Spiral Therapeutics, Inc.

[31-October-2023] Partnership with VeDA enhances Spiral's commitment to patient outreach and education, while gaining invaluable insights from the VeDA Patient Registry SAN FRANCISCO, Oct. 31, 2023 /PRNewswire/ -- Spiral Therapeutics Inc ("Spiral"), a clinical-stage pharmaceutical company leading the way in therapies for inner ear disorders, today announced a strategic partnership with the Vestibular Disorders Association (VeDA). This alliance aims to improve the lives of patients suffering from balance disorders like Meniere's Disease through targeted outreach, collaborative patient education programs, and data-driven research. "Joining forces with VeDA is a significant milestone for Spiral, as it aligns with our commitment to address the unmet medical needs in the field of inner ear disorders," said Hugo Peris, CEO of Spiral Therapeutics. "We're honored to support VeDA's mission and excited about the opportunity to significantly improve patient lives." "VeDA is honored to partner with Spiral in our mutual effort to support Meniere's patients on their journey back to balance," said Cynthia Ryan, Executive Director of VeDA. "We're excited about the potential their new treatment offers to improve the lives of people struggling with vertigo, hearing loss, and tinnitus." This collaboration grants Spiral access to VeDA's Patient Registry on Meniere's patients, enriching its ongoing research efforts. Additionally, VeDA will facilitate targeted outreach to Meniere's clinicians and patients in the United States and Australia. Both organizations will also collaborate on educational programs to further patient understanding of treatment nuances such as the placebo effect. Ongoing Clinical Progress Spiral continues to advance its inner ear programs, including its lead candidate SPT-2101 for Meniere's Disease. The data from SPT-2101's open label trial in Australia continues to support the safety and superior efficacy of Spiral's proprietary drug delivery platform. Encouraged by these milestones, Spiral plans to submit an Investigational New Drug (IND) application for SPT-2101 in the United States in 2024. 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 long-acting steroid formulation for the treatment of inner ear inflammation. For more information, visit: About the Vestibular Disorders Association (VeDA) The Vestibular Disorders Association is a global organization committed to providing support, education, and advocacy to vestibular patients and the healthcare professionals who treat them. For more information, visit: For VeDA: Cynthia Ryan, Executive Director (367768@email4pr.com) (503) 294-9085

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss. San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone. In December, Otonomy announced it’s letting all of its employees go after the board approved a dissolution plan, capping a fruitless search for strategic alternatives . But as part of the liquidation process, it explored selling the assets still in its pipeline — with proceeds from any sales to be distributed back to shareholders. Spiral said it “plans to leverage valuable data and insights gained from Otonomy’s 15 years of experience in the field of inner ear disorders” and accelerate its own lead drug’s path to late-stage clinical trials. While founder and CEO Hugo Peris suggested the Otonomy assets will be integrated into Spiral’s pipeline, he did not specify whether Spiral will further develop those programs. Endpoints News has reached out for comment. The company raised $8.25 million earlier this year to fund its work on therapies for inner ear disorders. Like OTO-104, Spiral’s top program, SPT-2101, is a sustained-release steroid formulation, except it utilizes a different drug delivery platform to reach the inner ear. And as with OTO-104, Spiral is testing SPT-2101 in Ménière’s disease, a condition characterized by sudden “attacks” on the inner ear, such as vertigo and tinnitus, sometimes resulting in hearing loss. OTO-104 flunked several mid- and late-stage trials despite revisions to the clinical trial protocol and statistical analysis. One of the first things it did with the data acquired from Otonomy, Spiral added, was to compare the clinical data to what it’s seeing with SPT-2101 in the same patient population. The conclusion? Its drug is statistically superior to both OTO-104 and placebo in terms of helping patients get away from definitive vertigo days at three months. For an undisclosed sum, Spiral also bought 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 that had succeeded OTO-104 as the lead drug but also disappointed in Phase II. Notably, the biotech did not acquire OTO-825, a preclinical gene therapy for congenital hearing loss previously spotlighted by Otonomy execs.

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: