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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 Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Pipeline Therapeutics"},{"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-413 in Patients with Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Undisclosed","graph2":"Otonomy"},{"orgOrder":0,"company":"Pipeline Therapeutics","sponsor":"Franklin Templeton","pharmaFlowCategory":"D","amount":"$80.0 million","upfrontCash":"Undisclosed","newsHeadline":"Pipeline Therapeutics Completes $80 Million Series C Financing","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Pipeline Therapeutics"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Initiates Expansion of Phase 1\/2 Clinical Trial for OTO-413 in Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Undisclosed","graph2":"Otonomy"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Reports Positive Top-Line Results from Phase 2a Clinical Trial of OTO-413 in Patients with Hearing 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"}]
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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