The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005?
The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.
Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.
The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.

Start Date01 Jul 2024

Sponsor / Collaborator

Sound Pharmaceuticals, Inc.

[+1]

KCT0008687 / RecruitingNot ApplicableIIT

A prospective observational study on the effectiveness of ANI and SPI as a measure of pain in patients undergoing cystoscopic procedure under remifentanil infusion

Start Date18 Apr 2023

Sponsor / Collaborator

Inje University Sanggye Paik Hospital

NCT04677972 / CompletedPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005

The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment.

Start Date02 Aug 2022

Sponsor / Collaborator

Sound Pharmaceuticals, Inc.

100 Clinical Results associated with Ebselen

100 Translational Medicine associated with Ebselen

100 Patents (Medical) associated with Ebselen

1,221

Literatures (Medical) associated with Ebselen

01 Dec 2024·Biomaterials

Ultrasound-triggered functional hydrogel promotes multistage bone regeneration

Article

Author: You, Yuanyuan ; Luo, Xueshi ; Liu, Hongmei ; Xu, Renhao ; Cao, Zhiying ; Zheng, Wenyi ; He, Yanni ; Chen, Tianfeng ; Chang, Yanzhou ; Ma, Li

The dysfunction of bone mesenchymal stem cells (BMSCs), caused by the physical and chemical properties of the inflammatory and repair phases of bone regeneration, contributes to the failure of bone regeneration. To meet the spatiotemporal needs of BMSCs in different phases, designing biocompatible materials that respond to external stimuli, improve migration in the inflammatory phase, reduce apoptosis in the proliferative phase, and clear the hurdle in the differentiation phase of BMSCs is an effective strategy for multistage repair of bone defects. In this study, we designed a cascade-response functional composite hydrogel (Gel@Eb/HA) to regulate BMSCs dysfunction in vitro and in vivo. Gel@Eb/HA improved the migration of BMSCs by upregulating the expression of chemokine (C-C motif) ligand 5 (CCL5) during the inflammatory phase. Ultrasound (US) triggered the rapid release of Ebselen (Eb), eliminating the accumulation of reactive oxygen species (ROS) in BMSCs, and reversing apoptosis under oxidative stress. Continued US treatment accelerated the degradation of the materials, thereby providing Ca²⁺ for the osteogenic differentiation of BMSCs. Altogether, our study highlights the prospects of US-controlled intelligent system, that provides a novel strategy for addressing the complexities of multistage bone repair.

29 Oct 2024·Proceedings of the National Academy of Sciences

QSOX1 facilitates dormant esophageal cancer stem cells to evade immune elimination via PD-L1 upregulation and CD8 T cell exclusion

Article

Author: Li, Yan ; Zhang, Xiao-Ping ; Zhu, Ying-Hui ; Chen, Wo-Ming ; Zhang, Yu ; Wei, Jia-Ru ; Guan, Xin-Yuan ; Zeng, Ting-Ting ; Li, Lei ; Zhang, Baifeng

Dormant cancer stem cells (DCSCs) exhibit characteristics of chemotherapy resistance and immune escape, and they are a crucial source of tumor recurrence and metastasis. However, the underlying mechanisms remain unrevealed. We demonstrate that enriched Gzmk + CD8 + T cells within the niche of esophageal DCSCs restrict the outgrowth of tumor mass. Nonetheless, DCSCs can escape immune elimination by enhancing PD-L1 signaling, thereby maintaining immune equilibrium. Quiescent fibroblast-derived quiescin sulfhydryl oxidase 1 (QSOX1) promotes the expression of PD-L1 and its own expression in DCSCs by elevating the level of reactive oxygen species. Additionally, high QSOX1 in the dormant tumor niche contributes to the exclusion of CD8 + T cells. Conversely, blocking QSOX1 with Ebselen in combination with anti-PD-1 and chemotherapy can effectively eradicate residual DCSCs by reducing PD-L1 expression and promoting CD8 + T cell infiltration. Clinically, high expression of QSOX1 predicts a poor response to anti-PD-1 treatment in patients with esophageal cancer. Thus, our findings reveal a mechanism whereby QSOX1 promotes PD-L1 upregulation and T cell exclusion, facilitating the immune escape of DCSCs, and QSOX1 inhibition, combined with immunotherapy and chemotherapy, represents a promising therapeutic approach for eliminating DCSCs and preventing recurrence.

28 Oct 2024·Chemistry – A European Journal

Double Chalcogen Bonding Recognition Arrays in Solution

Article

Author: Sosso, Gabriele C. ; Romito, Deborah ; Kählig, Hanspeter ; Bonifazi, Davide ; Tecilla, Paolo

AbstractN‐substituted pyridino‐based congeners of Ebselen, named here as Pyrselen, incorporating proximal Se and N atoms, undergo dimerization in solution and the solid state through a dual donor‐acceptor arrangement of chalcogen bonding sites. Dimerization constants were measured within the 5–50 M−1 range. Computational studies on the dimers depict a notable charge‐transfer contribution to the association, validating Pyrselen as an effective scaffold for designing chalcogen‐bonding‐based recognition motifs.

