Sound Pharmaceuticals wishes to maintain its relationship with the WuXi AppTec for manufacturing its lead Meniere’s disease drug SPI-1005, amidst increasing scrutiny on Chinese companies in the US, says CEO Jonathan Kil.

In an exclusive interview with Pharmaceutical Technology Kil stated the company is “actively supporting WuXi”. The Biden administration set its sights on several Chinese firms with the introduction of the BIOSECURE Act, including WuXi AppTec. The BIOSECURE Act will withhold federal funding and contracts to companies should the biotech equipment or services used be sourced from ‘companies of concern’. These include several Chinese firms including WuXi. Under the Act, existing corporate ties will be permitted until 2032.

According to Reuters, information stating the company transferred US intellectual property to Beijing without consent was shared with US senators driving this bill.

Last month, Sound Pharmaceuticals completed a Phase III trial for its drug SPI-1005. Interim results from the study are expected this quarter. The STOPMD-3 trial (NCT04677972) investigated the effects of oral SPI-1005 in 201 Meniere’s disease patients to restore sensory neural hearing loss. Kil told Pharmaceutical Technology that results are expected to be published later this year, and the company is planning follow-up meetings with the FDA to review the data.

SPI-1005, which has a US Food and Drug Administration (FDA) fast track designation, is a formulation of ebselen, a compound that mimics glutathione peroxidase to reduce inflammation and protect auditory hair cells in the cochlea.

Sound Pharmaceuticals and WuXi AppTec have been partners for 18 years, during which WuXi has become the company’s leading supplier of manufacturing and development services. American corporate ties like this supply as much as 65% of WuXi revenue as of 2023, according to the Wall Street Journal.

WuXi AppTec’s market cap is currently HK$122.1bn (US$15.7bn). The company earned ¥7.98bn (US$1.12bn) in revenues in Q1 2024 according to WuXi financial reports.

Kil remains clear that Sound will seek a continued relationship with WuXi. “Some of us are working behind the scenes to make sure that WuXi gets treated fairly – we’re hoping that cooler heads prevail.” At the same time, the company is planning for any potential disruption to its manufacturing activities due to the BIOSECURE Act, said Kil.

Kil claims SPI-1005 has huge commercial potential in a space without any approved treatments. Around 38 million adults in the US experience hearing loss according to the National Council on Aging, of which approximately 90% of cases are thought to be sensorineural hearing loss, as per Healthline. According to the Cleveland Clinic, Tinnitus is believed to affect around 30-50 million people in the US.

https://www.pharmaceutical-technology.com/news/sound-pharmaceuticals-plans-to-stick-with-wuxi-amids-biosecure-act-rumblings/?cf-view