NOVEL 5-HT2A/MGLUR5 ANTAGONIST FOR OPIOID USE DISORDER - OPIOID OVERDOSE DEATHS CONTINUE TO BE A MAJOR PUBL…

Assistance award details

Assistance award identifier

ASST_NON_UG3DA063353_075

FAIN

UG3DA063353

Recipient

VIRGINIA COMMONWEALTH UNIVERSITY

Awarding agency

Department of Health and Human Services

Funding agency

Department of Health and Human Services

Assistance listing (CFDA)

93.279

Total obligated

$2,290,412

Period

Sep 15, 2025 – Aug 31, 2027

Fiscal year

2025

Place of performance state

VA

Source file

FY2025_All_Assistance_Full_20261006.zip

Description

NOVEL 5-HT2A/MGLUR5 ANTAGONIST FOR OPIOID USE DISORDER - OPIOID OVERDOSE DEATHS CONTINUE TO BE A MAJOR PUBLIC HEALTH PROBLEM IN THE US REQUIRING IMPROVEMENTS IN TREATMENTS FOR OPIOID USE DISORDER (OUD). DESPITE CURRENT MEDICATION FOR ADDICTION TREATMENT (MAT), TREATMENT DROPOUT AND SUBSTANCE USE RECURRENCE RATES REMAIN HIGH. THUS, NOVEL THERAPEUTICS TO AUGMENT MAT TO IMPROVE TREATMENT OUTCOMES AND REDUCE OPIOID OVERDOSE DEATHS ARE NEEDED. PRIOR RESEARCH SUGGESTS THAT 5-HT2A AND MGLUR5 RECEPTOR ANTAGONISTS COULD BE USEFUL IN REDUCING IMPULSIVE RESPONSES TO DRUG CUES, IMPROVING NEGATIVE EMOTIONALITY, AND REDUCING THE OVERALL REWARDING VALUE OF REINFORCING STIMULI, AND THROUGH THESE MECHANISMS IMPROVE TREATMENT RETENTION AND REDUCE RELAPSE IN PATIENTS WITH OUD. VIVOZON INC, HAS DEVELOPED VVZ-2417- A NEW CHEMICAL ENTITY, WHICH HAS A HIGH SELECTIVITY FOR 5-HT2A AND MGLUR5 ANTAGONISM. IN PRECLINICAL STUDIES, VVZ-2471 REDUCES MORPHINE SELF-ADMINISTRATION, DRUG-INDUCED REINSTATEMENT OF MORPHINE SELF-ADMINISTRATION AFTER FORCED ABSTINENCE, AND MORPHINE WITHDRAWAL SYMPTOMS PRECIPITATED BY NALOXONE. IN HUMAN STUDIES, SINGLE AND MULTIPLE ASCENDING DOSE STUDIES SHOWED VVZ-2471 TO BE SAFE IN HEALTHY CONTROLS WITH THE MOST COMMON ADVERSE EVENTS BEING DIZZINESS AND GASTROINTESTINAL SYMPTOMS, WITH NO SERIOUS ADVERSE EVENTS. TAKEN TOGETHER, PRECLINICAL, AND EARLY CLINICAL SAFETY DATA ALL SUPPORT FURTHER RESEARCH ON VVZ-2471 AS A POTENTIAL TREATMENT FOR OUD. THIS PROJECT, WHICH IS A COLLABORATION BETWEEN VIVOZON INC AND VIRGINIA COMMONWEALTH UNIVERSITY, WILL ESTABLISH PRELIMINARY SAFETY AND EARLY EFFICACY DATA TO SUPPORT VVZ-2471 PHASE II CLINICAL TRIALS FOR A FUTURE NDA WITH THE INDICATION AS AN ADJUNCTIVE TREATMENT WITH BUPRENORPHINE FOR OUD. UG3: SPECIFIC AIM 1. ESTABLISH THE PRECLINICAL SAFETY OF VVZ-2471 WHEN ADMINISTERED IN COMBINATION WITH OPIOIDS. MILESTONE 1. COMPLETION OF SAFETY AND DRUG-DRUG INTERACTION (DDI) STUDY IN RODENTS FOR VVZ-2471 WHEN ADMINISTERED IN COMBINATION