L-leucine/L-isoleucine/L-valine/L-lysine HCL/L-histidine/L-threonine/L-ornithine L-aspartate (AXA1665) / Axcella - LARVOL DELTA

EMMPOWER: Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy (clinicaltrials.gov) - P2 | N=12 | Terminated | Sponsor: Axcella Health, Inc | N=150 ➔ 12 | Trial completion date: Mar 2023 ➔ Jun 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Mar 2023 ➔ Jun 2022; Sponsor is stopping the study to focus company resources on other development programs.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis

Pharmacokinetics of AXA1665, a Novel Composition of Amino Acids, in Comparison With Protein Supplement: A Single-Dose, Open-Label, Randomized Study in Healthy Subjects. (PubMed, Clin Pharmacol Drug Dev) - "AXA1665 19.6 g resulted in 1.5- to 9.5-fold higher systemic exposure to all AXA1665-dosed AAs except for aspartic acid and lysine and lower exposure to all nondosed AAs except for glutamine and alanine versus protein supplement. AXA1665 doses, up to 39.2 g, can deliver AXA1665-dosed AAs in the systemic circulation in the linear AUC range."

Journal • PK/PD data

EMMPOWER: Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Axcella Health, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis

[VIRTUAL] AXA1665 SHOWS DOSE-DEPENDENT ALTERATIONS IN METABOLIC PROFILE, INCLUDING REDUCTION OF NON-DOSED AROMATIC AMINO ACIDS, THAT DIFFERENTIATE IT FROM PROTEIN SUPPLEMENT IN HEALTHY SUBJECTS (AASLD 2021) - "AXA1665 dose-dependently reduces levels of non-dosed ArAAs, which are known to be elevated in cirrhosis and implicated in the pathogenesis of OHE, while increasing BCAAs, EAAs and UCAAs in a near dose-proportional manner. In contrast, PS administration results in increased systemic exposure of ArAAs . Thus, AXA1665 has the potential to address underlying AA imbalances associated with OHE in a targeted manner ."

Clinical • CNS Disorders • Cognitive Disorders • Fibrosis • Hepatic Encephalopathy • Hepatology • Immunology • Sarcopenia

Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy Eficacia y seguridad de AXA1665 en sujetos cirróticos con encefalopatía hepática manifiesta previa (clinicaltrialsregister.eu) - P2; N=150; Ongoing; Sponsor: Axcella Health, Inc.

New P2 trial • CNS Disorders • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis • MRI