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Despite political pressure, Sound Pharmaceuticals CEO Jonathan Kil supports CDMO WuXi AppTec, as the BIOSECURE Act gets closer to becoming a reality. Image: Shutterstock/ WinWin artlab. Sound Pharmaceuticals wishes to maintain its relationship with 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. See Also: FDA approves updated mRNA vaccines for Covid-19 Codiak BioSciences gets grant for extracellular vesicles for disease treatment and prevention 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.

SEATTLE & INNSBRUCK, Austria--(BUSINESS WIRE)-- Sound Pharmaceuticals (SPI) is pleased to announce that it has received FDA notification that its Investigational New Drug Application (IND) may proceed involving SPI-1005 treatment and cochlear implantation (CI). The goal of this Phase 2 SPI-1005 (ebselen) trial is to reduce the loss of residual hearing during and after CI. Ebselen is a novel anti-inflammatory compound that mimics and induces the activity of Glutathione Peroxidase, an enzyme that is critical to hearing and balance. Ebselen has shown safety and efficacy in three different forms of acquired sensorineural hearing loss in adult patients, including loud sound exposure or acute noise induced hearing loss, Meniere’s disease, and antibiotic or aminoglycoside induced ototoxicity. The Phase 2 trial will enroll 40 adults who are CI candidates and scheduled to receive a cochlear implant. Eligible candidates will have residual low frequency hearing that is moderate to severely impaired and at risk of being lost after CI. The eligible participants will be randomized to receive 6 months of oral drug (SPI-1005 or placebo) treatment starting two days prior to CI and followed for an additional 6 months post-treatment to determine if SPI-1005 can prevent and/or treat the loss of residual hearing when compared to placebo. This marks the 6th IND involving SPI-1005, which has been tested in 13 studies enrolling over 850 participants to date. SPI-1005 is currently being tested in a pivotal Phase 3 trial involving active Meniere’s disease, where hearing loss, tinnitus, vertigo, and dizziness are common, and has received Fast Track designation by the FDA. SPI is collaborating with MED-EL, a leading medical device company that has pioneered the field of cochlear implantation over the last 40 years, especially in the area of hearing preservation. SPI and MED-EL entered into an exclusive worldwide collaborative agreement involving the use of SPI-1005 with cochlear implants. MED-EL has provided upfront, R&D, and equity support over the last 2 years. Currently, there are no FDA approved therapies for the treatment of sensorineural hearing loss, tinnitus, vertigo, or dizziness, and SPI-1005 is the only investigational new drug candidate in active Phase 3 trials for these indications or endpoints. The trials can be viewed online at , or by visiting . About Sound Pharmaceuticals (SPI) SPI is the leading biotechnology company focused on developing the first drug treatment for hearing loss and tinnitus. Sensorineural hearing loss, tinnitus, vertigo, and dizziness affect more than 50 million Americans and represent the largest neurologic disabilities throughout the industrialized world. SPI is a private company headquartered in Seattle WA and is led by co-founder and CEO Jonathan Kil, MD. Dr. Kil has led the R&D at SPI since inception and has been the Principal Investigator on multiple grants from the DoD, NIH, and the Cystic Fibrosis Foundation. About MED-EL MED-EL Medical Electronics, a leader in implantable hearing solutions, is driven by a mission to overcome hearing loss as a barrier to communication and quality of life. The Austrian-based, privately owned business was co-founded by industry pioneers Ingeborg and Erwin Hochmair, whose ground-breaking research led to the development of the world’s first micro-electronic multi-channel cochlear implant (CI), which was successfully implanted in 1977 and was the basis for what is known as the modern CI today. This laid the foundation for the successful growth of the company in 1990, when they hired their first employees. To date, MED-EL has more than 2,700 employees from around 80 nations and 30 locations worldwide. The company offers the widest range of implantable and non-implantable solutions to treat all types of hearing loss, enabling people in 136 countries enjoy the gift of hearing with the help of a MED-EL device. MED-EL’s hearing solutions include cochlear and middle ear implant systems, a combined electric acoustic stimulation hearing implant system, auditory brainstem implants as well as surgical and non-surgical bone conduction devices.

