Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » SMC Laboratories, Inc.

SMC Laboratories, Inc.

Table of Contents
Table of Contents

SMC Laboratories is a provider of drug evaluation testing & consulting services.High level of patented technologyThis section details examples of pathological models and case studies held by SMC Laboratories, which has Please use this as a reference when choosing a contracting company.

Features of SMC’s Contract Non-Clinical Study Services

Support for Diseases Lacking Established Disease Models

In the process of new drug development, models that accurately recapitulate the pathology of the target disease are required. At SMC Laboratories (SMC), even for diseases for which no model currently exists that can represent human pathology, the company can undertake the development of proprietary disease models. As a result, new drug development for untreated diseases can be enabled.

STAM™ Mouse: A Proprietary Disease Model

The STAM™ mouse—developed by SMC—mimics the progression from non-alcoholic steatohepatitis (NASH) to hepatocellular carcinoma (HCC). The disease progresses rapidly and shows a 100% incidence of hepatocarcinoma, making the model suitable for evaluating immunotherapies and molecularly targeted drugs. The tumor microenvironment can also be analyzed, and the model plays an important role in new drug development.

Extensive Experience in Liver Disease and Fibrosis

Over the past 10 years, SMC has provided services to more than 1,000 research institutions across 30+ countries, and studies using the patented STAM™ mouse have been published in numerous papers and presented at international conferences.

Reference: SMC Laboratories official website
https://www.smccro-lab.com/jp/service/#ser01

Examples of Disease Models Developed by SMC Laboratories, Inc.

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.

STAM™ Model

This model shows pathological progression similar to human MASH/NASH–liver cancer. Mimicking late-stage type 2 diabetes , the disease progresses from fatty liver to NASH, fibrosis, and liver cancer. The disease progresses over a short period, with 100% liver cancer at 20 weeks of age;, as a result of these characteristics, research using this model has been published in more than 70 papers to date.

Reference: Japan Science and Technology Agency – Life Science Database Cross Search
https://dbsearch.biosciencedbc.jp/Patent/page/ipdl2_JPP_an_2011524600.html

Unilateral Ureteral Obstruction (UUO) Model

UUO model is widely used as a renal fibrosis model. It exhibits interstitial fibrosis, tubular atrophy, and infiltration of inflammatory cells, which are characteristic pathological features of chronic kidney disease.

With a study duration of only two weeks, this model is well suited for in vivo screening studies of antifibrotic drug candidates for kidney fibrosis.

SMC Laboratories’ Nonclinical Case Studies

Phase 2 study in NASH-related liver cirrhosis

Galectin Therapeutics Inc. (NASDAQ: GALT) conducted a drug evaluation study targeting fibrosis in STAM™ mice, supporting a Phase 2 study in NASH-related liver cirrhosis.

*Reference: https://www.smccro-lab.com/jp/quality/

Ongoing Phase 2 study in NASH at the hepatic fibrosis stage

Can-Fite BioPharma Ltd. (NYSE American: CANF, TASE: CFBI) conducted a drug evaluation study targeting NASH using the STAM™ model. A Phase 2 study targeting NASH at the hepatic fibrosis stage is currently ongoing.

*Reference: https://www.smccro-lab.com/jp/quality/

SMC Laboratories, Inc. (SMC) Information

SMC supports more than 1,000 pharmaceutical companies and bio ventures in 30 countries around the world, including Japan and North America*.
SMC Group International, Inc., our U.S.-based group company, serves as the primary point of contact for clients in the United States.

Address Technoport Kamata Center Bldg.
2-16-1 Minami-Kamata Ota-City Tokyo 144-0035, Japan
Tel +1-949-756-8500
Website https://www.smccro-lab.com/

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