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New Drugs for Immune Diseases

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Immune disorders are diseases that arise when the immune system mistakenly attacks the body’s own tissues. Because these conditions affect many people, the development of new drugs remains a priority. Nonclinical studies are an essential part of the new-drug development process.

Nonclinical studies are the initial stage for assessing a new drug’s efficacy and are conducted in animal models. Results from this stage provide the foundation for advancing to clinical trials. Below are examples of new-drug development for immune disorders and the type of nonclinical testing used in each.

Development Case Study: Nagoya City University

Nagoya City University developed an antibody drug candidate for autoimmune diseases through collaborative research. The candidate was generated using ALAgene® technology, a proprietary platform of Pharma Foods Co., Ltd., which produces chicken-derived antibodies with high binding strength. An application to initiate a clinical trial for this candidate was accepted by the Pharmaceuticals and Medical Devices Agency (PMDA).

Nonclinical Studies

This program—conducted in collaboration with Professor Emeritus Mamoru Sato and Professor Emeritus Michiyuki Yamada of Yokohama City University, and Lecturer Satoshi Kanazawa of Nagoya City University—advanced through nonclinical studies supporting the candidate’s progression. An IND application for the antibody candidate was accepted by PMDA.

Reference: Sumitomo Pharma official websitehttps://www.sumitomo-pharma.co.jp/sukoyaka/medicine/untilmade/article3/

Development Case Study: Keio University

At Keio University, research on the treatment of rheumatoid arthritis (RA) has focused on improving outcomes in a disease where the immune system attacks the soft tissues of the joints, causing inflammation and joint destruction. Although multiple new drugs are effective for RA, approximately 10–20% of patients do not achieve symptom improvement with available treatments. Clinical trials aimed at preventing RA onset in at-risk populations are also being conducted worldwide.

Nonclinical Studies

While a combination of methotrexate and biologic agents is recommended as standard of care, clinical trials have evaluated methotrexate dose-reduction strategies to lessen adverse effects and financial burden.

Reference: Keio University official websitehttps://www.med.keio.ac.jp/features/2023/6/8-139303/index.html

Summary

Nonclinical studies play a critical role in the development of new drugs for immune disorders. The case studies from Nagoya City University and Keio University illustrate different approaches to assessing candidate therapies and paving the way to clinical trials. These efforts are expected to inform future therapies, as pharmaceutical companies and biotech ventures apply the latest research to advance new drug development.

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

In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D. In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening. Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.

Pharmacology (Efficacy) Studies
Replicate unknown pathological models and
Discovery to clinically oriented drug evaluation

SMC Laboratories, Inc.

Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)

SMC Laboratories, Inc. has established a disease models using patented mouse technologies. The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project. Their collaborative approachallows researchers to discuss and refine study plans together with SMC’s expert scientists.
With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.

Consult study design and disease model development
with SMC Laboratories, Inc.

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Safety Studies
Comprehensive Safety Evaluation for FIH Applications

Labcorp Holdings Inc.
(Labcorp Drug Development)

Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)

Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements. All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials. For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.

Consult Labcorp Holdings Inc.
Discuss GLP/ICH-compliant study design for your FIH submission.

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Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation

PhoenixBio Co., Ltd.

Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)

PhoenixBio Co., Ltd.offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to-drug interaction studies, bridging the gap between preclinical and clinical stages.
With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offersan integrated evaluation analysiscovering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics. For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.

Consult Phoenix Bio for PK/PD analysis with a clinical focus

Phoenix Bio.
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