SEATTLE, May 3, 2023 /PRNewswire/ -- Sound Pharmaceuticals is pleased to announce that it has completed enrollment in its first Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory, for the treatment of Meniere's Disease (STOPMD-3). SPI-1005 is given orally and is the only drug demonstrated to improve both hearing loss and tinnitus in Meniere's Disease (MD) patients following 3 to 4 weeks of treatment in two prior randomized double-blind placebo-controlled trials (RCT) involving over 165 patients. The STOPMD-3 RCT screened over 250 patients for eligibility at 12 sites including some of the leading academic centers in the United States. Demand for the STOPMD-3 trial was higher than anticipated and enrollment completed six months ahead of schedule with over 220 eligible patients randomized to either SPI-1005 treatment (400 mg twice daily for 28 days) or matching placebo treatment in 9 months. Currently, SPI-1005 is the only investigational new drug being tested in an active Phase 2 or 3 RCT aimed at improving hearing loss, tinnitus, and/or dizziness. "It's both encouraging and humbling to see the demand for this third SPI-1005 study involving Meniere's disease patients" said Jonathan Kil, MD, Co-Founder and CEO. While STOPMD-3 is no longer recruiting new patients, it will continue to follow randomized patients for 3 months, after which, subjects may be invited to participate in an open-label extension (OLE) safety study of SPI-1005 treatment for up to 12 months. During the OLE, both auditory and vestibular function will be reassessed every 3 months. To date, no FDA-approved therapies exist for the treatment of sensorineural hearing loss, tinnitus, vertigo, or dizziness, which together comprise definite and probable MD. STOPMD-3 is led by Dr. Paul Lambert, Distinguished Professor and Former Chairman in the Dept. of Otolaryngology-HNS at MUSC in Charleston, SC, and past President of the American Neurotologic Society. Dr. Lambert, Dr. Shaun Nguyen, and their colleagues from MUSC also led the successful Phase 2b RCT involving SPI-1005 and MD patients. About Meniere's Disease (MD) MD is diagnosed by brief periods of episodic vertigo or dizziness, fluctuating low frequency hearing loss, and intermittent or constant tinnitus, and is thought to be due to a swelling of the inner ear. Patients are typically diagnosed between 40-65 years of age, and the auditory symptoms of hearing loss and tinnitus often involve only one ear. Some patients experience aural fullness or pressure that can also contribute to dizziness. As patients age, the hearing loss and tinnitus become worse resulting in severe to profound hearing loss or intractable tinnitus. For the definitive diagnosis of MD, the American Academy of Otolaryngology-Head & Neck Surgery guidance requires audiometric documentation of ≥30 dB of low frequency hearing loss in at least one ear using PTA. Loss of speech discrimination, especially in noisy environments or when tinnitus is present, is common in MD and other forms of sensorineural hearing loss. MD is currently managed with low salt diets, thiazide diuretics, and oral or locally injected steroids. Unfortunately, this standard of care has not been proven to be effective and is not FDA-approved for the treatment of definite or probable MD. About SPI-1005 SPI-1005 is an investigational new drug that contains ebselen, a new chemical entity. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase (GPx) activity, and is effective in reducing neuroinflammation across the central and peripheral nervous system. GPx activity is critical to several cell types and tissues in the inner ear, retina, prefrontal cortex of brain, lung, and kidney, and is often reduced during exposures to environmental insults or aging. Loss of GPx activity has been shown to result in sensorineural hearing loss in multiple animal models. SPI-1005 is being developed for several neurotologic indications including noise-induced hearing loss and two types of ototoxicity (hearing loss, tinnitus, dizziness, or vertigo) caused by aminoglycoside antibiotics (such as tobramycin or amikacin) or platinum-based chemotherapy (such as cisplatin or carboplatin). To date, no significant drug-drug interactions have been observed across multiple study populations including bipolar mania and treatment resistant depression. About Sound Pharmaceuticals A privately held biotechnology company is testing SPI-1005 under four other active Investigational New Drug Applications involving several neurotologic indications including aminoglycoside-induced ototoxicity co-funded by the CF Foundation and COVID-19 inpatients co-funded by the NIH. The leadership team consists of Jonathan Kil, MD, Co-Founder and CEO, Jacqueline Nguyen, MBA, VP Clinical Operations, John Sullivan, MBA, CFO, and G. Michael Wall, PhD, VP Pharmaceutical Development. Details of the SPI-1005 clinical trials can be viewed online at or by visiting . SOURCE Sound Pharmaceuticals