Spiral winds up for phase 2 sustained-release steroid trial with $8M financing

Spiral Therapeutics has landed investor support for its sustained-release steroid candidate, raising $8.25 million to fund phase 2 development of a treatment for a debilitating inner ear disorder. 

San Francisco-based Spiral has created a platform for delivering anti-inflammatory and neuroprotective drugs to the ear to treat balance disorders and hearing loss. The delivery platform is designed to enable continuous drug diffusion across the membrane and into the cochlea for one to three months to improve on the current methods of administering drugs to treat inner ear disorders.

Spiral is applying the technology to the treatment of Ménière's disease, a rare disorder of the inner ear that causes symptoms including vertigo, tinnitus and hearing loss. A steroid, dexamethasone, has shown promise in the indication and is given via injections into the ear. Using its delivery technology, Spiral wants to enable precise, sustained-release dosing of steroids to treat Ménière’s. 

Investors have signed up to bankroll the work. Existing investors Savoir Capital and Catalio Capital Management joined with Humboldt Fund and other family office investors to pump $8.25 million into the business.

Spiral will use the money to run a phase 2 clinical trial that got underway in Australia this month. The study will enroll up to 30 subjects with unilateral Meniere's across four clinical centers to investigate the effects of a single administration of the sustained-release steroid SPT-2101. 

Charles Limb, M.D., professor and chief of otology and neurotology at the University of California, San Francisco and chief medical officer at Spiral, outlined the opportunities open to the company in a statement to disclose the financing round. 

“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. 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,” Limb said.