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[{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Reports Positive Top-Line Results from Phase 1\/2 Clinical Trial of OTO-313 in Patients with Tinnitus","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Otonomy"},{"orgOrder":0,"company":"Pipeline Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pipeline Therapeutics Initiates Phase 1\/2a Clinical Trial of PIPE-505 in Sensorineural Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New 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Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Otonomy"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Reports Results from Clinical Evaluation of OTO-413 Higher Doses in Patients with Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Otonomy"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Receives European Orphan Drug Designation for Lead Gene Therapy Candidate DB-OTO","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Decibel Therapeutics"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Regeneron Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Announces Approval of Clinical Trial Application by the Spanish Agency of Medicines and Medical Devices (AEMPS) to Initiate Clinical Development of Lead Gene Therapy Candidate DB-OTO","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene 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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, monogenic hearing loss.
Lead Product(s):
DB-OTO
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: DB-OTO
Highest Development Status: Phase I/ Phase II
Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator:
Regeneron Pharmaceuticals
Deal Size: $213.0 million
Upfront Cash: $213.0 million
Deal Type: Acquisition
August 09, 2023
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.
Lead Product(s):
DB-OTO
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: DB-OTO
Highest Development Status: Phase I/ Phase II
Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator:
Regeneron Pharmaceuticals
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 12, 2023
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.
Lead Product(s):
DB-OTO
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: DB-OTO
Highest Development Status: Phase I/ Phase II
Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 30, 2023
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.
Lead Product(s):
OTO-413
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: OTO-413
Highest Development Status: Phase I/ Phase II
Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
October 13, 2022
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.
Lead Product(s):
Brain-Derived Neurotrophic Factor
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: OTO-413
Highest Development Status: Phase I/ Phase II
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 20, 2022
Details:
OTO-413 demonstrated a higher proportion of responders than placebo based on multiple speech-in-noise hearing tests in dose escalation efficacy cohort.
Lead Product(s):
Brain-Derived Neurotrophic Factor
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: OTO-413
Highest Development Status: Phase I/ Phase II
Product Type: Undisclosed
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 15, 2021
Details:
Pipeline Therapeutics plans to use the proceeds to advance its development candidates PIPE-505, in patients with sensorineural hearing loss, and PIPE-307, in patients with multiple sclerosis.
Lead Product(s):
PIPE-505
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: PIPE-505
Highest Development Status: Phase I/ Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Franklin Templeton
Deal Size: $80.0 million
Upfront Cash: Undisclosed
Deal Type: Series C Financing
February 11, 2021
Details:
Otonomy believes that these higher responder rates for OTO-413 compared to placebo at two consecutive time points across multiple SIN tests demonstrates therapeutic activity and supports continued development of OTO-413 for the treatment of hearing loss.
Lead Product(s):
Brain-Derived Neurotrophic Factor
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: OTO-413
Highest Development Status: Phase I/ Phase II
Product Type: Undisclosed
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 17, 2020
Details:
PIPE-505 is the first small molecule developed specifically for the treatment of sensorineural hearing loss (SNHL) associated with speech-in-noise impairment.
Lead Product(s):
PIPE-505
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: PIPE-505
Highest Development Status: Phase I/ Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
July 23, 2020
Details:
The trial achieved its objectives by demonstrating a positive clinical signal for OTO-313 based on a TFI responder analysis, with a favorable safety profile.
Lead Product(s):
Gacyclidine
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: OTO-313
Highest Development Status: Phase I/ Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
July 06, 2020