This Project Grant award of $702,965 was provided by the National Institute on Drug Abuse (NIDA) under the federal Drug Use and Addiction Research Programs (CFDA 93.279). The purpose of the award is to conduct a pilot mechanistic study to evaluate the potential of the drug semaglutide, a glucagon-like peptide receptor agonist (GLP-1RA), as a treatment for cocaine use disorder (CUD). The 4-year study, which will run from June 2025 to February 2029, will assess semaglutide's impact on key...
This $319,547 project grant awarded on September 15, 2023 by the National Institute on Drug Abuse (NIDA) under the Drug Abuse and Addiction Research Programs (CFDA 93.279) supports Afasci, Inc.'s research and development of a novel treatment for cocaine use disorder (CUD). The project will investigate the effects of Afasci's investigational new drug AFA-281, which inhibits both the T-type Cav3 ion channels and soluble epoxide hydrolase, on reducing cocaine-seeking behavior and hyperlocomotion in...
The National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), awarded a $400,000 Project Grant to Iontx Inc., a woman-owned small business located in Friendswood, Texas. The goal of this 12-month grant, which runs from May 15, 2025 to April 30, 2026, is to conduct structure-activity relationship (SAR) analysis and optimization of a novel small-molecule compound, 5788, that enhances the FGF13/NAV1.6 complex. This compound has shown potential to...
This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), is focused on advancing NR4A1 as a novel target for the treatment of cocaine use disorder. The $405,230 award to Rafias LLC, a woman-owned small business in Philadelphia, aims to identify and optimize lead compounds that activate the NR4A1 receptor, which has been shown to suppress cocaine reward behavior in mice. The key products and services to be...
This federal Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), is funding the development of a novel epigenetic regulator as a potential treatment for opioid use disorder (OUD). The grantee, Epivario Inc., a for-profit biotechnology research organization, will screen a new class of ACSS2 inhibitors and evaluate their efficacy in preclinical animal models of OUD. Specifically, the $275,253 award will support...
The National Institute on Drug Abuse (NIDA), under the federal Drug Use and Addiction Research Programs (CFDA 93.279), has awarded a $23,579,701 Cooperative Agreement to Ensysce Biosciences, Inc. to support the clinical development of PF614-MPAR, an opioid product with oral overdose protection. The key objectives of this project are to continue the clinical development of PF614-MPAR, a combination product of a trypsin-activated abuse protection (TAAP) oxycodone prodrug and a trypsin inhibitor...
This $385,000 Project Grant award from the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279) aims to advance integrated treatment for co-occurring opioid use disorder (OUD) and alcohol use disorder (AUD) in real-world settings. The key objectives are to: Assess the effectiveness of integrated treatment approaches, including first-line medications and glucagon-like peptide-1 receptor agonists (GLP-1 RAs), for patients with co-occurring OUD...
This federal Cooperative Agreement award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $4,710,576.00 to Mebias Discovery Inc. to develop a new chemical entity, MEB-1170, as a maintenance medication for the treatment of opioid use disorder (OUD). The project aims to complete preclinical studies in rodents and non-human primates to evaluate the efficacy of MEB-1170 in reducing fentanyl self-administration and its safety...
This federal Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $634,048 to The University of Kentucky Research Foundation to conduct a human laboratory study evaluating the efficacy of the drug troriluzole as a treatment for methamphetamine use disorder (MUD), both alone and in cases of co-occurring MUD and opioid use disorder (OUD). The study aims to translate previous preclinical findings on...
This Cooperative Agreement award, provided by the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279), aims to develop and validate a novel patient-reported outcome measure of substance-related consequences for use in substance use disorder (SUD) treatment trials. The $352,064 award, effective from August 1, 2025 to July 31, 2027, will be executed by the Mclean Hospital Corporation, a non-profit psychiatric teaching hospital affiliated with...
