Spiral Therapeutics Completes $8.25M Financing and Initiates Phase 2 Trial in Ménière's Disease

SOUTH SAN FRANCISCO, Calif., Jan. 9, 2023 /PRNewswire/ -- Spiral Therapeutics, Inc. ("Spiral"), a clinical-stage company focused on delivering therapies for inner ear disorders, today announced that the Company recently completed an $8.25M financing, with new proceeds that will fund the continuing development of its lead candidate, SPT-2101, for the treatment of inner ear inflammation. Existing investors Savoir Capital and Catalio Capital Management participated in this financing and were joined by Humboldt Fund and other family office investors.

SPT-2101 is a sustained-release steroid formulation designed for precise inner ear administration using Spiral's novel delivery procedure. Spiral recently completed enrollment of an open label pilot clinical study of SPT-2101 in 10 patients with Ménière's disease. Data from this study confirmed the favorable safety profile of SPT-2101, as well as marked improvements from baseline in the frequency and severity of patient-reported vertigo episodes at 3 months and in other key efficacy outcome measures. Further, pharmacokinetic data provided confirmation of the durability of Spiral's drug delivery platform.

A randomized, placebo-controlled Phase 2 clinical trial was initiated this month and will further investigate the safety and efficacy of SPT-2101 given as a single administration. Up to 30 subjects with unilateral Meniere's disease will be enrolled across four clinical centers in Australia.

Ménière's disease is a chronic condition characterized by acute vertigo attacks, tinnitus, fluctuating hearing loss and a feeling of aural fullness. Of these symptoms, the vertigo attacks are typically most troubling for patients since they disrupt daily activities and are difficult to anticipate and manage. According to the National Institute of Deafness and Other Communication Disorders, there are more than 600,000 patients diagnosed with Ménière's disease in the United States. There is no known cure for Ménière's disease and there are currently no FDA-approved drug treatments available.

"Ménière's disease is a debilitating inner ear disorder usually diagnosed in patients between 40 to 60 years of age but can occur at any age. Patients suffer with hearing and balance symptoms that often continue throughout their lifetime" said Dr. Jafri Kuthubutheen, Clinical Associate Professor in the Division of Surgery, Medical School at the University of Western Australia, and Principal Investigator in SPT-2101's Phase 2 trial. "The safety profile and clinical data from the initial SPT-2101 trial shows great promise for the unmet needs of people suffering from Ménière's disease."

"Hearing loss and balance disorders are among the largest unmet needs in medicine. 430 million worldwide suffer from disabling hearing loss, while there are no FDA-approved drug treatments available," said Dr. Charles Limb, Professor and Chief of Otology and Neurotology at UCSF, and Chief Medical Officer of Spiral Therapeutics. "Enabled by the superior precision and durability of our novel drug delivery platform, we are focused on bringing solutions to these patients, starting with SPT-2101."

"I am grateful to our investors for their support of Spiral over the years," said Hugo Peris, Founder and Chief Executive Officer of Spiral Therapeutics. "With their support, the guidance of our experienced board, and the hard work of our team, we have the opportunity to grow Spiral into the global pioneer in the effective treatment of inner ear disease."

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 sustained-release steroid formulation for the treatment of inner ear inflammation. For more information, visit: www.spiraltx.com.

For Spiral:
Hugo Peris, CEO ([email protected])
(650) 453-0893

SOURCE Spiral Therapeutics, Inc.