epicatechin (EB 002) / Epirium Bio - LARVOL DELTA

Inhibition of ATP synthase reverse activity restores energy homeostasis in mitochondrial pathologies. (PubMed, EMBO J) - "Inhibition of CV-ATP hydrolysis in a mouse model of Duchenne Muscular Dystrophy is sufficient to improve muscle force without any increase in mitochondrial content. We conclude that the impact of compromised mitochondrial respiration can be lessened using hydrolysis-selective inhibitors of CV."

Journal • Duchenne Muscular Dystrophy • Genetic Disorders • Muscular Dystrophy • ATP5IF1

The Metabolic Efficacy of a Cannabidiolic Acid (CBDA) Derivative in Treating Diet- and Genetic-Induced Obesity. (PubMed, Int J Mol Sci) - "All together, EPM301 ameliorated obesity and its metabolic abnormalities in both DIO and GIO. These results support the idea to further promote this synthetic CBDA derivative toward clinical evaluation in humans."

Journal • Dyslipidemia • Genetic Disorders • Hepatology • Liver Failure • Metabolic Disorders • Obesity • Prader–Willi syndrome

Safety and Biomarker Response to (+)-Epicatechin in Becker Muscular Dystrophy (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: Epirium Bio Inc. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Mar 2022 | Trial primary completion date: Dec 2021 ➔ Mar 2022

Biomarker • Trial completion • Trial completion date • Trial primary completion date • Becker Muscular Dystrophy • Duchenne Muscular Dystrophy • Muscular Dystrophy

Stimulatory effects of (-)-epicatechin and its enantiomer (+)-epicatechin on mouse frontal cortex neurogenesis markers and short-term memory: proof of concept. (PubMed, Food Funct) - "Frontal cortex-dependent short-term spatial working improved with (-)-Epi and (+)-Epi (15, 13%). In conclusion, results suggest that both enantiomers, but more effectively (+)-Epi, upregulate neurogenesis markers likely through stimulation of capillary formation and NO triggering, improvements in memory."

Journal • Preclinical • CD31 • NGF • NOS3

Safety and Biomarker Response to (+)-Epicatechin in Becker Muscular Dystrophy (clinicaltrials.gov) - P1; N=20; Active, not recruiting; Sponsor: Epirium Bio Inc.; Recruiting ➔ Active, not recruiting

Biomarker • Clinical • Enrollment closed • Becker Muscular Dystrophy • Duchenne Muscular Dystrophy • Muscular Dystrophy • MRI

Safety and Efficacy of (+)-Epicatechin in Subjects with Friedreich’s Ataxia: A Phase II, Open-Label, Prospective Study. (PubMed, J Inherit Metab Dis) - "(+)-EPI was well tolerated over 24 weeks at up to 150 mg/day. Improvement was observed in cardiac structure and function in subset of subjects with FRDA without statistically significant improvement in primary neurological outcomes."

Clinical • Journal • P2 data • Ataxia • Cardiovascular • Congestive Heart Failure • Friedreich ataxia • Heart Failure • Movement Disorders • Pediatrics • MRI

Safety and Biomarker Response to (+)-Epicatechin in Becker Muscular Dystrophy (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Epirium Bio Inc.; Not yet recruiting ➔ Recruiting

Biomarker • Clinical • Enrollment open • Becker Muscular Dystrophy • Muscular Dystrophy • MRI

Safety and Biomarker Response to (+)-Epicatechin in Becker Muscular Dystrophy (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Epirium Bio Inc.

Biomarker • Clinical • New P1 trial • Becker Muscular Dystrophy • Genetic Disorders • Muscular Dystrophy • MRI

Epirium Bio receives FDA Orphan-Drug Designation for EB 002 ((+)-epicatechin) for the treatment of Duchenne and Becker muscular dystrophy (Businesswire) - "Epirium Bio Inc….today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for its unique, orally available, synthetic flavanol EB 002 ((+)-epicatechin) for the treatment of Duchenne and Becker muscular dystrophy…’We are delighted that the data presented on EB 002 supported the FDA’s grant of an orphan-drug designation’."

Orphan drug

(+) Epicatechin to Treat Friedreich's Ataxia (clinicaltrials.gov) - P2; N=10; Completed; Sponsor: Ralitza Gavrilova; Active, not recruiting ➔ Completed

Clinical • Trial completion

Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study) (clinicaltrials.gov) - P1/2; N=7; Completed; Sponsor: Craig McDonald, MD; Recruiting ➔ Completed; N=10 ➔ 7

Clinical • Enrollment change • Trial completion

Plus Epicatechin Duchenne Muscular Dystrophy in Non-ambulatory Adolescents (clinicaltrials.gov) - P1/2; N=15; Completed; Sponsor: Craig McDonald, MD; Recruiting ➔ Completed

Clinical • Trial completion