SAN DIEGO, CALIFORNIA — Spiral Therapeutics, a clinical-stage company specializing in therapies for inner ear disorders, has successfully completed the acquisition of selected assets from Otonomy. This followed the stockholder approval of Otonomy’s dissolution.
The acquisition includes preclinical and clinical data related to OTO-104 (OTIVIDEX), 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 Therapeutics aims to leverage the data and insights gained from Otonomy’s 15 years of experience to drive further innovation around its novel drug delivery platform and to accelerate SPT-2101’s path to late-stage clinical trials.
SPT-2101, Spiral’s lead candidate, 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 is designed to investigate the effect size of SPT-2101 given as a single administration. The trial will enroll up to 30 subjects with unilateral Ménière’s disease 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 has 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 co-founded EyeBio in 2021 and Eyetech in 2002, and previously served as senior vice president of Product Development and Development Innovation at Genentech, a member of The Roche Group. 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. 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.”
–Hugo Peris, Founder and CEO of Spiral Therapeutics
“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.
Source: Spiral Therapeutics
