OLX702A / OliX Pharma - LARVOL DELTA

A first in human study to Evaluate the Safety and Tolerability of OLX75016 for treatment of nonalcoholic steatohepatitis (NASH) and liver fibrosis. (ANZCTR) - P1 | N=58 | Completed | Sponsor: OliX AU Pty Ltd | Recruiting ➔ Completed

First-in-human • Trial completion • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple- Ascending Dose Study to Evaluate the Safety and Tolerability of OLX75016 in Healthy Volunteers and Patients with Non-Alcoholic Fatty Liver Disease. (ANZCTR) - P1 | N=40 | Recruiting | Sponsor: OliX AU Pty Ltd | N=28 ➔ 40

Enrollment change • Fibrosis • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

OliX strikes $630 million deal with Lilly for obesity and liver disease drug (Korea Biomedical Review) - "OliX Pharmaceuticals, a Korean biotech company specializing in RNA interference (RNAi) therapies, has signed an exclusive global licensing deal with Eli Lilly worth up to $630 million....OliX will continue conducting phase 1 clinical trials of OLX75016 in Australia, after which Lilly will take over subsequent development and commercialization. OliX will receive upfront and milestone-based payments tied to clinical progress."

Licensing / partnership • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Olix, Eli Lilly and Establish Licensing Agreement for Fatty Hepatitis and Metabolic Disease Treatments [Google translation] (Money Today Network (MTN)) - "Olix announced on the 7th that it has signed a licensing agreement with global pharmaceutical company Eli Lilly & Company. This collaboration aims to develop and commercialize Olix's 'OLX702A', a clinical phase 1 candidate targeting metabolic abnormalities (MASH) and other cardiovascular and metabolic diseases. Through this agreement, Olix will receive an upfront payment from Lilly and complete the Australian phase 1 clinical study of 'OLX702A'."

Licensing / partnership • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple- Ascending Dose Study to Evaluate the Safety and Tolerability of OLX75016 in Healthy Volunteers and Patients with Non-Alcoholic Fatty Liver Disease. (ANZCTR) - P1 | N=28 | Recruiting | Sponsor: OliX AU Pty Ltd | N=20 ➔ 28

Enrollment change • Fibrosis • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple- Ascending Dose Study to Evaluate the Safety and Tolerability of OLX75016 in Healthy Volunteers and Patients with Non-Alcoholic Fatty Liver Disease. (ANZCTR) - P1 | N=20 | Recruiting | Sponsor: OliX AU Pty Ltd

New P1 trial • Fibrosis • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Nonclinical Pharmacokinetics Study of OLX702A-075-16, N-Acetylgalactosamine Conjugated Asymmetric Small Interfering RNA (GalNAc-asiRNA). (PubMed, Drug Metab Dispos) - "Significance Statement This study presents the first comprehensive characterization of the in vivo pharmacokinetics of GalNAc-asiRNA. The pharmacokinetic insights gained from this research will aid in understanding toxicology and efficacy, optimizing delivery platforms, and improving the predictive power of preclinical species data for human applications."

Journal • PK/PD data • Developmental Disorders • Hepatology

A first in human study to Evaluate the Safety and Tolerability of OLX75016 for treatment of nonalcoholic steatohepatitis (NASH) and liver fibrosis. (ANZCTR) - P1 | N=70 | Recruiting | Sponsor: OliX AU Pty Ltd | Initiation date: Feb 2024

Trial initiation date • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

A first in human study to Evaluate the Safety and Tolerability of OLX75016 for treatment of nonalcoholic steatohepatitis (NASH) and liver fibrosis. (ANZCTR) - P1 | N=70 | Recruiting | Sponsor: OliX AU Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Olyx, ’GalNAc applied’ NASH∙HBV animal model results? [Google translation] (Biospectator) - "OliX Pharmaceuticals released a positive animal model study result for a new drug candidate under development for liver diseases such as nonalcoholic steatohepatitis (NASH) and hepatitis B (HBV)...The asiRNA pipeline applied with GalNAc technology introduced by AM Chemicals (AMC) in March of last year, 'OLX702A', a candidate for HBV treatment, significantly reduced HBV antigen and DNA."

Preclinical • Hepatitis B • Infectious Disease