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R&D in Neurodegenerative Diseases

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Neurodegenerative diseases are progressive disorders characterized by the gradual loss of function in brain and nerve cells. Alzheimer’s disease (AD) and Parkinson’s disease (PD) are representative examples. In drug discovery, many companies have pursued and evaluated innovative treatments, and nonclinical studies play a central role. The following article outlines how new drugs for neurodegenerative diseases have been developed through past case studies.

Case Study: Eisai Co., Ltd. × DZNE

Eisai Co., Ltd. is collaborating with the German Center for Neurodegenerative Diseases (DZNE) to develop novel therapeutic candidates for AD and other neurodegenerative disorders. The collaboration aims to create new therapies by leveraging immune regulation in neuronal and glial cells. DZNE is a public institution that advances interdisciplinary research on the prevention, diagnosis, and treatment of neurodegenerative diseases across multiple sites in Germany. Combining Eisai’s drug discovery experience with DZNE’s expertise is accelerating the generation of new therapeutic candidates.

Nonclinical Studies

Eisai, with extensive experience in the neurodegenerative disease field, and DZNE, with expertise in basic and clinical research, contribute knowledge and technical capabilities to disease-process research through coordinated basic and clinical research activities.

Reference: Eisai Co. official websitehttps://www.eisai.co.jp/news/2021/news202115.html

Case Study: Ono Pharmaceutical Co., Ltd. × Neurimmune

Ono Pharmaceutical Co., Ltd. has partnered with Neurimmune AG (Switzerland) to develop therapeutic antibodies for neurodegenerative diseases. Using Neurimmune’s RTM™ technology, the collaboration generates human monoclonal antibodies against new drug targets. This partnership is accelerating the development of therapeutics for multiple neurodegenerative diseases, including AD, PD, and amyotrophic lateral sclerosis (ALS).

Nonclinical Studies

Under the Ono–Neurimmune collaboration, an anti-miSOD1 antibody for ALS and the anti-ATTR antibody NI006 for ATTR cardiomyopathy have been discovered, and these programs are undergoing nonclinical testing.

Reference: Ono Pharmaceutical Co. official website PDFhttps://www.ono-pharma.com/sites/default/files/ja/news/press/new_スイスNeurimmune社と神経変性疾患領域で新たな創薬提携契約を締結_20220117.pdf

Summary

In drug discovery for neurodegenerative diseases—of which AD and PD are representative—many companies have pursued and evaluated innovative treatments. As illustrated by Eisai Co., Ltd. and Ono Pharmaceutical Co., Ltd., nonclinical studies are critical to establishing the efficacy and safety of new candidates. As development advances, continued research and testing are expected.

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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