Spiral Therapeutics Welcomes New Investment, Cementing Its Leadership in Neurotology

• Investment led by Esperante Ventures and Ferring Ventures: Additional funding to support expanded SPT-2101 clinical trial.
• Progress with SPT-2101 for Meniere's Disease: Encouraging data from the Australian clinical trial validates Spiral's proprietary drug delivery platform, with plans to submit its US IND by late 2024.

SOUTH SAN FRANCISCO, Calif., Aug. 30, 2023 /PRNewswire/ -- Spiral Therapeutics, Inc. ("Spiral"), a clinical-stage company focused on delivering therapies for inner ear disorders, today announced a new round of financing led by Esperante Ventures and Ferring Ventures SA. This infusion of capital will propel the company's innovative approach to treating inner ear disorders, including the collection of additional clinical data for its lead program SPT-2101 for Meniere's Disease, and the continued development of its hearing loss pipeline. As part of this financing, Spiral welcomes the addition of Dean Slagel, Managing Director of Esperante Ventures, to its Board of Directors.

SPT-2101 is a sustained-release steroid formulation designed for minimally invasive, precise and durable administration to the inner ear using Spiral's novel drug delivery platform. Last year Spiral completed enrollment of an open label clinical study of SPT-2101 in patients with Meniere'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 superiority of Spiral's drug delivery platform.

A randomized, placebo-controlled clinical trial expansion was initiated earlier this year 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 are being enrolled across multiple sites in Australia.

Building upon the recently acquired data from Otonomy, Spiral expects to submit an Investigational New Drug (IND) application for SPT-2101 to initiate its pivotal trials in the US by late 2024.

Hugo Peris, CEO of Spiral Therapeutics, said, "This fresh round of investment reflects the confidence in our unique drug delivery approach and technology, and strengthens our resolve to innovate in the field of neurotology. With the recent acquisition of Otonomy assets and our growing therapeutic pipeline, we are positioning Spiral as a forerunner in the field."

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

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

SOURCE Spiral Therapeutics, Inc.