# A novel therapeutic to ameliorate chronic pain and reduce opiate use

> **NIH NIH UH3** · LOHOCLA RESEARCH CORPORATION · 2023 · $1,925,647

## Abstract

Over 100 million adults in the U.S. suffer from intermittent or constant chronic pain, and chronic pain affects at
least 10% of the world’s population. The primary pharmaceuticals for treatment of chronic pain have been natural
or synthetic opioids and the use of opioids for pain treatment has resulted in what has been called an “epidemic”
of opioid abuse, addiction and lethal overdoses. We have, through a process of rational drug design, generated
a new chemical entity (NCE) and have given it the name Kindolor. Kindolor is a non-opiate, non-addicting
molecule that was developed specifically to simultaneously control the aberrant activity of three targets on the
peripheral sensory system that are integral in the development and propagation of chronic pain. Kindolor acts
as an inhibitor of the pain propagating Nav1.7 and Nav1.8 sodium channels and as an inhibitor of NMDA receptors
that act to magnify pain signals (Fig A). We have generated a process to synthesize Kindolor at 99% purity. In
our pre-clinical studies we have demonstrated the efficacy of Kindolor to reduce or eliminate chronic pain
generated in five animal models at doses compatible with use of Kindolor in humans. We have generated
evidence that this broad range of efficacy is a result of the multi-target engagement by Kindolor. We have
generated the initial evidence for the safety (high TI) of Kindolor and its uneventful metabolism. Additional
attractive features of Kindolor are that it can prevent the development of chronic pain if given soon after tissue
injury. And if combined with low doses of opiates, Kindolor produces a substantial “opiate sparing” effect through
synergistic actions with the opiates. To bring Kindolor to the public, we are proposing to complete the pre-clinical
studies necessary for an IND application to the FDA and, if the IND is approved, the completion of a Phase 1a
and 1b, first in human, study of the safety of our compound, and then a Phase 2a study of efficacy on pain of
osteoarthritis. To start, we will have Kindolor synthesized using cGMP procedures. This will include development
of methods for scaling up production quantities. We will produce a formulation for oral drug administration to
humans and will use this formulation for GLP studies of pharmacokinetics and toxicokinetics in two species of
animals (rat and minipig). We will complete GLP studies of safety of the formulation in the two species, including
escalating dose experiments and sub-chronic dosing for 28 days with low, moderate, and high doses of the drug
product. These studies will include a 14 day recovery period to assess delayed toxicity. Genotoxicity studies will
also be completed, as will specific assessments of cardiovascular and respiratory toxicity prior to a pre-IND
meeting with the FDA. The satisfactory completion of the pre-IND meeting will allow for expedient completion of
the IND application. Given approval of the IND application, we propose to complete the Phase Ia and 1b stud...

## Key facts

- **NIH application ID:** 10653196
- **Project number:** 5UH3DA047680-05
- **Recipient organization:** LOHOCLA RESEARCH CORPORATION
- **Principal Investigator:** Boris Tabakoff
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,925,647
- **Award type:** 5
- **Project period:** 2019-03-15 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10653196

## Citation

> US National Institutes of Health, RePORTER application 10653196, A novel therapeutic to ameliorate chronic pain and reduce opiate use (5UH3DA047680-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10653196. Licensed CC0.

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