# IND-enabling studies on novel Cav3 T-channel modulators for treatment of neuropathic pain

> **NIH NIH R44** · AFASCI, INC. · 2020 · $1,491,584

## Abstract

7. PROJECT SUMMARY
Neuropathic pain remains a poorly managed medical condition affecting more than 1.5 billion people
worldwide. Over 20 million people suffered from diabetic neuropathy and neuropathic pain in the US alone in
2015. The current standard of care is insufficient. Topical applications and systemic treatment with existing
analgesics, including opioids, leave millions suffering. More than 50% of these patients are refractory to
medication. Opioids frequently cause devastating side effects, and overdose has claimed 300,000 lives in the
United States since 2000. The lack of effective analgesics for chronic pain has contributed to the opioid crisis.
To address this National Health Emergency, we at AfaSci Research Laboratories have discovered non-opioid
new class of compounds to treat neuropathic pain with the SBIR Fast-Track grant support. Our compounds
possess much greater potency and selectivity to modulate the T-type Cav3.2 channel than all currently known
T-channel inhibitors. Rigorous in vivo pharmacokinetic and pharmacodynamic (PK/PD) studies and preliminary
toxicological studies have provided valuable scientific insights that enabled AfaSci to select AFA-279, along
with several backup candidates, for the IND-enabling studies proposed in this SBIR Phase IIB project.
At their efficacious doses, our new compounds did not produce observable side-effects frequently experienced
with existing pain therapeutics. We have conducted multiple tests comparing the effectiveness of these new
compounds against a current neuropathic pain medication, gabapentin. Our compounds showed greater
analgesic effects than gabapentin in multiple rodent neuropathic pain models. The goal of this proposed SBIR
Phase IIB project is to submit the IND application on our Cav3.2 modulator to the Food and Drug
Administration (FDA). To achieve this goal, three Specific Aims must be accomplished: 1) produce AFA-279
under Good Manufacturing Practice (GMP)-like conditions using chemical manufacturing controls (CMC) for
GLP nonclinical toxicity studies and GMP clinical batch future Phase 1 clinical trials, 2) complete toxicological
and safety studies under Good Laboratory Practice (GLP) to establish the safety profile of AFA-279 and 3)
prepare and submit the IND application for our novel T-channel modulator to the FDA.
Our investigative team (PI Dr. Xie, Chemist Dr. Kayser, Pharmacologist Dr. Zou, and Project Manager Dr.
Greene) with consultants (Toxicologist Dr. Tepper and Statistician Dr. Yang), and our Scientific Advisors will
collaborate with Stanford Medical School and contract research organizations (Regis Technologies, Charles
River Laboratories and AnaBios) to ensure successful completion of this exciting project.
Success in this project will lead to a successful FDA IND filing of our Cav3.2 modulator. We will then initiate
early clinical trials on our novel T-channel modulator with our strategic partners, Cavion and/or Biohaven. Our
ultimate goal is to deliver a s...

## Key facts

- **NIH application ID:** 9786245
- **Project number:** 5R44NS086343-05
- **Recipient organization:** AFASCI, INC.
- **Principal Investigator:** Xinmin Simon Xie
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,491,584
- **Award type:** 5
- **Project period:** 2014-07-01 → 2023-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9786245

## Citation

> US National Institutes of Health, RePORTER application 9786245, IND-enabling studies on novel Cav3 T-channel modulators for treatment of neuropathic pain (5R44NS086343-05). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9786245. Licensed CC0.

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