Otologic Pharmaceutics, Inc. successfully completes Phase I trial to treat Noise Induced Hearing Loss

December 1, 2015

Otologic Pharmaceutics, Inc. (OPI), a development-stage biopharmaceutical company committed to developing and commercializing novel pharmacological solutions and approaches to treat hearing disorders, announced the successful completion of single and multi-dose Phase I studies for its lead product, NHPN-1010, in healthy volunteers.

NHPN-1010 is an oral, fixed dose combination of two antioxidant molecules, HPN-o7 and n-acetylcysteine (NAC). The drug is designed for the treatment of Noise Induced Hearing Loss (NIHL). NHPN-1010 was developed in partnership with The Hough Ear Institute (HEI), a non-profit 501c3 organization aimed at the discovery of innovative technologies to improve hearing and balance.

“We are enthusiastic about the positive safety and pharmacokinetic results of the single and multi-dose Phase I trials,” said Richard Gammans, Ph.D., COO of OPI. “This product has the potential to positively impact the lives of millions of people worldwide. The sext step is to plan for a Phase II trial of NHPN-1010.”

NHPN-1010 was examined in a randomized, double-blind, placebo-controlled Phase I study for safety, tolerability, and pharmacokinetics in single and multi-dose administrations. The initial aspect of the study used a single ascending dose method to determine the maximum tolerated dose (MTD) of HPN-07, as well as examining the MTD of HPN-07 in combination with a single fixed dose of NAC. All 32 of the subjects tested tolerated the drug well, with all subjects completing the study protocol. Following this, NHPN-1010 was evaluated in both enteric coated and uncoated forms in a fixed dose over 14 consecutive days. All 20 of the subjects tested tolerated the drug well, with all subjects completing the study protocol.

Based on these findings, OPI has begun preparations for a Phase 2 clinical trial in patients with hearing disorders. Several hearing disorders are being evaluated for inclusion in the study to test the efficacy of NHPN-1010, with the goal of gauging the drugs ability to promote healing and recovery of the cochlea.

About Hearing Loss

The World Health Organization (WHO) estimates that more than 360 million individuals worldwide suffer from disabling hearing loss, of which 32 million are children. The WHO also estimates that 1.1 billion people between the ages of 12 and 35 years are at risk of Noise Induced Hearing Loss (NIHL). Approximately 10% of Americans (22 million people) between ages 20 and 69 years 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. NHIL is the single largest addressable cause of hearing loss problems. According to the Department of Defense and the Department of Veterans Affairs, the two most frequent service-connected disabilities in the military are related to hearing disorders, with 1.1 million Veterans living with 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.

About Otologic Pharmaceutics, Inc.

The innovative approach of Otologic Pharmaceutics, Inc. (OPI) to hearing loss therapeutics has lead to the successful completion of single and multi-dose Phase 1 trials by OPI’s lead product, NHPN-1010, a treatment for acute sensorineural hearing loss. As a treatment for Noise Induced Hearing Loss (NIHL) and tinnitus, NHPN-1010 has shown potential effectiveness. NIHL affects a wide range of people, from the military to industry workers in multiple settings. Other OPI product candidates are being studied for use in treating chronic hearing loss through the regeneration of sensory hair cells. Hearing loss and loss of balance are commonly caused by the loss of sensory hair cells, which can result from exposure to diverse factors, including toxins, infection, trauma, or ageing. Once lost, hair cells do not spontaneously regenerate in mammals, resulting in permanent loss of hearing and balance.

About The Hough Ear Institute

The Hough Ear Institute (HEI) is a non-profit 501c3 organization dedicated to improving hearing and balance of people worldwide. Their mission is the discovery and implementation of advanced technologies, through research, education, and humanitarian efforts, to achieve the dream “that all who have ears will hear.”