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Otologic Pharmaceutics (OPI) Initiates Phase 1 Clinical Study of NHPN-1010 for Hearing Disorders

OKLAHOMA CITY, Nov. 19, 2014 /PRNewswire/ — Otologic Pharmaceutics, Inc. (OPI) announced today the initiation of clinical testing of NHPN-1010, its lead product candidate for the treatment of acute sensorineural hearing loss. OPI is a development-stage biopharmaceutical company committed to developing and commercializing novel 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. NHPN-1010 is being developed for the treatment of noise-induced hearing loss (NIHL) and Cisplatin-induced hearing loss (CIHL).

Clayton Duncan, OPI’s CEO, stated, “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 2 clinical trials in NIHL or CIHL in 2015.” OPI is part of the Accele BioPharma biotechnology accelerator in Oklahoma City, OK, having closed a Series A financing of $4.1 million earlier this year to fund clinical development activities.

Phase 1 Safety Study of NHPN-1010 (HPN-07 plus N-acetylcysteine (NAC)) in Adult Subjects

The Phase 1 study is a single-center, randomized, placebo-controlled, double-blind, single ascending dose escalation study to 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 to healthy male and female subjects between 18 and 55 years of age. Approximately 32 subjects will be enrolled in four cohorts. The first three cohorts will receive sequential ascending dosing levels of HPN-07 from between 500 mg and 1,500 mg, with the fourth cohort receiving the highest tolerated dose of HPN-07 plus 1,200 mg NAC (NPHN-1010). The primary endpoint of this trial is to establish the safety and tolerability of HPN-07 and of NHPN-1010 (HPN-07 plus NAC). PK analysis will enable a preliminary determination of the relationship between dose and the time course of the drug concentration in the body.  More information on the study can be found at http://clinicaltrials.gov/ct2/show/NCT02259595

About Hearing Loss

The World Health Organization estimates that more than 600 million individuals worldwide suffer from some form of hearing loss. Approximately 10% of Americans (22 million people) between ages 20 and 69 already may have suffered permanent damage to their hearing from excessive noise exposure. This exposure can occur in the workplace, in recreational settings, and at home. Noise-induced hearing loss is the single largest addressable cause of hearing loss problems. Cancer therapy-induced hearing loss also is a major addressable cause of hearing loss. Hearing loss costs the US up to $56 billion per year in lost productivity, retraining and health care for the hard of hearing. Currently, no pharmaceutical treatments for hearing loss are available to patients.

About Otologic Pharmaceutics, Inc.

OPI’s lead product, NHPN-1010, an oral treatment for Acute Hearing Loss, is scheduled to enter clinical trials in 2014. Extensive pre-clinical research, done collaboratively through OMRF and HEI supported by nearly $5.4 million from the Department of Defense, has demonstrated the potential effectiveness of NHPN-1010 to treat Acute Noise Induced Hearing Loss (NIHL) by reducing acute damage and promoting healing and recovery of the injured cochlea. NIHL is a major cause of disability in the military and for workers in certain industry settings, including oil and gas extraction and refining, manufacturing, farming and others. OPI also plans to initiate studies on the use of NHPN-1010 to treat Cisplatin Induced Hearing Loss (CIHL). Cisplatin, a widely used cancer treatment, causes marked hearing loss in over 75% of the nearly 700000 patients treated each year.

See www.otologicpharmaceutics.com for additional information about NHPN-1010.

About Accele Biopharma, Inc.

Accele Biopharma (“Accele”) and Accele Venture Partners 1 LP, a related special purpose venture fund, were formed to create a capital-efficient mechanism to identify, finance and manage groundbreaking, early-stage life science technologies that have the potential to dramatically improve human healthcare, have strong commercial promise and have the potential for generating early proof of concept data. To achieve this goal Accele has assembled an experienced management team, a group of sophisticated investors, a nationally recognized advisory board, leading research facilities and the broad scientific expertise necessary to evaluate and manage such opportunities.

Founded in 2011, Accele is located on the Oklahoma Health Sciences University Campus in Oklahoma City. For more information on Accele Biopharma, please visit www.accelebio.com.

CONTACTS:

Clayton I Duncan
Accele Biopharma Inc.
(405) 319-8165
cduncan@accelebio.com

Justin Briggs
Accele Biopharma Inc.
(405) 319-8166
jbriggs@accelebio.com