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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 IIProduct 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:
OTO-313 did show a higher response rate than placebo in a prospectively defined patient subgroup with tinnitus duration of less than 6 months (population studied in Phase 1/2 trial), the overall results do not support further development of OTO-313.
Lead Product(s): Gacyclidine
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2022
Details:
OTO-825, is an AAV-mediated gene therapy targeting the gap junction beta-2 (GJB2) administration rescues hearing and cochlear damage in two preclinical models of congenital hearing loss caused by GJB2 deficiency.
Lead Product(s): OTO-825
Therapeutic Area: Genetic Disease Product Name: OTO-825
Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2022
Details:
Patients were randomized 1:1 to a single intratympanic injection of OTO-313 or placebo and are being followed for 4 months in Phase 2 trial. OTO-313, a sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine for treatment of tinnitus.
Lead Product(s): Gacyclidine
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 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 IIProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2021
Details:
OTIPRIO is a sterile, preservative-free, otic suspension of 6 percent ciprofloxacin administered as a single-dose by a healthcare professional. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed.
Lead Product(s): Ciprofloxacin
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otiprio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: ALK
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition June 03, 2021
Details:
Results demonstrate that a single administration of OTO-825 rescues hearing loss and cochlear damage in two preclinical models that represent a range of hearing loss severity caused by GJB2 deficiency.
Lead Product(s): Dexamethasone
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otividex
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2021
Details:
OTO-313 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate receptor antagonist gacyclidine. Phase 2 study design based on successful Phase 1/2 trial including use of Tinnitus Functional Index responder analysis for primary efficacy endpoint.
Lead Product(s): Gacyclidine
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2021
Details:
The Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease did not achieve the primary endpoint, which was the count of definitive vertigo days in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat population using the Negative Binomial Model.
Lead Product(s): Dexamethasone
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otividex
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2021
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