OTO-413 / Otonomy - LARVOL DELTA

Single Intratympanic Injection of Proprietary Brain-Derived Neurotrophic Factor (OTO-413) in Subjects with Speech-in-Noise Hearing Impairment: a Randomized, Dose Escalating, Double-Blind, Placebo-Controlled Phase 1/2 Study. (PubMed, J Assoc Res Otolaryngol) - P1/2 | "This exploratory study demonstrated that a single intratympanic injection of OTO-413 was safe and well tolerated and provided evidence for a SIN hearing treatment benefit of 0.3 mg OTO-413."

Clinical • Journal • P1/2 data • Otorhinolaryngology • BDNF

"When will clinical trials for oto-413 begin? Is crowdfunding bad for fundraising?" (,@ajisonso)

Clinical

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment (clinicaltrials.gov) - P1/2 | N=110 | Completed | Sponsor: Otonomy, Inc. | Active, not recruiting ➔ Completed | N=70 ➔ 110 | Trial completion date: Jun 2022 ➔ Sep 2022 | Trial primary completion date: Jun 2022 ➔ Sep 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Otorhinolaryngology

A neurotrophic approach to treating hearing loss: Translation from animal models to clinical proof-of-concept. (PubMed, J Acoust Soc Am) - "A phase 1/2 clinical trial with OTO-413 has provided initial proof-of-concept for improved speech-in-noise hearing performance in subjects with hearing loss. Key considerations for the design of this clinical study, including aspects of the speech-in-noise assessments, are discussed."

Journal • Preclinical • Otorhinolaryngology • BDNF

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment (clinicaltrials.gov) - P1/2 | N=70 | Active, not recruiting | Sponsor: Otonomy, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Otorhinolaryngology

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment (clinicaltrials.gov) - P1/2; N=70; Recruiting; Sponsor: Otonomy, Inc.; Active, not recruiting ➔ Recruiting; N=40 ➔ 70; Trial completion date: Oct 2020 ➔ Jun 2022; Trial primary completion date: Oct 2020 ➔ Jun 2022

Clinical • Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Otorhinolaryngology

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment (clinicaltrials.gov) - P1/2; N=40; Active, not recruiting; Sponsor: Otonomy, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Otorhinolaryngology

OTO-413 in Subjects With Speech-in-Noise Hearing Impairment (clinicaltrials.gov) - P1/2; N=40; Recruiting; Sponsor: Otonomy, Inc.; N=30 ➔ 40

Clinical • Enrollment change