Gateway Biotechnology, Inc.
Gateway Biotechnology is dedicated to developing first-in-class drug therapies for tinnitus and hearing disorders. Founded in 2011 by Drs. Jianxin Bao, Rick Chole, and Philip Perez, the company aims to translate basic scientific discoveries into novel therapies. With a focus on addressing the unmet needs of tinnitus patients, Gateway Biotechnology is advancing innovative solutions like GW-TT2 and GW-TT5 to provide effective treatments for this debilitating condition.
Industries
Nr. of Employees
small (1-50)
Gateway Biotechnology, Inc.
St Louis, Missouri, United States, North America
Products
Intranasal small-molecule therapy for recent-onset tinnitus
A drug product formulation delivered via the intranasal route designed to treat tinnitus that developed within the last two years, including cases associated with Ménière’s disease; demonstrated preclinical efficacy in noise-induced mouse models.
Gene therapy program for severe debilitating tinnitus
A preclinical gene therapy program aimed at treating severe, debilitating tinnitus; currently under preclinical development with plans toward clinical translation.
Intranasal small-molecule therapy for recent-onset tinnitus
A drug product formulation delivered via the intranasal route designed to treat tinnitus that developed within the last two years, including cases associated with Ménière’s disease; demonstrated preclinical efficacy in noise-induced mouse models.
Gene therapy program for severe debilitating tinnitus
A preclinical gene therapy program aimed at treating severe, debilitating tinnitus; currently under preclinical development with plans toward clinical translation.
Services
Preclinical efficacy screening in tinnitus models
Behavioral and efficacy screening of small molecules and gene therapies using established animal models to identify lead compounds for clinical development.
Biomarker assay development and molecular profiling
Development of blood-based miRNA and metabolomic assays and workflows to support subtype classification and clinical trial stratification.
Functional biomarker acquisition and analysis
Collection and analysis of audiometric, electrophysiological and imaging data (pure tone audiometry, ABR, ECochG, EEG, fMRI) to characterize functional features of tinnitus.
AI-driven data integration and subtype prediction
Application of AI models to integrate psychoacoustic, molecular, electrophysiological and imaging data for prediction of tinnitus subtypes.
Regulatory strategy and IND preparation
Planning and execution of regulatory interactions including pre-IND engagement and development strategies aligned with regulatory pathways such as 505(b)(2).
Preclinical efficacy screening in tinnitus models
Behavioral and efficacy screening of small molecules and gene therapies using established animal models to identify lead compounds for clinical development.
Biomarker assay development and molecular profiling
Development of blood-based miRNA and metabolomic assays and workflows to support subtype classification and clinical trial stratification.
Functional biomarker acquisition and analysis
Collection and analysis of audiometric, electrophysiological and imaging data (pure tone audiometry, ABR, ECochG, EEG, fMRI) to characterize functional features of tinnitus.
AI-driven data integration and subtype prediction
Application of AI models to integrate psychoacoustic, molecular, electrophysiological and imaging data for prediction of tinnitus subtypes.
Regulatory strategy and IND preparation
Planning and execution of regulatory interactions including pre-IND engagement and development strategies aligned with regulatory pathways such as 505(b)(2).
Expertise Areas
- Tinnitus drug development
- Gene therapy R&D for auditory indications
- Preclinical animal modeling and behavioral assays
- Biomarker discovery and molecular assay development
Key Technologies
- Intranasal drug delivery
- Gene therapy vector technologies
- Animal behavioral models for tinnitus
- miRNA profiling