Lead Product(s) : DB-OTO
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
DB-OTO Results Show Normal Hearing Restoration in a Child with Genetic Deafness
Details : DB-OTO is an investigational gene therapy aimed at restoring hearing for individuals with congenital otoferlin gene-related hearing loss.
Brand Name : DB-OTO
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
May 08, 2024
Lead Product(s) : DB-OTO
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : AAV-AQP1
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Sanofi
Deal Size : $30.0 million
Deal Type : Financing
Details : Sanofi will receive a right of first negotiation for the use of MeiraGTx’s Riboswitch gene regulation technology for certain Immunology and Inflammation and CNS targets, including AAV-AQP1, a gene therapy for xerostomia caused by Sjogren's syndrome.
Brand Name : AAV-AQP1
Molecule Type : Large molecule
Upfront Cash : Undisclosed
October 30, 2023
Lead Product(s) : AAV-AQP1
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase I/ Phase II
Sponsor : Sanofi
Deal Size : $30.0 million
Deal Type : Financing
Lead Product(s) : DB-OTO
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : DB-OTO is an investigational cell-selective, adeno-associated virus (AAV) gene therapy designed to provide durable, physiological hearing to individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene.
Brand Name : DB-OTO
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
October 26, 2023
Lead Product(s) : DB-OTO
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : DB-OTO
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Regeneron Pharmaceuticals
Deal Size : $213.0 million
Deal Type : Acquisition
Details : Through the acquisition, Regeneron will strengthen its gene therapy and heraing loss programs by gaining Decibel's lead candidate, DB-OTO, which is currently in Phase 1/2 and is an investigational cell-selective, AAV gene therapy to treat congenital, mon...
Brand Name : DB-OTO
Molecule Type : Cell and Gene therapy
Upfront Cash : $213.0 million
September 25, 2023
Lead Product(s) : DB-OTO
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase I/ Phase II
Sponsor : Regeneron Pharmaceuticals
Deal Size : $213.0 million
Deal Type : Acquisition
Lead Product(s) : DB-OTO
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Regeneron Pharmaceuticals
Deal Size : $213.0 million
Deal Type : Acquisition
Regeneron to Acquire Decibel Therapeutics, Strengthening Gene Therapy and Hearing Loss Programs
Details : Through the acquisition, Regeneron will strengthen its gene therapy and heraing loss programs by gaining Decibel's lead candidate, DB-OTO, which is currently in Phase 1/2 and is an investigational cell-selective, AAV gene therapy to treat congenital, mon...
Brand Name : DB-OTO
Molecule Type : Cell and Gene therapy
Upfront Cash : $213.0 million
August 09, 2023
Lead Product(s) : DB-OTO
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase I/ Phase II
Sponsor : Regeneron Pharmaceuticals
Deal Size : $213.0 million
Deal Type : Acquisition
Lead Product(s) : DB-OTO
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Regeneron Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : DB-OTO is a gene therapy product candidate designed to provide durable restoration (selectively express functional OTOF in the inner hair cells) of hearing to individuals born with profound hearing loss due to mutation of the OTOF gene.
Brand Name : DB-OTO
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
May 12, 2023
Lead Product(s) : DB-OTO
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase I/ Phase II
Sponsor : Regeneron Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : DB-OTO
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : DB-OTO is a gene therapy product candidate designed to provide durable restoration (selectively express functional OTOF in the inner hair cells) of hearing to individuals born with profound hearing loss due to mutation of the OTOF gene.
Brand Name : DB-OTO
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
March 30, 2023
Lead Product(s) : DB-OTO
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : OTO-413
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), which is a naturally occurring protein involved in neuron growth and repair.
Brand Name : OTO-413
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
October 13, 2022
Lead Product(s) : OTO-413
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Brain-Derived Neurotrophic Factor
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 40% (8 of 20) OTO-413 subjects demonstrated a clinically-meaningful improvement on at least one of the three SIN tests at both Days 57 and 85 versus 20% (2 out of 10) for placebo.
Brand Name : OTO-413
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 20, 2022
Lead Product(s) : Brain-Derived Neurotrophic Factor
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Brain-Derived Neurotrophic Factor
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Otonomy Initiates Expansion of Phase 1/2 Clinical Trial for OTO-413 in Hearing Loss
Details : OTO-413 demonstrated a higher proportion of responders than placebo based on multiple speech-in-noise hearing tests in dose escalation efficacy cohort.
Brand Name : OTO-413
Molecule Type : Undisclosed
Upfront Cash : Not Applicable
June 15, 2021
Lead Product(s) : Brain-Derived Neurotrophic Factor
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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