LDT to Support Clinical Evaluation of a Drug for Painful Diabetic Neuropathy
Official title: Laboratory Developed Test (LDT) to Support Clinical Evaluation of a Drug for Painful Diabetic Neuropathy
Funded at Plumeria Therapeutics, INC. · NIH-11384238 · Data updated 2026-11-12
A lab-developed test is being developed to help tailor a drug treatment for people with painful diabetic neuropathy by matching it to patients’ biological markers.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Plumeria Therapeutics, INC. NIH-funded |
| Lab location | 1 site (Plainsboro, UNITED STATES) |
| Project start | September 20, 2021 |
| Project end | May 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $1,499,999 |
| NIH project number | 5R44NS120617-03 |
| Project ID | NIH-11384238 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with painful diabetic neuropathy who may be considered for the tested drug and for whom a biomarker-guided treatment decision could apply.
✕Less likely to help
Patients without the biomarker profile associated with a favorable response or those not receiving the targeted drug may not benefit from this test-directed approach.
What this research studies
This project aims to use a laboratory-developed test to guide the clinical evaluation of a therapy for painful diabetic neuropathy, focusing on biomarkers related to inflammation and chemokine signaling. By analyzing patient blood samples and gene expression related to the CCR2 receptor, the team hopes to identify which patients are most likely to benefit from the drug. The approach builds on prior trials and seeks to account for genetic differences that may affect treatment response. The work involves translating lab findings into a test that could inform clinical decisions in real-world care.
Why it matters
Potential benefit: If successful, the test could help personalize treatment for PDN and improve pain relief for patients who respond best to the drug.
How similar studies have gone: Previous trials showed the drug was safe and tolerable, and this project seeks to improve outcomes by incorporating genetic and biomarker information.
Where this research is happening
-
Plumeria Therapeutics, INC.
Plainsboro, United States Active
Researchers
- Principal investigator: Richardson, Thomas P — Plumeria Therapeutics, INC.
- Study coordinator: Richardson, Thomas P
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.