Nonopioid peptide therapy to reset nerve pain biology
Official title: FDA Phase 1 Development of a Novel Nonopioid Cell and Tissue Permeable Peptide Therapeutic for Epigenetic Reprogramming of Neuropathic Pain
Funded at Alcamena Stem Cell Therapeutics, LLC · NIH-11387927 · Data updated 2026-11-12
A new, first‑in‑class peptide medicine (ASCT‑83) is being developed to target the biology of neuropathic pain in adults, with early human testing planned after successful preclinical work.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Alcamena Stem Cell Therapeutics, LLC NIH-funded |
| Lab location | 1 site (Baltimore, UNITED STATES) |
| Project start | August 7, 2025 |
| Project end | July 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $1,500,000 |
| NIH project number | 5R44NS145934-02 |
| Project ID | NIH-11387927 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults 21 years and older with neuropathic or related chronic pain conditions who are eligible for early-phase clinical testing.
✕Less likely to help
Individuals without neuropathic pain or those unable to participate in early clinical testing may not benefit.
What this research studies
Neuropathic pain affects millions and current options often fail to address underlying mechanisms, sometimes leading to opioid use. This project tests a novel peptide that enters cells and tissues to promote normal gene expression in nervous tissue, aiming to reduce pain at its source. The effort builds on completed preclinical studies and an FDA Safe to Proceed IND, moving toward early human testing in adults. If successful, the therapy could provide a nonopioid option with potential additional benefits for nerve injury–related motor function. The team at AlcAMENA Stem Cell Therapeutics is coordinating the work with support from NIH funding over the next two years.
Why it matters
Potential benefit: If successful, patients with neuropathic pain could gain a nonopioid treatment that targets disease mechanisms and may improve pain and function.
How similar studies have gone: Past studies of mechanistically targeted neuropathic pain therapies have shown promise in early stages, but this approach is first‑in‑class for REST pathway modulation.
Where this research is happening
-
Alcamena Stem Cell Therapeutics, LLC
Baltimore, United States Active
Researchers
- Principal investigator: Nesti, Edmund — Alcamena Stem Cell Therapeutics, LLC
- Study coordinator: Nesti, Edmund
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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.