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Otologic Pharmaceutics Licenses Hearing Regeneration Technology from the Hough Ear Institute

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.

Synereca Pharmaceuticals Appoints Dr. Mark Corrigan to Its Board of Directors

Synereca Pharmaceuticals, Inc. (SPI), a research-stage biopharmaceutical company developing compounds that restore or increase the effectiveness of existing antibiotics against serious Gram-Negative infections, announced today the appointment of Mark H. N. Corrigan, M.D., to the Company’s Board of Directors.  Dr. Corrigan is a seasoned life sciences executive with broad operational and clinical development experience at leading pharmaceutical and biotechnology companies.

“Mark is an important addition to our Board, possessing a distinguished track record in guiding the growth of biopharma companies and advancing the successful development of novel therapeutic agents through clinical testing and FDA filing,” said Clayton Duncan, Chief Executive Officer of Synereca. We believe his background will be invaluable as we further advance our lead agents designed to restore or increase the effectiveness of existing antibiotics.” Prior to its $9.5 billion acquisition by Merck, Dr. Corrigan served on the Board of Directors of Cubist Pharmaceuticals, Chairing the Scientific and Clinical Oversight Committee.

Dr. Corrigan commented, “I’m excited to work with the leadership team at Synereca and to contribute to the development of a novel pipeline addressing the growing problem of antibiotic resistance.  The Company’s approach – potentiating the activity of existing classes of antibiotics – has demonstrated compelling, early preclinical results. I look forward to the progress of their programs toward rearming antibiotics against these difficult-to-treat pathogens.” 

Synereca’s novel potentiators have shown the ability to significantly enhance the potency of Colistin, a last-line therapy against serious Gram-Negative bacterial infections, up to 500-fold against both susceptible and multi-drug resistant strains of Acinetobacter baumannii,Pseudomonas aeruginosa, and Enterobactericeae species including Klebsiella pneumonia and E. coli. The CDC estimates there are over 2 million infections and 23,000 deaths caused by resistant bacteria each year in the U.S. Synereca’s lead program will combine a potentiator with Colistin (polymyxin E, colistimethate sodium) for the treatment of serious hospital-associated infections caused by resistant Gram-Negative bacteria, a $2.5 billion market in the U.S. alone.

Dr. Corrigan is the former President and Chief Executive Officer of Zalicus, Inc., which in 2014 merged with EPIRUS Biopharmaceuticals, a developer of biosimilar agents for global markets.  He currently serves as Chairman of EPIRUS’ Board.  Previously, Dr. Corrigan was Executive Vice President of Research and Development at the specialty pharmaceutical company Sepracor Inc., and prior to this, he spent 10 years with Pharmacia & Upjohn, most recently as Group Vice President of Global Clinical Research and Experimental Medicine.  Before entering the healthcare industry, Dr. Corrigan was in academic research at the University of North Carolina at Chapel Hill School of Medicine, where he maintains a faculty appointment as Adjunct Professor in the Psychiatry Department.  Dr. Corrigan served on the Board of Directors for Cubist Pharmaceuticals and of Avanir Pharmaceuticals prior to their acquisitions by Merck and Otsuka Holdings, respectively. Dr. Corrigan holds an M.D. from the University of Virginia and received specialty training in psychiatry at Maine Medical Center and Cornell University.

About Synereca Pharmaceuticals, Inc.

Synereca Pharmaceuticals was founded to address the growing problem of bacterial resistance to current antibiotics by developing orally active drugs that restore or increase the effectiveness of existing antibiotics. Synereca’s lead program involves compounds that potentiate the effectiveness of Colistin without enhancing toxicity. The Colistin potentiation program’s lead compound shifts the minimum inhibitory concentration (MIC) of Colistin (CMS) in multidrug resistant Acinetobacter baumannii, Klebsiella pneumonia, Psuedomonas aeruginosa, and Escherichia coli up to 500-fold in vitro and has been shown to reduce the effective dose (PD50) of Colistin in an in vivopreclinical model of infection caused by a multi-drug resistant strain of A. baumannii four-fold. Synereca’s second program stems from two decades of NIH-funded work by Dr. Scott Singleton at the University of North Carolina, Chapel Hill, focused on the inhibition of RecA, a key enzyme in bacterial DNA repair and the development and transmission of antibiotic resistance. Synereca screened over 115,000 compounds and discovered protype RecA inhibitors and compounds that potentiate the killing of a wide variety of pathogenic bacteria by a broad range of bactericidal antibiotics. Synereca has received $1.9 million in funding from Accele Venture Partners, the Oklahoma Seed Capital Fund at i2E, Inc., and various angel investors, and is a portfolio company of biotechnology accelerator Accele Biopharma. The company is headquartered in Oklahoma City, and has laboratories in OKC and North Carolina.

For additional information on Synereca, please visit www.synereca.com.

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