# Nezavist a Novel Molecule for Treatment of Alcohol Use Disorder

> **NIH NIH U44** · LOHOCLA RESEARCH CORPORATION · 2021 · $124,401

## Abstract

Abstract for Supplement Application
 The ultimate goal for our original project was to complete the proof-of-concept work, and the
multitude of pharmacodynamic, pharmacokinetic, toxicokinetic, safety, and toxicology studies required by the
FDA to apply for an IND. We are fully satisfied that we have generated a new chemical entity that acts at a
novel binding site on the GABA-A receptor and acts in the gut by interacting with the microbiome, the enteric
nervous system and the vagus nerve to block the significantly increased alcohol consumption in alcohol
dependent animals after a period of forced abstinence (model of relapse). We have completed all non-
clinical studies for an IND, and from our safety studies, we determined that our therapeutic dose in humans
should be well below a dose that would produce any toxicity. The IND application is being written, but a
critical issue remains to be addressed prior to IND submission. This issue centers on our plans to comply
with the FDA Guidance for Industry “cGMP for Phase 1 Investigational Drugs.” This Guidance details the
processes, controls, quality checks on purity and stability, and fidelity of dosage delivery for producing the
dosage forms to be used in the Phase 1 trials. The data and information on the production and testing of the
Phase 1 dosage forms must be included with the IND application. We have worked with Catalent Pharma in
the past to develop materials for dosing animals and have engaged them to produce the dosage forms for
humans. The development, production, and control of formulations for humans was not an aim of our original
application and funds were not allocated for this task. We are now asking for supplemental funds in order to
develop and produce the human dosage forms so that we can submit the IND application. Achievement of
this milestone will start us on the path for successful completion of clinical trials and to bringing an effective
medication to those suffering from AUD to return them to a non-addicted lifestyle.
Abstract from the Parent Grant Application
 Alcohol Use Disorder affects 7.9% of the U.S. population ages 18 and older and costs society over
$223 billion per year in direct medical costs, accidents, and lost productivity.
Current pharmacotherapy is only modestly effective and must be used in conjunction with psychosocial
treatment. Primary care physicians are ill equipped to provide the currently necessary range of therapy for
treating AUD and the modest effects of therapy generate a significant number of treatment failures. We
have generated a novel molecule with action directly at one of the major neurotransmitter receptors
altered by chronic excessive consumption of alcohol.
 We have also demonstrated in two different models of relapse drinking by alcohol dependent animals
that our medication can reduce or prevent such relapse. Our preliminary studies on the safety and
metabolism of our compound in animals provide confidence that the compound will have a go...

## Key facts

- **NIH application ID:** 10321981
- **Project number:** 3U44AA024905-05S2
- **Recipient organization:** LOHOCLA RESEARCH CORPORATION
- **Principal Investigator:** Boris Tabakoff
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $124,401
- **Award type:** 3
- **Project period:** 2015-09-25 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10321981

## Citation

> US National Institutes of Health, RePORTER application 10321981, Nezavist a Novel Molecule for Treatment of Alcohol Use Disorder (3U44AA024905-05S2). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10321981. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*