10 Oct Otonomy Enters Strategic Collaboration with AGTC to develop a novel Gene Therapy for Congenital Hearing Loss
Otonomy Inc (NASDAQ: OTIC), a biopharmaceutical company focussed on providing neurotology solutions, announced a strategic collaboration with Applied Genetic Technologies Corporation (NASDAQ: AGTC), a biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, to create, develop and commercialize an AAV-based gene therapy for treatment of hearing loss in patients with sensorineural hearing loss on account of a mutation in the gap junction protein beta 2 gene (GJB2).
The gap junction protein beta 2 gene (GJB2) is the most common cause of congenital hearing loss, and is a contributing factor to nearly 30 percent of all hearing loss cases, characterized by severe hearing loss in both the ears. As per the terms of the agreement, both the Companies will share development and commercialization costs and revenues equally and the agreement may be extended to include additional genetic hearing loss targets in the future.
Otonomy Inc (NASDAQ: OTIC)
Market Cap: $71.64M; Current Share Price: 2.33 USD
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Dr. David A. Weber, PhD, President and CEO of Otonomy commented
“As leaders in neurotology, we are pleased to add our expertise to that of the highly experienced AGTC team, leveraging what each of us does best and sharing the cost and effort to bring a novel therapeutic to patients with profound need” He further added “The addition of this gene therapy program further extends our broad, innovative pipeline across the largest market opportunities in neurotology including acquired and genetic forms of hearing loss, tinnitus, and balance disorders such as Ménière’s disease.”
The collaboration will result in the amalgamation of the capabilities, technology and expertise of AGTC, in the field of gene therapy with that of Otonomy’s extensive experience in otic drug delivery and existing infrastructure for preclinical and clinical development in neurotology as per a Company Statement.
In addition, Otonomy has also initiated a Phase 1/2 clinical trial of OTO-413, a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), in patients with hearing loss in September 2019.
Hearing impairment is a chronic disability that affects people of all age groups. Worldwide over 360 million people are affected by this condition making it the second most prevalent health issue. According to the data made available by National Institute on deafness and other communication disorders (NIDCD), an estimated 2 to 3 out of every 1000 children in the U.S are born with detectable hearing loss in one or both ears and over 15% of American adults (37.5 million) aged 18 and over report some trouble hearing. The Hearing health foundation statistics place this number at over 50 million Americans. This condition can lead to social isolation, lower quality of life, and higher rates of dementia and depression.
Hearing loss can occur due to age related degeneration, genetic factors, trauma, chemotherapy induced, ototoxic medications and Viral or bacterial infections. The incidences of hearing loss are likely to rise further owing to increased exposure to hazardous noise levels and a growing geriatric population. Lifetime healthcare costs of untreated profound hearing loss are estimated to cost more than $1 million per person in the U.S alone.
A report by Zion Market Research projects a CAGR of 5.45% for the Global Hearing Aid market and estimates that it will be worth over USD 9.17 Billion by 2024.
A staggering 28.8 million U.S. adults could benefit from using hearing aids, according to data available at NIDCD. As of December 2012, roughly 58,000 devices have been implanted in adults and 38,000 in children in the U.S. However hearing aids pose many challenges and offer ineffective relief. New research focused on Gene therapy is offering hope to patients suffering from this disability leading to development of novel solutions to overcome the limitation posed by conventional hearing loss solutions.
The company manufactures OTIPRIO, a ciprofloxacin otic suspension 6% that acts as a fluoroquinolone antibacterial for treatment of bilateral otitis media and acute otitis externa with effusion for pediatric patients over 6 months of age, undergoing tympanostomy tube placement. It is a first-in-class single dose ciprofloxacin otic suspension that encompasses the company’s proprietary thermo sensitive liquid-to-gel technology that changes from liquid to gel once inside the middle ear.
It has an extensive product line targeted at OTIC disorders including Otitis Media, Acute Otitis Externa, Ménière’s disease, Tinnitus, CIHL and sensorineural hearing loss. Its patented Otonomy technology offers the ease of single administration, minimal peripheral exposure and overcomes patient compliance issues.
It is developing three programs that target different pathologies, first of which is Synopathy repair in case of speech-in-noise hearing loss (OTO-413), which is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF) that helps in neuron growth and synase repair. The Company has initiated a Phase 1/2 trial, which is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty.
The second candidate is an otoprotectant that can prevent cisplatin-induced hearing loss (CIHL) caused due to ototoxicity by exposure to platinum-based chemotherapeutic agents and aminoglycosides. The third candidate is OTO-6XX that aims to regenerate hair cells and treat hearing loss.
In addition the company’s pipeline consists of OTIDIVEX (dexamethasone) for the treatment of Ménière’s disease, currently undergoing the OTIVIDEX™ Phase 3 trial, the results of which are expected in the first half of 2020. OTO-313 (gacyclidine) for the treatment of Tinnitus currently being evaluated in a Phase 1/2 trial in tinnitus patients and expected to post results in H1,2020, OTO-413 (BDNF) for hidden hearing loss. Furthermore the Company is also developing OTO-510 (otoprotectant) for prevention of CIHL and OTO-6XX for severe hearing loss.
The company has entered into a co-promotion agreement with Mission Pharmacal Company for promoting OTIPRIO (ciprofloxacin otic suspension) for acute otitis externa (AOE) in the U.S; in consideration of an annual co-promotion fee and reimbursement of a part of product support expenses, and retain a share of gross profits from the sale of OTIPRIO to Mission’s accounts.
- The Company is expecting data from multiple clinical trials in 2020, chief among which is the readout from its Otividex follow-up phase 3 trials for the treatment of Ménière’s disease, which currently does not have an FDA –approved treatment. In addition it also expects to announce the results from its Phase 1/2 clinical trial of OTO-313, indicated for the treatment of patients with tinnitus. Positive results will help expedite the commercialization of its clinical candidates and generation of newer revenue streams.
- In September 2017, the Company faced a setback after its Phase III clinical trial AVERTS-1 for testing the efficacy of Otividex in patients with Meniere’s disease, failed to meet its primary and secondary endpoints. The Company however bounced back with the help of positive results from AVERTS-2 that demonstrated the benefits of Otividex in patients with Meniere’s disease.
- Based on previous results, the clinical trials are likely to succeed. The success of the trials will propel the Company’s growth and set pace for a bright future, however the Company will benefit from having a diverse pipeline in case of any further setbacks.
- As per its Second Quarter financial results, the Company reported cash and cash equivalents and short-term investments amounting to $78.5 million as of June 30, 2019, which are sufficient to fund its three ongoing clinical trials OTIVIDEX Phase 3 trial, OTO-313, Phase 1/2 trial, and OTO-413 Phase 1 / 2 trial as well as run its operations until 2021.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any position within the next 72 hours.
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