US-based Otologic Pharmaceutics (OPI) has started Phase I clinical trial of its lead product candidate HNPN-1010 to treat acute sensorineural hearing loss.
The company is developing NHPN-1010 to treat noise-induced hearing loss (NIHL) and Cisplatin-induced hearing loss (CIHL).
The trial will determine the safety, tolerability and pharmacokinetic (PK) profile of oral administration of HPN-07 alone and in combination with N-acetylcysteine (NAC) in single doses in healthy male and female subjects between 18 and 55 years of age.
Around 32 subjects will be enrolled in four cohorts of the single-centre, randomised, placebo-controlled, double-blind, single ascending dose escalation Phase I trial.
OPI is focused on developing and commercialising new pharmacological solutions and approaches to treat hearing disorders, including acute sensorineural hearing loss due to noise or ototoxic drug exposure, tinnitus and the restoration of hearing by regeneration of cochlear hair cells.
OPI CEO Clayton Duncan said: "Initiation of clinical testing on NHPN 1010 is a major development milestone for OPI.
"We have completed the dosing of the first of four cohorts of patients, and based on this progress, we anticipate top-line data in Q1 of 2015. This puts OPI on track to initiate Phase II clinical trials in NIHL or CIHL in 2015."
OPI is part of the Accele BioPharma biotechnology accelerator, having closed a Series A financing of $4.1m earlier in 2014 to fund clinical development activities.
In the trial, the first three cohorts will receive sequential ascending dosing levels of HPN-07 from between 500mg and 1,500mg, with the fourth cohort receiving the highest tolerated dose of HPN-07 plus 1,200mg NAC (NPHN-1010).
The trial's primary endpoint is to establish the safety and tolerability of HPN-07 and of NHPN-1010 (HPN-07 plus NAC).
The company said that PK analysis will enable a preliminary determination of the relationship between dose and the time course of the drug concentration in the body.