This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $2,916,991 to support a Phase 1B clinical trial of Myosin Therapeutics' novel therapeutic agent MT-110 for the reduction of methamphetamine use disorder (MUD). The award will fund a double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of MT-110 in individuals with MUD. The research...
This $3,287,052 Cooperative Agreement award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), aims to advance a novel immunotherapeutic compound called DRHQ through IND-enabling studies and Phase I clinical trials as a potential treatment for stimulant use disorder, specifically methamphetamine addiction. The key products and services to be delivered under this grant include: 1) Determining the optimal dose and dosing schedule...
This Cooperative Agreement awarded by the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), aims to assess the efficacy of deep transcranial magnetic stimulation (dTMS) in treating methamphetamine use disorder (MUD). The project will enroll 30 participants in an initial mechanistic trial (UG3 phase) to evaluate whether dTMS to the insula and prefrontal cortex using the H4 coil effectively modifies the neural target and reduces relapse...
This 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 troriluzole as a potential treatment for methamphetamine use disorder (MUD), both alone and in cases of comorbid MUD and opioid use disorder (OUD). The $634,048 grant will fund a human laboratory study to evaluate the reinforcing effects of intravenous methamphetamine and the ability of troriluzole, a glutamate-modulating compound, to reduce...
This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $400,000 in funding to Iontx Inc. to conduct research aimed at developing a novel medication for treating cocaine use disorder (CUD). The key objectives are to: 1) conduct structure-activity relationship (SAR) analysis and optimization of a lead compound (5788) that enhances the FGF13/NAV1.6 protein complex, which regulates neuronal activity in the...
This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $319,000 to Sano Healthcare Consultants, LLC for the development of a novel liquid methadone dispensing device and smart container system. The project aims to address key barriers in accessing medication for opioid use disorder (MOUD) by creating a low-cost, single-device solution that enables remote supervised use, telehealth, and behavioral...
This Project Grant award of $399,483 from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), aims to generate synergy between Artificial Intelligence (AI) and DNA-encoded library (DEL) technologies to identify novel polypharmacological therapeutics for substance use disorders (SUDs). The key objectives are to: 1) Screen a 125 million compound DEL library, plus an additional 1 million GPCR-focused compounds, against the OPRD1 and DRD3...
The National Institute on Drug Abuse (NIDA) awarded a $314,225 project grant under the Drug Use and Addiction Research Programs (CFDA 93.279) to the University of Washington to explore the neurobehavioral effects of concurrent opioid and methamphetamine use disorders. The study aims to 1) define the behavioral profile of dual opioid-methamphetamine use disorders using a rodent addiction model, and 2) map neural activation patterns within the cortico-basal ganglia-thalamic circuit in response...
This Project Grant award, funded by the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279), aims to discover novel small molecule therapeutics for the safe and effective treatment of opioid use disorder (OUD). The project will leverage artificial intelligence (AI) to develop an integrated drug discovery platform called M3.AI that combines target-based and phenotype-based methodologies. This platform will generate multi-cell type, multi-target...
This federal Project Grant award from the National Institute on Drug Abuse (NIDA) under the Drug Abuse and Addiction Research Programs (CFDA 93.279) provides $318,257 to Cari Health, Inc. to develop a therapeutic monitoring system (TMS) for remote medication compliance tracking of methadone treatment for opioid use disorder (OUD). The key products and services to be delivered include: 1) Integrating an electrochemical sensor, microneedle array, and data pipeline into a prototype wearable...
