Accelerating Metabolic Disease Drug Discovery Through Translational Preclinical Research

In Vivo Pharmacology

Evaluating Therapeutic Efficacy in Relevant Metabolic Disease Models

Successful metabolic disease drug development requires clear evidence that a therapeutic candidate produces meaningful biological, functional, and disease-modifying effects. Franklin Biolabs provides customized in vivo pharmacology studies designed to evaluate therapeutic efficacy, characterize dose-response relationships, and assess target engagement across a broad range of disease-relevant metabolic models.

Our scientists collaborate closely with sponsors to design and execute studies that generate robust, reproducible, and decision-enabling data. By integrating disease-relevant models with translational endpoints, we help advance programs from early proof-of-concept through candidate selection and preclinical development.

Our capabilities include:

• Proof-of-concept and therapeutic efficacy studies
• Dose-ranging and dose-response characterization
• Disease progression and disease-modification assessment
• Customized study design and protocol development
• Diet-induced obesity (DIO) models
• Genetic models of obesity and diabetes
• Models of insulin resistance and glucose intolerance
• MASH/MASLD and liver fibrosis models
• Dyslipidemia and cardiometabolic disease models
• Transgenic and genetically engineered models for disease-specific mechanisms
• Longitudinal study designs supporting preclinical decision-making

Metabolic Disease Drug Delivery & Administration

Enabling Precise Therapeutic Delivery

Successful metabolic therapeutic development often depends on accurate and reproducible delivery to target tissues. Franklin Biolabs provides expertise in specialized administration techniques across multiple species, supporting studies involving biologics, small molecules, peptides, antibodies, RNA therapeutics, gene therapies, and advanced delivery platforms.

Our capabilities include:

• Oral administration
• Subcutaneous administration
• Intravenous administration
• Intraperitoneal administration
• Continuous infusion studies
• Systemic administration
• Support for biologics, small molecules, antibodies, peptide therapeutics, gene therapies, and RNA-based medicines
• Specialized dosing regimens for chronic metabolic disease studies

Metabolic Phenotyping & Functional Assessment

Measuring Outcomes That Matter

Functional and physiological endpoints often provide some of the most meaningful indicators of therapeutic benefit in metabolic disease research. Franklin Biolabs offers comprehensive metabolic phenotyping and functional assessment services that evaluate body composition, glucose regulation, insulin sensitivity, energy metabolism, and disease progression across a variety of metabolic disease models.

By integrating physiological outcomes with molecular biomarkers, PK/PD analyses, imaging, and histopathological findings, we help sponsors develop a comprehensive understanding of therapeutic activity, from target engagement and biological response to meaningful metabolic improvement.

This integrated approach strengthens translational confidence and supports informed candidate selection and preclinical development decisions.

Our capabilities include:

• Body weight and body composition assessment
• Food intake monitoring
• Glucose tolerance testing (GTT)
• Insulin tolerance testing (ITT)
• Hyperinsulinemic-euglycemic clamp studies
• Energy expenditure analysis
• Indirect calorimetry
• Metabolic cage studies
• Glycemic control assessment
• Functional outcome measures

Bioanalysis, Biomarkers & PK/PD

Connecting Drug Exposure to Biological Activity

Generating translational data is critical for understanding how therapies engage their targets and produce meaningful pharmacological effects. Franklin Biolabs provides integrated biomarker and PK/PD support to help sponsors characterize mechanism of action, establish exposure-response relationships, and strengthen confidence in candidate selection.

Our approach combines pharmacokinetic evaluation, pharmacodynamic assessment, target engagement strategies, and biomarker analysis to establish clear relationships between drug exposure, biological response, and efficacy outcomes.

Our capabilities include:

Pharmacokinetics & Pharmacodynamics

• PK analysis
• PD assessment
• Exposure-response modeling
• Target engagement
• Mechanism-of-action studies

Biomarker Analysis

• Glycemic biomarkers
• Insulin sensitivity biomarkers
• Lipid metabolism biomarkers
• Inflammatory biomarkers
• Liver injury and fibrosis biomarkers
• Cardiometabolic biomarkers
• Translational biomarker selection

Bioanalysis

• Plasma and tissue bioanalysis
• LC-MS/MS drug quantification in plasma, liver, adipose tissue, skeletal muscle, and other target tissues

Biodistribution

• Biodistribution studies
• Tissue distribution analysis
• Vector genome quantification (qPCR/ddPCR)
• Tissue-targeting assessment

Immunogenicity

• Anti-drug antibody (ADA) testing
• Humoral immune response
• Cellular immune response
• Titer assays
• Shedding studies

Preclinical Imaging

Visualizing Therapeutic Distribution, Disease Progression & Response

Advanced imaging technologies complement biomarker and PK/PD analyses by providing non-invasive assessment of therapeutic distribution, target engagement, disease progression, body composition changes, and treatment response. Franklin Biolabs offers preclinical imaging capabilities that support translational metabolic research by helping sponsors correlate imaging findings with molecular, pharmacological, and functional endpoints throughout preclinical development.

Imaging also enables longitudinal evaluation of disease progression and therapeutic response within the same subjects, strengthening translational confidence while supporting efficacy studies, biodistribution assessments, and treatment monitoring.

Our capabilities include:

• Magnetic Resonance Imaging (MRI)
• Computed Tomography (CT)
• Body composition imaging
• Liver imaging assessments
• Longitudinal imaging studies
• Imaging biomarker evaluation
• Image-guided procedures

Toxicology & Safety Assessment

Assessing Safety and Functional Risk

Comprehensive safety evaluation is essential for advancing metabolic therapeutics toward clinical development. Franklin Biolabs provides metabolic disease-focused toxicology and safety pharmacology services designed to assess treatment-related adverse findings, organ-specific toxicities, and potential metabolic liabilities.

Our capabilities include:

• Safety pharmacology studies
• General toxicology with metabolic-focused endpoints
• Liver safety assessments
• Cardiometabolic safety evaluations
• Clinical pathology support
• Organ toxicity assessment
• Tolerability studies

Histopathology & Tissue Analysis

Understanding Biological Impact

Histological and tissue-based analyses provide critical insight into disease pathology and therapeutic response. Franklin Biolabs offers comprehensive pathology and tissue analysis services that help characterize treatment effects at the cellular and molecular level.

Our scientists employ quantitative and qualitative approaches to evaluate liver pathology, inflammation, fibrosis, adipose tissue remodeling, pancreatic health, and biomarker expression, providing the biological context needed to support preclinical development decisions.

Our capabilities include:

• Histopathology
• Immunohistochemistry (IHC)
• Tissue biomarker analysis
• Liver pathology assessment
• Fibrosis analysis
• Adipose tissue characterization
• Quantitative pathology
• Cellular and molecular characterization
• Metabolic tissue analysis