Monthly Archives: September 2015
Otologic Pharmaceutics, Inc. (OPI) announced today that it has entered into an exclusive license agreement with The Hough Ear Institute (HEI) for the development and worldwide commercialization of technology to restore sensory hair cells in the inner ear. 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 aging. Once lost, hair cells do not spontaneously regenerate in mammals, resulting in permanent hearing and balance impairments. HEI’s technology involves the use of small-interfering nucleic acids and small molecules to regenerate lost hair cells in the cochlea. Chronic, age-related hearing loss (presbycusis) affects hundreds of millions of people worldwide, and there are currently no approved treatments. The International Action on Hearing Loss estimated the market for presbycusis to be an untapped $7 billion annually.
Under the terms of the licensing agreement, OPI has acquired the rights to develop and commercialize the hearing regeneration technology worldwide. In return for these rights, HEI will receive upfront and milestone payments, as well as royalties on sales. Other terms of the deal were not disclosed.
“We are proud of the progress at HEI in pursuing breakthrough fundamental research to restore hair cells in patients, a goal that until recently was thought unobtainable,” said Richard D. Kopke, MD, FACS, Chief Executive Officer of Hough Ear Institute. “Our studies have demonstrated that our small molecule and small-interfering nucleic acid approach is successful in hair cell regeneration in the cochlea. A natural next step has been to bring this technology to a science-driven pharmaceutical company, such as OPI, that can advance this promising approach into clinical testing and commercialization. We look forward to the further advancement of these efforts.”
“This agreement is evidence of OPI’s commitment to developing important, novel treatments for hearing loss,” commented Clayton Duncan, OPI’s CEO. “Dr. Kopke’s approach has shown compelling potential in early-phase development, and based on these findings, OPI is pursuing additional preclinical testing of this approach in preparation for the initiation of clinical trials in humans in late 2017.” Outlining the scope for OPI looking ahead, Mr. Duncan added, “OPI now has a robust pipeline in this field encompassing both otoprotection and regeneration drug candidates. We are initiating a Phase 1b safety and pharmacokinetics trial for our candidate otoprotectant formulation, an oral, fixed-dose combination of two antioxidant molecules HPN-07 plus n-acetylcysteine (NAC). Next, HPN-07 plus NAC will enter a Phase 2 trial next year for the treatment of noise-induced hearing loss. The otoprotection and regeneration programs complement each other well, and the combined programs could mean real advancements in treating acute – and now chronic – hearing loss.”
About Hearing Loss
The World Health Organization estimates that more than 600 million individuals worldwide suffer from some form of hearing loss with 300 million having disabling hearing loss. Approximately 10% of Americans (22 million people) between ages 20 and 69 may already 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 deafness. Hearing loss costs the U.S. up to $56 billion per year in lost productivity, retraining and health care for the hearing impaired. Currently, no pharmaceutical treatments for hearing loss are approved for treatment.
About The Hough Ear Institute
HEI is a non-profit 501c3 organization that is committed to the process of discovery and implementation of new ways to improve hearing and balance in people worldwide. At HEI we are pursuing the dream that “all who have ears will hear.” To this end, HEI’s focus is on curing deafness worldwide, one patient, one disease at a time, through research, education, and humanitarian efforts. For more information, please visit www.houghear.org.
About Otologic Pharmaceutics, Inc.
OPI develops novel therapeutics for hearing loss. OPI’s lead product, an oral fixed-dose combination of HPN-07 and NAC for treatment of acute sensorineural hearing loss, is scheduled to enter Phase 2 clinical trials in 2016 in Noise-Induced Hearing Loss (NIHL) and tinnitus. Extensive preclinical research, done collaboratively through Oklahoma Medical Research Foundation (OMRF) and HEI and supported by nearly $5.4 million from the Department of Defense, has demonstrated the potential effectiveness of an oral, fixed-dose combination of HPN-07 plus n-acetylcysteine (NAC) to treat 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 is also developing product candidates for the regeneration of hair cells and restoration of hearing function in chronic, age-related hearing loss.
See www.otologicpharmaceutics.com for additional information.