OLX702A / OliX Pharma, Eli Lilly - LARVOL DELTA

The MASH (metabolic dysfunction–associated steatohepatitis) and obesity therapy "OLX702A" has completed a phase 1 trial in Australia and is set to receive the clinical study report in the second half of this year. (Chosun Biz)

P1 data • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Daeshin Securities announced on June 23rd that OliX Pharmaceuticals (KOSDAQ: 226950) is broadening its therapeutic ambitions… (KBI Intelligence) - "Phase 1 trials have concluded, and OliX expects to receive the clinical study report (CSR) between August and October. Phase 2 enrolment and the associated milestone payments from Eli Lilly are then anticipated to follow...OLX501A, has produced encouraging early results. In a single-dose primate study, it reduced target messenger RNA by as much as 84%. More strikingly, when combined with tirzepatide (sold as Zepbound) at just one-tenth of the standard high dose, the drug maintained its fat-reduction effect while also blunting the weight rebound typically seen after treatment is stopped...Full data are scheduled to be disclosed at an R&D day on July 14th. The company is seeking to license the asset to a partner before initiating clinical trials....OliX is advancing a treatment for age-related macular degeneration, OLX301A...company plans to file an investigational new drug (IND) application for a multi-country phase 2 trial in the second half of this year..."

IND • New P2 trial • P1 data • Preclinical • Trial status • Age-related Macular Degeneration • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

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