Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » PhoenixBio Co., Ltd.

PhoenixBio Co., Ltd.

Table of Contents
Table of Contents

PhoenixBio Co., Ltd.specializes in studies using PXB mice, a high-quality human hepatocyte chimeric mouse model. The following summarizes the features of PhoenixBio Co., Ltd.’s nonclinical studies, an example of a disease model, and representative case studies. Use this information when evaluating contract research providers.

Features ofPhoenixBio Co., Ltd.’s Contract Non-Clinical Testing Services

Use of human hepatocyte chimeric mice (PXB mice)

PhoenixBio Co., Ltd. specializes in nonclinical studies using PXB mice. In this model, ≥70% of the liver is replaced with human hepatocytes, which more closely reflects drug metabolism in humans. This enables pharmaceutical sponsors to obtain reliable data to evaluate the efficacy and safety of new compounds under conditions that closely approximate human physiology.

Extensive animal disease models

PhoenixBio Co., Ltd. maintains a diverse portfolio of animal disease models and conducts nonclinical studies across a broad range of indications. In new drug development targeting specific diseases, PhoenixBio selects appropriate models and conducts rapid, efficient efficacy evaluations, enabling timely generation of the required data.

High-quality safety and efficacy/pharmacology studies

Safety studies and efficacy/pharmacology studies are conducted in accordance with applicable guidelines, providing reliable data for critical stages of drug development.

Examples of Disease Models Offered by PhoenixBio Co., Ltd.

It is essential to go through the testing of candidate compounds in animal models that reproduce the target disease before advancing to clinical trials.

However, clinically relevant disease models may not always exist, thus there are demands for animal models with strong clinical correlation.

Below are some examples of disease models offered at Ina Research.

MASH Disease Model – "MASH-c/PXB® Mouse"

A NASH-like disease model generated by feeding PXB mice (human hepatocyte chimeric mice) a CDAHFD diet (choline-deficient, amino acid-restricted, very high-fat diet) for 12 weeks. Hepatocyte ballooning and Mallory–Denk–like bodies can be observed, along with inflammatory responses and elevated human ALT-1.

NASH disease model: “NASH-g/PXB mouse”

A NASH-like disease model generated by feeding human hepatocyte chimeric mice a GAN diet for 30 weeks. Hepatocyte ballooning and Mallory–Denk–like bodies can be observed, along with inflammatory responses and elevated human ALT-1.

PhoenixBio Co., Ltd. Non-Clinical Case Studies

Human PK prediction (quantitative prediction)

PXB mice, monkeys, and rats were used to compare and evaluate predicted human clearance for 30 compounds. By comparing initial pharmacokinetic parameters, it is possible to assess absorption from the gastrointestinal tract, distribution to tissues, hepatic metabolism, and urinary elimination. This assessment supports the design of drugs with favorable efficacy and safety profiles and the planning of appropriate clinical studies.

Reference: PhoenixBio Co., Ltd. official websitehttps://phoenixbio.co.jp/services/dmpk-studies.html

Human metabolite prediction (qualitative prediction)

Lamotrigine was used to predict human metabolites by comparing data from PXB mice with control mice. By observing the in vivo time course, blood-level monitoring and the effects of multi-drug co-administration can be evaluated.

Reference: PhoenixBio Co., Ltd. official websitehttps://phoenixbio.co.jp/services/dmpk-studies.html

PhoenixBio Co., Ltd. Company Information

PhoenixBio Co., Ltd. is developing a new business that provides human hepatocyte functionality in an easy-to-use format for a variety of applications. The company consistently produces more than 4,000 PXB mice per year.

Address 3-4-1 Kagamiyama, Higashihiroshima City, Hiroshima Prefecture, Japan
Tel 082-431-0016
Website https://phoenixbio.co.jp/

3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise

In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.

Pharmacology (Efficacy) StudiesDisease-Relevant Models for
Translational Drug Evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)

SMC Laboratories, Inc.

SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.

Areas of Expertise
Disease-Relevant Model Portfolio

SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.

Study Design Based on Target Biology

Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.

Support from Target Validation to Proof of Concept

With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.

Safety StudiesComprehensive Safety Assessment for
Preclinical Development
Charles River Laboratories
Reference: Charles River Laboratories official website (https://www.criver.com/)

Charles River Laboratories

Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.

Areas of Expertise
General Toxicology Across Study Designs

Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.

Non-GLP and GLP Study Support

Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.

Integrated IND-Enabling Safety Assessment

Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.

Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with
Pharmacological Response
Inotiv
Reference: Inotiv official website (https://www.inotiv.com/)

Inotiv

Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.

Areas of Expertise
Pharmacokinetic Characterization

PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.

Exposure–Response Evaluation

Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.

Integrated DMPK and Development Support

Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.

By Therapeutic Area
Disease Animal Models
and Reviews
Proven Capability, Expertise and Track Record
Top 3 Non-Clinical CRO Services