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Akouos Raises $50 Million Series A for Gene Therapies for Hearing Loss

Led by seed investors 5AM Ventures and New Enterprise Associates (NEA).

According to the National Institute on Deafness and Other Communication Disorders, about 2 to 3 out of every 1,000 children in the US are born with a detectable level of hearing loss in one or both ears. About 15% of adults report some trouble hearing, and the severity of hearing loss is highly correlated with age. Nearly 25% of people aged 65 to 74, and 50% percent of those who are at least 75 years old have disabling hearing loss. The World Health Organization says that 466 million people worldwide have disabling hearing loss—34 million of whom are children—and that this number is expected to increase to over 900 million by 2050.

Hearing loss is broadly categorized as either sensorineural (problems with the sensory cells or nerve fibers of the inner ear), conductive (problems in the ear canal, ear drum, or middle ear and its small bones) or mixed. Sensorineural hearing loss is found in most cases of newborn deafness and affects nearly a quarter of all adults over the age of 65, according to the Hearing Loss Association of America, making it the most common form of hearing loss and one of the most common of all sensory disorders. Hearing aids don’t help with this type of hearing loss.

Boston-based Akouos—the name presumably is derived from the Greek “?????” meaning “I hear”—is developing adeno-associated viral vector (AAV)-based gene therapies to restore and preserve hearing, with an initial focus on monogenic (single gene mutation) forms of sensorineural hearing loss. The company announced today that it has raised $50 million in a Series A financing co-led by seed investors 5AM Ventures and New Enterprise Associates (NEA). Partners Innovation Fund, another seed investor, and new investors Sofinnova Ventures, RA Capital Management and Novartis Venture Fund also participated. According to the company’s Form D filing with the SEC, the Series A is being done in two equal tranches. “The first tranche equal to approximately 50% of the total offering amount [of $50.1 million] was sold on July 17, 2018. The remaining tranche will be sold upon the occurrence of certain events.”

Akouos founder and CEO Manny Simons, PhD (Source: Harvard Business School).

Akouos also announced the appointment of Michael McKenna, MD, a scientific co-founder of the company, as Chief Medical Officer and Jennifer Wellman as SVP, Regulatory. Dr. McKenna is a renowned neurotologist and pioneer of translational inner ear drug delivery approaches. He holds the Joseph B. Nadol, Jr. Chair and is the most recent director of the Division of Otology and Neurotology at Massachusetts Eye and Ear, and has been professor of otolaryngology at Harvard Medical School since 2006. Ms. Wellman is a veteran in AAV gene therapy development, with broad translational experience across multiple therapeutic areas over the past two decades. She was a co-founder of Spark Therapeutics ONCE, where she led regulatory strategy for Luxturna, the first in vivo gene therapy approved in the US. Akouos also added two independent board directors: Arthur Tzianabos, PhD, president and CEO of Homology Medicines FIXX and Chris Smith, former CEO of Cochlear Ltd.

Hearing loss is one of the greatest challenges in medicine today, and with no FDA-approved therapies available, an area of severe unmet need. Akouos has a unique opportunity to bring forward the world’s first precision medicines for individuals with genetically-driven forms of hearing loss. The expansion of our team and investor base, in addition to our founding partnerships with Massachusetts Eye and Ear and Lonza, puts us in a strong position to advance the clinical studies that will convert the promise of our approach into meaningful therapies.

– Manny Simons, PhD, founder and CEO, Akouos.

Akouos is leading the investigation of innovative therapies for a range of monogenic and acquired hearing disorders There are more than 150 forms of genetically-defined forms of hearing loss, and additional implicated genes continue to be identified. Furthermore, the role of genetics in more complex forms of acquired hearing loss is becoming clearer with an increase in genome sequencing worldwide.

– Michael McKenna, MD, Chief Medical Officer, Akouos.

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