Future Medicine

Clinical • New P1 trial