Neurotology drug developer Otonomy (NSDQ:OTIC) is expanding a Phase 1/2 trial of OTO-413 in patients who have difficulty with speech-in-noise tests. In the trial, clinical investigators administer the drug as a single intratympanic injection.
The company said that OTO-413 showed promise in improving hearing in a dose escalation efficacy cohort.
The randomized, double-blind, placebo-controlled Phase 1/2 study will be relatively small, involving approximately 30 hearing loss patients. A total of 20 people will receive OTO-413 with the remainder receiving placebo.
“We are pleased to initiate this expansion study in order to demonstrate the treatment benefit in a larger cohort of hearing loss patients, continue our evaluation of multiple speech-in-noise hearing tests, and provide important information to help us design and power a more formal Phase 2 clinical trial,” said David A. Weber, president and CEO of Otonomy, in a statement.
OTO-413 is a formulation of brain-derived neurotrophic factor (BDNF), a naturally occurring protein. Preclinical research has pointed to the promise of locally administered BDNF in promoting growth of inner hair cells and auditory nerve fibers in the cochlea.
Otonomy expects to have top-line results by mid-2022. The company will assess efficacy by using the American English Matrix phrase test, the Words-in-Noise test and the Digits-in-Noise test.
Otonomy rival Frequency Therapeutics (NSDQ:FREQ) has a Phase 2a trial involving noise-induced and sudden sensorineural hearing loss in patients aged 18 to 65. Interim data from that trial suggested that its FX-322 experimental drug is ineffective at improving stable sensorineural hearing loss. The drug had shown promise in an earlier Phase 1/2 study.
Frequency Therapeutics’ stock has dropped from a high of $55.01 per share on Feb. 19, 2021 to $9.55 on June 15.