Audion Therapeutics BV

Audion Therapeutics BV is a clinical-stage biopharmaceutical company based in Amsterdam, The Netherlands, dedicated to the development of pharmacological therapies for hearing loss. Its core focus is acquired sensorineural hearing loss (SNHL), the most prevalent form of hearing loss, which arises from aging, noise exposure and other environmental factors and affects hundreds of millions of people worldwide. The company positions itself against a treatment landscape in which the only options are hearing aids and cochlear implants — prostheses that do not address the underlying physiological cause of the impairment and that perform poorly when hair cells have been lost or in noisy environments. Audion's scientific approach centers on the gamma secretase protein complex. The company is pioneering the use of a short-term treatment with a small-molecule gamma secretase inhibitor, which it believes has the potential to restore hearing, including in longer-established hearing loss. Its lead product candidate, AUD1001 (also known as LY3056480), is a gamma secretase inhibitor. The program is based on scientific discoveries from the Edge laboratory at Massachusetts Eye and Ear Infirmary (MEEI). Audion's intellectual property and know-how, including technologies and small molecules, were discovered and developed in collaboration with MEEI and Eli Lilly and are licensed by Audion. Audion has completed early clinical studies with its lead candidate in patients with sensorineural hearing loss. A phase I/IIa clinical study was conducted across three sites in Europe; according to the company, AUD1001 was shown to be safe and tolerable, and significant signs of efficacy were observed on a variety of hearing tests in multiple patients. The company describes its lead program as aimed at regenerating cells and neuronal connections lost in patients with acquired SNHL. Audion operates as a private, venture-style biotech company. Its management team and founders, together with a board of directors, are listed on its website. The company has also participated in collaborative research efforts, including the REGAIN Consortium, which announced a publication in Nature Communications in March 2024. Audion's stated mission is to provide a pharmacological treatment that can potentially address the needs of a large number of people suffering from acquired sensorineural hearing loss, a condition for which no pharmaceutical products currently exist.

Audion Therapeutics BV is a clinical-stage biopharmaceutical company based in Amsterdam, The Netherlands. It was established to develop pharmacological therapies for hearing loss, with an initial scientific foundation in discoveries from the Edge laboratory at Massachusetts Eye and Ear Infirmary (MEEI). The company's intellectual property and know-how, including technologies and small molecules, were discovered and developed in collaboration with MEEI and Eli Lilly and are licensed by Audion. Audion's lead program targets acquired sensorineural hearing loss (SNHL), the most prevalent form of hearing loss, which results from aging, noise exposure and other environmental factors. The company's approach focuses on the gamma secretase protein complex; a short-term treatment with a small-molecule gamma secretase inhibitor is intended to restore hearing, including in longer-established hearing loss. The lead product candidate is AUD1001 (LY3056480), a gamma secretase inhibitor. Audion has completed early clinical studies with AUD1001 in patients with sensorineural hearing loss. The company recently concluded a phase I/IIa clinical study across three sites in Europe. According to Audion, AUD1001 was shown to be safe and tolerable, and significant signs of efficacy on a variety of hearing tests were observed in multiple patients. The company describes its lead program as aimed at regenerating cells and neuronal connections that are lost in patients with acquired SNHL. In March 2024, Audion Therapeutics and the REGAIN Consortium announced a publication in Nature Communications. The company continues to develop its hearing-loss pipeline and is listed on Wikidata as a company in Amsterdam, The Netherlands.

• Audion Therapeutics and the REGAIN Consortium announce publication in Nature Communications.

• Audion concludes a phase I/IIa clinical study of AUD1001 across three sites in Europe, reporting safety, tolerability and signs of efficacy.

Clinical-stage biopharmaceutical company pioneering pharmacological restoration of hearing via gamma secretase inhibition, targeting the unmet need in acquired sensorineural hearing loss where only hearing aids and cochlear implants are currently available.

• AUD1001 (LY3056480)

  Small-molecule gamma secretase inhibitor; lead product candidate for acquired sensorineural hearing loss. Evaluated in a phase I/IIa study across three European sites.

1. 1Home - Audion Therapeuticsaudiontherapeutics.com
2. 2About Audion - Audion Therapeuticsaudiontherapeutics.com
3. 3Hearing Loss - Audion Therapeuticsaudiontherapeutics.com
4. 4Audion Therapeutics BV (Netherlands) - Wikidatawikidata.org