Gateway Biotechnology
Clinical-stage biotechnology company developing drug and gene therapy approaches for hearing disorders, focused on noise-induced hearing loss, recent-onset tinnitus, and chronic debilitating tinnitus. The organization advances programs through preclinical development and early-stage clinical trials, leveraging intranasal formulations, repurposed drugs, new chemical entities, chemogenetic gene therapy, rodent behavioral models, and regulatory engagement with the U.S. FDA.
Industries
N/A
Nr. of Employees
small (1-50)
Products
Oral zonisamide formulation for prevention of noise-induced hearing loss
An oral formulation repurposing a T-type calcium channel blocker to prevent acute noise-induced hearing loss; previously evaluated in a randomized, double-blind trial and advanced to Phase 2 clinical development in collaboration with an academic medical center.
Intranasal formulation for recent-onset tinnitus and inner-ear delivery
A patented intranasal formulation of an L-type calcium channel blocker developed to deliver higher brain and inner-ear concentrations relative to oral dosing, intended to enable lower doses, faster onset, and reduced systemic side effects; completing preclinical safety with plans for human studies.
AAV-based chemogenetic gene therapy for chronic tinnitus
A preclinical gene therapy program using AAV delivery of chemogenetic receptors to inhibitory neurons in a targeted brain nucleus to suppress tinnitus percepts upon activation by orally administered ligands; phase 1 clinical study is in development.
New chemical entity small-molecule program for tinnitus
Discovery-stage small molecule program (new chemical entity) undergoing animal PK/PD and efficacy studies to evaluate potential therapeutic effects on tinnitus.
GW-TT2
A novel nasal formulation of an FDA-approved drug for targeted drug delivery to the brain to provide relief for recent onset tinnitus.
GW-TT1
An oral formulation of zonisamide designed to prevent noise-induced hearing loss (NIHL) by blocking T-type calcium channels.
Oral zonisamide formulation for prevention of noise-induced hearing loss
An oral formulation repurposing a T-type calcium channel blocker to prevent acute noise-induced hearing loss; previously evaluated in a randomized, double-blind trial and advanced to Phase 2 clinical development in collaboration with an academic medical center.
Intranasal formulation for recent-onset tinnitus and inner-ear delivery
A patented intranasal formulation of an L-type calcium channel blocker developed to deliver higher brain and inner-ear concentrations relative to oral dosing, intended to enable lower doses, faster onset, and reduced systemic side effects; completing preclinical safety with plans for human studies.
AAV-based chemogenetic gene therapy for chronic tinnitus
A preclinical gene therapy program using AAV delivery of chemogenetic receptors to inhibitory neurons in a targeted brain nucleus to suppress tinnitus percepts upon activation by orally administered ligands; phase 1 clinical study is in development.
New chemical entity small-molecule program for tinnitus
Discovery-stage small molecule program (new chemical entity) undergoing animal PK/PD and efficacy studies to evaluate potential therapeutic effects on tinnitus.
GW-TT2
A novel nasal formulation of an FDA-approved drug for targeted drug delivery to the brain to provide relief for recent onset tinnitus.
GW-TT1
An oral formulation of zonisamide designed to prevent noise-induced hearing loss (NIHL) by blocking T-type calcium channels.
Expertise Areas
- Clinical trial management for otology indications
- Intranasal drug formulation and CNS/inner-ear delivery
- Gene therapy and chemogenetic neuromodulation
- Drug repurposing and new chemical entity development
Key Technologies
- Intranasal drug delivery
- AAV vector delivery
- Chemogenetics (DREADD-based neuromodulation)
- Operant behavioral tinnitus detection (SBAD)
News & Updates
Presentation on identification of functional biomarkers associated with age-related cochlear synaptopathy at ARO 48th Annual MidWinter Meeting.
Presentation focusing on disease-specific biomarker development, cochlear damage subtyping, and translational challenges in preclinical screening.
Discussion of novel small molecule and gene therapeutic approaches for tinnitus, and considerations of safety, immunogenicity, and dosing across patient populations.
Announcement of successful completion of a Type B pre-IND meeting for a lead intranasal program with FDA feedback supporting CMC, nonclinical, and clinical development and acceptance of a 505(b)(2) pathway.
Publication noting patients experiencing hearing loss in the unoperated ear after skull-based surgery and the need for protective treatments.
Peer-reviewed article on methods to reduce variability in auditory evoked potential measurements.
Presentation on identification of functional biomarkers associated with age-related cochlear synaptopathy at ARO 48th Annual MidWinter Meeting.
Presentation focusing on disease-specific biomarker development, cochlear damage subtyping, and translational challenges in preclinical screening.
Discussion of novel small molecule and gene therapeutic approaches for tinnitus, and considerations of safety, immunogenicity, and dosing across patient populations.
Announcement of successful completion of a Type B pre-IND meeting for a lead intranasal program with FDA feedback supporting CMC, nonclinical, and clinical development and acceptance of a 505(b)(2) pathway.
Publication noting patients experiencing hearing loss in the unoperated ear after skull-based surgery and the need for protective treatments.
Peer-reviewed article on methods to reduce variability in auditory evoked potential measurements.