According to the National Institute on Deafness and other Communication Disorders, part of the National Institutes of Health, about two or three of every 1,000 children born in the US are born with hearing loss in one or both ears. Still, there is no Food and Drug Administration-approved drug to prevent or treat hearing loss, but one company hopes to change that.
Boston-based Akouos said Tuesday that it had raised $50 million in a Series A financing round to fund development of its adeno-associated viral vector (AAV)-based gene therapies for sensorineural hearing loss. New Enterprise Associates and 5AM Ventures, the company’s seed round investors, led the round, while fellow seed investor Partners Innovation Fund participated, along with new investors Sofinnova Ventures, RA Capital Management and Novartis Venture Fund.
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The funding will allow the company to bring its programs into clinical trials and accelerate development of multiple pipeline programs related to sensorineural hearing loss. Founder and CEO Manny Simons said in a phone interview that the company expects to start clinical trials in the next two to three years and to have initial regulatory interactions with the FDA starting next year.
“Overall, the hearing loss space, we think, is one of the largest unmet medical needs,” Simons said. Currently, he noted, the standard of care for sensorineural hearing loss is cochlear implants for those patients who are candidates. Sensorineural hearing loss – resulting from dysfunction or damage to sensory cells or nerve fibers in the inner ear – is found in most cases of newborn deafness and affects nearly a quarter of all adults older than 65, according to the company.
Still, research into potential drug-based solutions is a growing topic of interest. In a paper published in March, researchers at St. Jude’s Children’s Research Hospital in Memphis, Tennessee, found that inhibiting the kinase CDK2 protected mice and rats from noise- or drug-induced hearing loss, suggesting that it can prevent the death of inner ear cells. Also in March, Fennec Pharmaceuticals received FDA Breakthrough Therapy Designation for the drug Pedmark, for treating preventing hearing loss among children receiving the chemotherapy drug cisplatin for a type of pediatric liver cancer.
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