Spiral Therapeutics Acquires Otonomy Assets to Boost Inner Ear Disorders Pipeline and Appoints Industry Leaders to Board

• Spiral Therapeutics acquires assets from Otonomy, including data, patent rights, and inventory related to OTO-104, OTO-510, and OTO-413
• Clinical data analysis suggests Spiral's lead candidate, SPT-2101, may offer improved treatment outcomes for Meniere's disease compared to OTO-104 and placebo
• Spiral appoints biotech industry veterans Anthony Adamis, M.D. and Frédéric Guerard, Pharm.D. to its Board of Directors

SAN FRANCISCO, March 29, 2023 /PRNewswire/ -- Spiral Therapeutics, Inc. ("Spiral"), a clinical-stage company focused on delivering therapies for inner ear disorders, announced today the completion of its acquisition of selected assets from Otonomy, Inc. ("Otonomy"), following the stockholder approval of Otonomy's dissolution. The transaction includes preclinical and clinical data related to OTO-104 (OTIVIDEX), a sustained-exposure formulation of dexamethasone; patent rights, data and know-how related to OTO-510, an otoprotectant; and preclinical and clinical data and inventory related to OTO-413, a sustained-exposure formulation of Brain-Derived Neurotrophic Factor (BNDF).

Spiral plans to leverage the valuable data and insights gained from Otonomy's 15 years of experience in the field of inner ear disorders to drive further innovation around its novel drug delivery platform and to accelerate SPT-2101's path to late-stage clinical trials.

Spiral's lead candidate, SPT-2101 is a proprietary sustained-release steroid formulation designed for precise inner ear administration using Spiral's novel drug delivery platform. The ongoing Phase 2 extension trial in Ménière's disease aims to further investigate the effect size of SPT-2101 given as a single administration. Up to 30 subjects with unilateral Ménière's disease are being enrolled across four clinical centers in Australia.

Spiral conducted a comprehensive evaluation of the OTO-104 data from clinical trials in Ménière's disease, comparing it with the available clinical data on SPT-2101 in the same patient population. The analysis showed that SPT-2101 is statistically superior to OTO-104 and placebo in the percentage of patients experiencing full resolution of definitive vertigo days (DVDs) at three months. The earlier effectiveness of SPT-2101 drives superiority across every time point, and other endpoints are also favorable to SPT-2101.

Spiral also announced the appointment of biotech industry veterans Anthony (Tony) Adamis, M.D. and Frédéric (Fred) Guerard, Pharm.D., to its Board of Directors, effective immediately.

Dr. Adamis, who co-founded EyeBio in 2021 and Eyetech in 2002, previously served as senior vice president of Product Development and Development Innovation at Genentech, a member of The Roche Group. Over the course of his career, he has led development programs in multiple therapeutic areas and has overseen 25 U.S. Food and Drug Administration (FDA) approvals.

Fred Guerard served as CEO of Graybug Vision and led the planning and successful execution of the company's IPO in September 2020. Prior to Graybug, Mr. Guerard spent twenty years of his career at Novartis and Alcon, where he led the Worldwide ophthalmology and otology franchises.

"We are excited to integrate Otonomy's assets into our pipeline to further strengthen our position as a leading company focused on inner ear disorders," said Hugo Peris, Founder and Chief Executive Officer of Spiral Therapeutics. "The comparison between SPT-2101 and OTO-104 data reinforces our confidence in the potential of our lead candidate and the effectiveness of our novel drug delivery platform."

"We are thrilled to welcome Tony and Fred, two exceptional leaders in ophthalmology and medicine, to the Spiral Therapeutics team," said Eugene de Juan, MD, Executive Chairman of Spiral Therapeutics. "Their profound strategic and transformational start-up experience, including Tony's track record of driving key innovations in medicine and Fred's profound understanding of ophthalmology and otology, make them invaluable assets to our mission. We are confident that they will help guide Spiral's ultimate goal of addressing the critical unmet need of hearing loss."

About Spiral Therapeutics
Spiral Therapeutics is a clinical-stage company focused on delivering therapies for inner ear disorders. Spiral's novel drug delivery platform allows for minimally invasive, precise and durable exposure of drugs to the cochlea. Spiral is advancing a therapeutic pipeline with focus on hearing loss and balance disorders. Spiral's lead program, SPT-2101, is a proprietary sustained-release steroid formulation for the treatment of inner ear inflammation. For more information, visit: www.spiraltx.com

Media Contact
Hugo Peris, Spiral CEO
[email protected] 
(650) 453-0893

SOURCE Spiral Therapeutics, Inc.