# Development of a Commercial Platform for Discovery and Validation of Key Microbial Metabolites in CNS Disorders

> **NIH NIH R44** · SECOND GENOME, INC. · 2020 · $967,251

## Abstract

Despite a wealth of continued funding and ever emerging advancements in diagnostic and therapeutic
technologies, the burden of central nervous system (CNS) disorders remains substantial. The cost of Substance Use
Disorder (SUD) alone is estimated at > $181 billion (2002). The findings of numerous efforts tasked with identifying risk
factors and causative agents of SUD suggest that vulnerability to dependence is a complex phenotype influenced by both
genetics and environmental factors. Autism Spectrum Disorder (ASD) also appears to be largely impacted by both genetic
and environmental factors, more specifically the gut microbiome.
Recent studies have demonstrated that autism and SUD share common neural networks and molecular signaling
pathways. Several of the gene-products associated with the ASD phenotype (e.g., synaptic cell adhesion molecules in the
striatum and basal ganglia) affect synaptic transmission between neurons, which has also been implicated in the addiction
and reward system. In addition, adults afflicted with high functioning autism exhibit greater susceptibility to drug
dependence. We hypothesize that advancing the current state of knowledge regarding ASD, with particular regard to the
attributes shared with drug addiction, will inspire the conceptualization and development of novel therapeutic
interventions to correct common elements of striatal dysfunction.
Testing this hypothesis will require a validated turn-key platform enabling customers the ability to ship clinical
fecal samples from affected and unaffected subjects and receive a list of metabolites mediated by microbiome functions
and a pre-clinical (in vivo) data package deciphering the phenotypic modulation of the CNS disease. With the funding
received through this award, we will design, develop, and commercialize a robust CNS-microbiome-interplay (CMI)
platform-based service that will enable (i) elucidation of novel microbiome-mediated targets in CNS diseases, including
metabolites, proteins and peptides, (ii) pre-clinical data collection in standardized animal models, quantifying the
influence of microbial bioactive molecules, and (iii) application across a wide range of therapeutic areas, such as SUD and
ASD. The CMI platform-based service offering will allow medical and pharmaceutical pharma customers (i.e., our target
market) to rapidly define diagnostic and therapeutic targets from clinical samples and deduce pre-clinical efficacy
estimates sans investment in venture capital or complex infrastructure.

## Key facts

- **NIH application ID:** 9850227
- **Project number:** 5R44DA043954-03
- **Recipient organization:** SECOND GENOME, INC.
- **Principal Investigator:** Todd Z DeSantis
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $967,251
- **Award type:** 5
- **Project period:** 2017-07-01 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9850227

## Citation

> US National Institutes of Health, RePORTER application 9850227, Development of a Commercial Platform for Discovery and Validation of Key Microbial Metabolites in CNS Disorders (5R44DA043954-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9850227. Licensed CC0.

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