Sound Pharma's SPI-1005 Completes Crucial Phase 3 Trials, Offering New Hope For Meniere’s Disease Patients

Sound Pharmaceuticals is excited to announce the completion of the Phase 3 clinical trial for SPI-1005, a groundbreaking anti-inflammatory treatment for Meniere’s Disease (STOPMD-3). SPI-1005, an oral capsule taken twice daily, stands out as the only potential therapy that has shown significant improvement in hearing loss and tinnitus for Meniere’s Disease patients, as documented in previous Phase 1b and 2b studies involving over 165 patients.

The STOPMD-3 trial enrolled eligible participants into a randomized controlled trial (RCT) for three months, followed by an open-label extension (OLE) of SPI-1005 for six months, with an optional additional six months. This trial represents the longest treatment study involving an investigational drug for hearing loss or tinnitus ever completed. The unblinding of RCT data and presentation of interim topline results will take place this quarter.

Randomization for STOPMD-3 began on August 2, 2022, and the final patient visit for the 12-month open-label extension was completed on July 25, 2024. A total of 254 patients were screened for eligibility across 11 leading academic centers in the US. Of these, 221 eligible patients were randomized to receive either SPI-1005 (400 mg twice daily for 28 days) or a matching placebo and were followed for 84 days. Subsequently, 201 patients continued with SPI-1005 in the open-label extension for up to 12 months. Jonathan Kil, MD, Co-Founder & CEO stated, “We are grateful to all the patients that participated in this pivotal trial of SPI-1005.” SPI-1005 is the sole investigational new drug evaluated in a Phase 3 trial in the past three years with the objective of improving hearing loss, tinnitus, and/or dizziness.

STOPMD-3 was spearheaded by Dr. Paul Lambert, Distinguished University Professor and Chair Emeritus of the Department of Otolaryngology-HNS at the Medical University of South Carolina in Charleston, and former President of the American Neurotologic Society.“To our knowledge, this Phase 3 study is the longest continuous treatment trial to improve hearing loss/tinnitus in patients living with Meniere’s Disease,” commented Dr. Lambert. Moreover, Dr. Lambert, Dr. Shaun Nguyen, and their team at MUSC also headed the successful Phase 2b randomized controlled trial of SPI-1005 in patients with Meniere's Disease.