UG3DA058553

Development of Sigma Receptor/DAT Dual-Targeting Compounds to Treat Stimulant Use Disorder - Abstract

The growing prevalence of stimulant use disorder (STUD) in the US is a major public health concern. As of 2020, 3.2M people had STUD in the US, which exceeds the 2.7M people with opioid use disorder (OUD), and there were ~57K stimulant-related overdose deaths in 2021. In fact, stimulants are considered the "4th wave" of the overdose crisis.

In 2020, NIDA Director Nora Volkow, MD stated that "although deaths from opioids continue to command the public's attention, an alarming increase in deaths involving the stimulant drugs methamphetamine and cocaine are a stark illustration that we no longer face just an opioid crisis".

Despite substantial R&D efforts, there is no FDA-approved pharmacotherapy for the treatment of STUD – in contrast to OUD where medication-assisted treatment (MAT) is the standard of care – and there is an urgent need for such.

This UG3/UH3 proposal aims to develop SBS-518 as a first-in-class treatment for STUD. SBS-518 is a dual sigma receptor antagonist and dopamine active transport (DAT) inhibitor. We have demonstrated that SBS-518 decreases stimulant self-administration in rats, without being rewarding itself. These data support the development of SBS-518 as a novel, first-in-class treatment for STUD.

In the UG3, we will conduct a targeted lead optimization to select our lead compound (SBS-518X) and quickly move into development. We will conduct non-GMP API and drug product development, non-GLP toxicology studies, and submit for a pre-IND meeting with FDA to align on the IND-enabling program. By the end of the UG3, we will have identified our clinical candidate and conducted preliminary CMC and tox work.

In the UH3, we will conduct the IND-enabling CMC and toxicology work, submit an IND, and conduct a Phase 1 clinical trial.

In summary, we propose to develop a novel agent for STUD and bring it through a first in human clinical trial.

Sparian Biosciences

TO SUPPORT BASIC AND CLINICAL NEUROSCIENCE, BIOMEDICAL, BEHAVIORAL AND SOCIAL SCIENCE, EPIDEMIOLOGIC, HEALTH SERVICES AND HEALTH DISPARITY RESEARCH. TO DEVELOP NEW KNOWLEDGE AND APPROACHES RELATED TO THE PREVENTION, DIAGNOSIS, TREATMENT, ETIOLOGY, AND CONSEQUENCES OF DRUG ABUSE AND ADDICTION, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE LEGISLATION INTENDS THAT THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.279 - Drug Abuse and Addiction Research Programs

National Institute on Drug Abuse (NIDA) [HHS - NIH]

New York, New York 100144606 United States

Single Zip Code

Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional) (PAR-20-092)

Amendment Since initial award the total obligations have increased 139% from $2,886,286 to $6,903,733.