PDE7 INHIBITOR FOR THE TREATMENT OF COCAINE USE DISORDER - ABSTRACT THE GOAL OF THIS PROJECT IS TO ADVANCE TO THE CLINIC AN ORAL DRUG CANDIDATE TO TREAT COCAINE USE DISORDER (CUD). AN ESTIMATED 1.3M PERSONS IN THE US HAVE CUD, AND MORE THAN 19K PEOPLE DIE EACH YEAR FROM OVERDOSES INVOLVING COCAINE. THERE ARE NO APPROVED DRUG TREATMENTS FOR COCAINE ABUSE. MOST INDIVIDUALS SEEKING TREATMENT FOR CUD RECEIVE ONLY PSYCHOSOCIAL TREATMENTS THAT HAVE HIGH TREATMENT DROPOUT AND RELAPSE RATES. OMEROS DEVELOPED A NOVEL CLASS OF SMALL MOLECULES THAT SELECTIVELY INHIBIT PHOSPHODIESTERASE 7 (PDE7). COCAINE INHIBITS THE REUPTAKE OF DOPAMINE AND OTHER MONOAMINE NEUROTRANSMITTERS, ELICITING DOPAMINE SURGES THAT IS CONSIDERED THE PRIMARY MECHANISM THROUGH WHICH COCAINE EVOKES REWARD AND INITIATES ADDICTION. THE PDE7 CLASS OF INHIBITORS IS THOUGHT TO RESTORE THE PHYSIOLOGICAL DOPAMINE PHASIC-TO-TONIC RATIO THAT IS ALTERED BY CHRONIC EXPOSURE TO DRUGS OF ABUSE TO REDUCE CRAVING. THE OMEROS PDE7 INHIBITOR, OMS182399, IS ORALLY AVAILABLE WITH PHARMACOKINETICS THAT SUPPORTS ONCE-DAILY DOSING. OMS182399 REDUCES COCAINE SEEKING IN PRECLINICAL ANIMAL MODELS OF CUD AND IS SAFE AND TOLERABLE IN HEALTHY VOLUNTEERS. THE OBJECTIVE OF THIS U01 PROJECT IS TO ADVANCE OMS182399 TOWARD CLINICAL TRIALS FOR CUD BY COMPLETING REQUIRED PRECLINICAL INTERACTION/ TOXICOLOGY STUDIES AND THEN PERFORMING A CLINICAL STUDY TO TEST THE SAFETY, TOLERABILITY, PK AND PRELIMINARY EFFICACY OF OMS182399 IN PERSONS WITH CUD. THIS PROJECT MEETS THE GOALS OF PAR-19-327 IN THAT IT ACCELERATES THE DEVELOPMENT OF A NOVEL ORAL DRUG CANDIDATE TO TREAT CUD, FOR WHICH THERE ARE NO APPROVED DRUGS. AIM 1 IS TO CONDUCT IND-ENABLING INTERACTION/TOXICOLOGY STUDIES OF OMS182399 IN RATS AND NON-HUMAN PRIMATES. ALTHOUGH PRIOR STUDIES SHOWED THAT OMS182399 IS SAFE IN RATS, CYNOMOLGUS MONKEYS AND PEOPLE, THE FDA REQUIRES DRUG INTERACTION SAFETY STUDIES TO ENSURE THAT IT IS SAFE IN PEOPLE WITH CUD WHO MAY USE COCAINE WHILE IN TREATMENT. AIM 2 IS TO PREPARE AND SUBMIT AN IND APPLICATION FOR THE CLINICAL TRIAL PROPOSED IN AIM 3. OMEROS WILL WRITE AND SUBMIT AN INVESTIGATIONAL NEW DRUG (IND) APPLICATION WITH THE FDA TO TEST OMS182399 FOR SAFETY, TOLERABILITY, PK AND PRELIMINARY EFFICACY DURING CONCURRENT COCAINE ADMINISTRATION IN PERSONS WITH CUD. AIM 3 IS TO CONDUCT A 2-WEEK RANDOMIZED, SINGLE DOSE, DOUBLE BLIND, PARALLEL GROUP, IN- PATIENT CLINICAL STUDY TO COMPARE THE SAFETY, TOLERABILITY, PK AND PRELIMINARY EFFICACY OF ORAL OMS182399 TO PLACEBO (VEHICLE SOLUTION) IN THE TREATMENT OF ADULTS WITH CUD WHO RECEIVE CONCURRENT INTRAVENOUS COCAINE. OUTCOMES WILL BE TOLERABILITY, SAFETY, SUBJECTIVE PRELIMINARY EFFICACY MEASURES AND PHARMACOKINETICS. SUCCESSFUL COMPLETION OF THIS PROJECT WILL LEAD TO A FUTURE PHASE II CLINICAL PROOF-OF-CONCEPT STUDY TO ADVANCE OMS182399 TOWARD FDA APPROVAL FOR CUD, WHICH WILL HAVE VAST PUBLIC HEALTH IMPLICATIONS.