NEW TARGETED BDNF NANOPARTICLES FOR TREATMENT OF METH ADDICTION AND NEUROTOXICITY - METHAMPHETAMINE USE DISORDER (MUD) REPRESENTS A MAJOR CHRONIC HEALTH PROBLEM IN THE US AND ABROAD. MAGNETIC RESONANCE IMAGING (MRI) STUDIES HAVE CONSISTENTLY SHOWN STRIATAL STRUCTURAL AND FUNCTIONAL ABNORMALITIES AND COGNITIVE DEFICITS IN PATIENTS WITH MUD. LONG-TERM METHAMPHETAMINE (METH) USE IS ASSOCIATED WITH NEURODEGENERATION OF DOPAMINERGIC SYSTEM AND NEW PHARMACEUTICALS ARE REQUIRED FOR TREATMENT OF BOTH METH ADDICTION AND TOXICITY. IN SBIR PHASE 1, EXQOR DEVELOPED A NANOTECHNOLOGY PLATFORM THAT PROVIDES AN INNOVATIVE APPROACH FOR DUAL TREATMENT OF METH ADDICTION AND NEUROTOXICITY AND CONSISTS OF 3 COMPONENTS: A CLATHRIN CARRIER NANOPARTICLE (CNP) WITH ATTACHED DOPAMINE TRANSPORTER (DAT) TARGETING LIGAND (METHYLPHENIDATE OR GBR12909 OR ANTI-DAT ANTIBODY), AND BRAIN-DERIVED NEUROTROPHIC FACTOR (BDNF). CNPS SUCCESSFULLY BYPASSED THE BLOOD-BRAIN BARRIER (BBB) AND DELIVERED ADEQUATE CONCENTRATIONS OF BDNF TO NEURONS EXPRESSING DAT IN MOUSE BRAIN. THE STRIATAL BDNF CONCENTRATIONS WERE OVER 100 FOLD HIGHER THAN REPORTED IN PREVIOUS BDNF SYSTEMIC AND NASAL DELIVERY STUDIES. CNPS ALSO RESCUED STRIATAL TYROSINE HYDROXYLASE-POSITIVE FIBERS FROM HIV/TAT, METH AND COMBINED TAT/METH NEUROTOXICITY IN ITAT MOUSE MODEL OF HIV/NEUROAIDS. THE GOAL OF THIS PHASE-2 EFFORT IS TO DEMONSTRATE SAFETY AND FEASIBILITY OF OUR NOVEL BISPECIFIC CNP WITH ATTACHED METHYLPHENIDATE AND BDNF TO SUPPRESS METH SEEKING, REVERSE METH-INDUCED NEUROTOXICITY AND SUCCESSFULLY TREAT MOTOR AND MEMORY DEFICITS IN RATS EXPOSED TO METH. FIRST, WE PLAN TO MORE THOROUGHLY TEST OUR HYPOTHESIS THAT CNPS DELIVER BDNF TO THE AFFECTED BRAIN REGIONS, REVERSE NEUROTOXIC EFFECTS OF METH IN THESE REGIONS, AND IMPROVE MOTOR AND MEMORY FUNCTIONS IN RATS EXPOSED TO TOXIC DOSES OF METH. SECOND, WE ALSO PLAN TO TEST IF CNPS SUPPRESS CONTEXT-, CUE- AND METH-INDUCED REINSTATEMENT OF DRUG SEEKING IN RATS DURING 3 WEEKS OF ABSTINENCE FROM METH SELF-ADMINISTRATION. TO ACCOMPLISH OUR PHASE-2 GOALS, WE WILL EXECUTE A SERIES OF STUDIES THAT WILL ASCERTAIN NP STABILITY, BRAIN AND BODY DISTRIBUTION, SAFETY AND FUNCTIONALITY. RATS WILL BE TESTED WITH STANDARD BEHAVIORAL TESTS. FURTHER, IMMUNOHISTOCHEMISTRY AND MOLECULAR ASSAYS WILL BE USED TO EVALUATE DENSITY OF DOPAMINERGIC FIBERS, NUMBER OF DOPAMINERGIC NEURONS AND LEVELS OF DOPAMINE AND ITS METABOLITES, AND TOXICITY OF NEW CNPS. THIS RESEARCH PROJECT WILL PROVIDE NEW NONINVASIVE NANOTECHNOLOGY TOOLS FOR TREATMENT OF METH ADDICTION AND NEUROTOXICITY. THE NEW NANOTECHNOLOGY MAY BE ABLE TO TARGET AND REGENERATE DOPAMINERGIC NEURONS; BLOCK METH-INDUCED DA RELEASE; AND SUPPRESS CONTEXT, CUE AND METH-INDUCED REINSTATEMENT OF DRUG SEEKING. IT MAY PREVENT RELAPSE, PROTECT AND RESTORE BRAIN FUNCTIONS MORE QUICKLY AND COMPLETELY THAN EXISTING TREATMENT METHODS, WHILE USING MUCH LOWER THERAPEUTIC DRUG DOSES, AND CAUSING FEWER SIDE EFFECTS. THE DEVELOPMENT OF A STABLE, NONTOXIC NANOPARTICLE MAY ALSO PROVIDE A MAJOR NEW TOOL FOR RESEARCH OF BIOMARKERS IN MUD. THIS NANOTECHNOLOGY MAY SERVE AS THE BASIS FOR A NEXT GENERATION NEUROTHERANOSTIC THAT CAN SPECIFICALLY TARGET RELEVANT BRAIN SYSTEMS, AND ALSO MAY HAVE UTILITY AS AN IMAGING AGENT TO ENHANCE DIAGNOSIS AND MONITOR PROGRESSION OF THE DISEASE.