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Otonomy

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Otonomy Reports Results from Clinical Evaluation of OTO-413 Higher Doses in Patients with Hearing Loss

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

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Otonomy Reports Positive Top-Line Results from Phase 2a Clinical Trial of OTO-413 in Patients with Hearing Loss

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

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Otonomy

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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.

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

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Pipeline Therapeutics

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Pipeline Therapeutics Completes $80 Million Series C Financing

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

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Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-413 in Patients with Hearing Loss

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

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Pipeline Therapeutics Initiates Phase 1/2a Clinical Trial of PIPE-505 in Sensorineural Hearing Loss

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

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Otonomy

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Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-313 in Patients with Tinnitus

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

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