Category Archives: Otologic

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

Accele Venture Partners Announces Series A Financing of Otologic Pharmaceutics (OPI)

Financing to Support Entry of OPI’s Lead Product Candidate – NHPN-1010 – into Clinical Testing First Half of 2014

OKLAHOMA CITY, April 3, 2014 /PRNewswire/ — Accele Venture Partners, the investing arm of life sciences accelerator Accele Biopharma, Inc., announced today that it has co-led a $4.1 million Series A private equity financing of Otologic Pharmaceutics, Inc. (OPI), a development-stage biopharmaceutical company committed to developing and commercializing novel pharmacological solutions and approaches to treat hearing disorders. Accele Venture Partners co-led the Series A with i2E, Inc., a nationally recognized private not-for-profit corporation focused on growing innovative small businesses in Oklahoma. Other investors included the Oklahoma Life Science Fund. Proceeds of the Series A financing will be used to advance the development of OPI’s lead product candidate, NHPN-1010, for the treatment of noise-induced hearing loss (NIHL), which is expected to enter Phase 1 clinical testing in the first half of 2014.

In connection with the financing Accele Biopharma’s Chairman and CEO Clayton I. Duncan has been appointed as OPI’s CEO, replacing David Karlman in this position. Additional members of the OPI senior management team include: Richard Gammans, Ph.D., also of Accele Biopharma and recently appointed to the newly created positions of OPI’s Chief Operating Officer and Head of R&D; OPI Co-Founder and Chief Medical Officer Richard Kopke, M.D.; Company Co-Founder and Chief Science Officer Robert Floyd, Ph.D., and Kelle Jones, Vice President-Finance.

Mr. Duncan stated, “Accele is dedicated to supporting groundbreaking approaches to improve human healthcare, and we believe OPI’s programs have the potential to address substantial unmet needs for patients with hearing loss. Currently, there are no FDA-approved drugs on the market for hearing loss, and OPI’s lead product candidate, combining two well-characterized compounds, has shown promising activity in reducing hearing loss in IND-enabling preclinical studies. Applications may include hearing loss experienced by individuals in a number of occupations, such as construction and manufacturing, as well as those who have served our country in military service, in addition to hearing loss associated with cancer treatments, such as cisplatin.”

Mr. Duncan added, “I am excited to join the OPI team and also am grateful for the service of David Karlman and for the progress the Company has made in advancing its lead program toward the clinic.”

Mr. Duncan has over 20 years’ experience as a biopharmaceutical CEO, heading seven biopharmaceutical companies – Synereca Pharmaceuticals, Vindica Therapeutics, Ercole Biotech, Entegrion, Incara Pharmaceuticals Corporation, Sphinx Pharmaceuticals Corporation and CRX Medical. As a CEO, Mr. Duncan has raised over $150 million in venture and public capital markets, including two successful IPOs, and has built operational biopharmaceutical companies from initiation, negotiating seven R & D collaborations with major pharmaceutical and biotech companies and profitable exits through the sale of three biopharmaceutical companies.

Dr. Gammans has managed a broad array of product development activities, including market evaluation, clinical research, biometrics, regulatory affairs and manufacturing. He has extensive experience in supporting investor relations and business development efforts and more than 30 years’ experience in all aspects of drug R&D and scientific support of marketed products. He has contributed to the development and regulatory approval of seven new molecular entities with over 50 national marketing authorizations in Western Europe and North America, including seven approved United States NDAs.

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.

About Otologic Pharmaceutics, Inc.

OPI’s lead product, HPN1010, 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 HPN1010 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 HPN1010 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.otologicpharmaceutic.com for additional information about HPN1010.

About Accele Biopharma, Inc.

Accele Biopharma (“Accele”) and Accele Venture Partners, 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.

About i2E, Inc.

With more than $40 million of investment capital under management, i2E focuses on serving companies in all phases of the business life cycle, from startups looking for their first round of capital all the way to established businesses seeking funding to expand their markets or products.

They also are helping lead new business developments into the marketplace more efficiently and more quickly while providing guidance to bring more funding to Oklahoma’s researchers and entrepreneurs.

In the past year they have launched several new initiatives that more quickly identify promising new technologies developed on state research campuses and working with new companies at the earliest stages of their development to identify a viable product and market.

The Oklahoma Bioscience Association recently became part of i2E, a development that means they will carry on the organization’s mission of supporting and enhancing the biotechnology industry in Oklahoma.

Through their proven business and venture development process, i2E turns ideas into successful enterprises.

For more information on i2E, Inc., please visit www.i2E.org.

CONTACTS:

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

Sara Seagraves
I2E Inc.
(405) 813-2403
seagraves@i2E.org