Sound's for hearing loss: Co's drug wins FDA breakthrough tag for Meniere’s disease

Here's a new ray of hope for new hope for patients suffering from Meniere’s disease (MD) and sensorineural hearing loss

Seattle based Sound Pharmaceuticals (SPI) has announced that the FDA has granted Breakthrough Therapy Designation (BTD) to its investigational drug SPI-1005 for treating hearing loss in patients with MD.

MD, a complex inner ear disorder, causes low-to-mid frequency hearing loss, tinnitus, vertigo, and dizziness, and currently has no FDA-approved drug treatments.

This marks the first BTD ever awarded for MD. SPI-1005, an oral anti-inflammatory, is also the first drug to receive BTD for the treatment of sensorineural hearing loss—the most common auditory disorder associated with aging and dysfunction of the peripheral and central nervous system. Hearing loss is assessed using pure-tone audiometry (PTA) and speech discrimination tests including the words-in-noise (WIN) test, considered gold standards in diagnosing auditory impairment.

“We look forward to working closely with the FDA to get SPI-1005 ready for a future NDA filing,” said Dr Jonathan Kil, Co-Founder and CEO of SPI.

SPI-1005 recently became the first drug to achieve co-primary endpoints in a pivotal Phase 3 trial (STOPMD-3), demonstrating clinically meaningful improvements in both PTA and WIN. A second open-label Phase 3 trial is currently enrolling to gather additional safety data for chronic dosing in patients with probable and definite MD.

The drug has also shown favorable safety and efficacy across five other clinical trials, including Phase 1b, 2b, and Phase 2 studies in acute noise-induced hearing loss and aminoglycoside-induced ototoxicity.

SPI-1005 had previously received Fast Track Designation following the completion of a Phase 2b trial.

According to the FDA, “A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.

"In contrast, a fast track designation is for a drug that treats a serious or life-threatening condition, and nonclinical or clinical data demonstrate the potential to address unmet medical needs for the serious condition.”