- The ResonateTM program provides access to a potential genetic diagnosis by offering genetic testing at no cost to eligible individuals, their insurance, or their healthcare providers
- A genetic diagnosis may help individuals and their healthcare providers better understand an individual’s condition and foster connections within the deaf and hard of hearing community
- In the future, as novel genetic medicines for disabling hearing loss enter clinical trials, a genetic diagnosis could also help individuals with auditory neuropathy and their healthcare providers determine their potential eligibility
[January 11, 2021] Akouos, Inc. (“Akouos”) (NASDAQ: AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, and Blueprint Genetics, a Quest Diagnostics company, today announced the Resonate program. The program offers genetic testing to eligible individuals with auditory neuropathy at no cost to participants, their insurance, or their healthcare providers.
Every year, thousands of children are born with disabling hearing loss and the majority of cases of congenital hearing loss are due to an underlying genetic cause. However, few individuals receive a genetic diagnosis and a key barrier is the availability and accessibility of genetic testing. The Resonate program seeks to overcome the barriers to genetic testing for individuals with auditory neuropathy, empower them to make informed choices, and provide potentially valuable insight to inform medical management.
“Akouos is committed to deepening the community’s understanding of the genetic forms of auditory neuropathy, a type of sensorineural hearing loss. Today, there are no pharmacologic therapies approved for the treatment of hearing loss. The development of new therapeutic options for underserved patient populations has become increasingly reliant on identification of the underlying genetic cause of a genetic disease, disorder, or condition,” said Manny Simons, Ph.D., founder, president, and CEO of Akouos. “We hope the Resonate program, along with our efforts to better understand the genetic causes and natural history of multiple forms of sensorineural hearing loss, will enable the research and development of novel genetic medicines for individuals with disabling hearing loss.”
“There are many different genetic changes that cause hearing loss. These changes can be complex and difficult for routine genetic testing to detect. Understanding the genetic cause of hearing loss requires a high-quality genetic testing strategy that includes the mitochondrial genome, difficult-to-sequence genes, and deep intronic variants in addition to copy number variants in order to increase the diagnostic potential for the program participant. We are excited to work with Akouos to offer our comprehensive genetic testing approach to individuals with auditory neuropathy,” says Tero-Pekka Alastalo, M.D., Ph.D., executive medical director of Blueprint Genetics.
The Resonate program is available in the United States and plans to expand to additional geographic regions throughout 2021. To be eligible for the program, individuals can be any age, and must have a current or prior clinical diagnosis of auditory neuropathy, or a medical history consistent with auditory neuropathy. Auditory neuropathy is a hearing disorder in which the inner ear successfully detects sound, but has a problem with sending sound from the ear to the brain. In many cases, genetic mutations cause auditory neuropathy. The Resonate program provides access to the Blueprint Genetics Comprehensive Hearing Loss and Deafness Panel that includes more than 230 genes associated with genetic forms of hearing loss. To help understand their results, participants in the United States also have access to genetic counseling provided by the program at no cost to participants, their insurance, or their healthcare providers.
Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy. www.akouos.com
About Blueprint Genetics
Blueprint Genetics, a Quest Diagnostics company, is a leading specialty genetics and bioinformatics company focused on providing genetic testing for inherited diseases. The company is based in Helsinki and Seattle, with a customer base spanning over 70 countries. www.blueprintgenetics.com
Cautionary Note Regarding Akouos Forward-Looking Statements
Statements in this press release about Akouos’s future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expectations for the Resonate program and the roll-out of the Resonate program. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Akouos’s plans to develop and, if approved, subsequently commercialize Akouos’s product candidates; the timing of and Akouos’s ability to submit applications for, and obtain and maintain regulatory approvals for, Akouos’s product candidates; Akouos’s expectations regarding Akouos’s regulatory strategy; Akouos’s expectations regarding Akouos’s ability to fund Akouos’s operating expenses and capital expenditure requirements with Akouos’s cash, cash equivalents and marketable securities; the potential advantages of Akouos’s product candidates; the rate and degree of market acceptance and clinical utility of Akouos’s product candidates; Akouos’s estimates regarding the potential addressable patient population for Akouos’s product candidates; Akouos’s commercialization, marketing and manufacturing capabilities and strategy; Akouos’s expectations regarding Akouos’s ability to obtain and maintain intellectual property protection for Akouos’s product candidates; Akouos’s intellectual property position; Akouos’s ability to identify additional products, product candidates, or technologies with significant commercial potential that are consistent with Akouos’s commercial objectives; the impact of government laws and regulations; Akouos’s competitive position and expectations regarding developments and projections relating to Akouos’s competitors and any competing therapies that are or become available; developments and expectations regarding developments and projections relating to Akouos’s competitors and Akouos’s industry; the impact of the COVID-19 pandemic on Akouos’s business, results of operations, and financial condition; Akouos’s ability to maintain and establish collaborations or obtain additional funding; and other factors discussed in the “Risk Factors” included in Akouos’s Quarterly Report on Form 10-Q for the three months ended September 30, 2020 filed with the Securities and Exchange Commission, and in other filings that Akouos makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Akouos expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Katie Engleman, 1AB
Courtney Turiano, Stern Investor Relations
Tero-Pekka Alastalo, executive medical director
Saara Salonoja, communication specialist