News (Medical) associated with Ebselen

30 Oct 2024

·www.prnewswire.com

TXN Systems Raises SEK 25 Million Series A to Advance First-in-Class Antibiotic

EbsArgent targets urinary tract infections, with early indications of efficacy against many species of multidrug-resistant bacteria STOCKHOLM, Oct. 30, 2024 /PRNewswire/ -- Thioredoxin Systems AB (TXN Systems), a pharmaceutical company developing a first-in-class antibiotic for multidrug-resistant urinary tract infections, today announced the close of an approximate SEK 25 million (USD 2.4M) Series A financing round to support the development of EbsArgent™, the company's first-in-class bactericidal antibiotic for urinary tract infections (UTIs) caused by antibiotic-resistant bacteria. The round includes substantial investments from prominent life sciences entrepreneurs and investors Mikael Lönn, MD and Jens Mogensen, alongside GU Ventures, Vasa Angels, and the state-owned venture capital firm Annexstruktur - as well as from Gobia Enterprises, a family-owned investment firm focusing on life sciences. "There hasn't been a new class of antibiotics developed since 1987, and I'm incredibly excited about the potential of EbsArgent. With its novel mechanism of action on a new target, and extensive testing that has demonstrated its effectiveness against a wide range of drug-resistant pathogens, EbsArgent could give us a valuable new weapon in the fight against antibiotic resistance," Lönn said. "TXN Systems' world-class science is backed by a proven strong team, and we look forward to supporting the company as it advances EbsArgent into the clinic." A study published in the journal The Lancet in September 2024 estimates the world could see more than 39 million deaths directly caused by antimicrobial resistance (AMR) from 2025 to 2050. More than 2.8 million bacterial infections occur in the U.S. each year, and 35,000 people die because of them, according to the U.S. Centers for Disease Control and Prevention (CDC), the country's public health agency. Europe sees similar numbers, with about 35,000 AMR-related deaths occurring annually, according to the European Commission. AMR happens when pathogens evade the medicines intended to kill them. TXN Systems will use proceeds from the Series A to complete preclinical studies of its patented EbsArgent and initiate Phase I clinical trials of the therapeutic in UTIs. Multidrug-resistant UTIs have become a pressing problem for the medical community, and managing urological procedures in hospitals is emerging as a growing challenge due to antibiotic resistance. Almost a quarter of all infections are UTIs, and studies have shown that approximately 9 percent of all urological inpatients develop complicated UTIs during their hospital stay. "Urinary tract infections, once easily cured, are becoming more and more resistant to multiple antibiotics and some standard treatments no longer work," said TXN Systems CEO Elias Arnér, MD, PhD. "However, the burden of antimicrobial resistance across healthcare will be of unprecedented levels, in all geographic regions. We have evaluated EbsArgent against a wide range of clinically derived bacterial strains of many different species, each with pronounced resistance against most, or all, of the currently available antibiotics. EbsArgent shows strong efficacy against all of them. We're extremely pleased to attract such high-caliber investors, and grateful for the confidence they have in our novel technology. We look forward to working with them to advance EbsArgent." EbsArgent is a combination drug containing silver ions and the compound ebselen to achieve a novel mechanism of action. By utilizing ebselen to disable the essential bacterial thioredoxin enzyme system and leveraging silver ions to synergistically enhance ebselen uptake, EbsArgent achieves a high level of bactericidal activity. Several studies have validated the bacterial thioredoxin reductase enzyme as a novel target for antimicrobial therapeutic development. No occurrence of cross-resistance with other antibiotics has been observed, likely because the thioredoxin system is not targeted by commercially available antibiotics and ebselen is a novel type of molecule compared to other antibiotics. In mouse models, EbsArgent has demonstrated safety, low toxicity, and good efficacy in multidrug-resistant gram-negative infections and multidrug-resistant urinary tract infections specifically. It also shows promising activity against the formation of biofilms with many bacterial strains, including E. coli, which is preferable because bacteria grown as biofilm make complicated UTIs more difficult to treat. About Thioredoxin Systems AB Thioredoxin Systems AB (TXN Systems) is a private pharmaceutical company developing a first-in-class antibiotic to treat multidrug-resistant urinary tract infections. The company's patented EbsArgent™, a combination drug containing silver ions and the compound ebselen, has a novel mechanism of action that uses ebselen to disable the essential bacterial thioredoxin enzyme system and silver ions to synergistically enhance ebselen uptake, to fight bacterial infections in new ways and without triggering resistance. TXN Systems aims to combat the growing global health threat of antimicrobial resistance that world health authorities predict could directly cause about 35 million deaths worldwide by 2050. The company was founded by the late Professor Arne Holmgren, a leading expert in redox biology, whose groundbreaking work led to the discovery and development of EbsArgent. TXN Systems is based in Solna, Sweden and funded by leading venture capitalists and private life sciences investors. For more information please visit . CONTACTS For Thioredoxin Systems AB Elias Arnér [email protected] For Media Susan Thomas Endpoint Communications +1-619-540-9195 [email protected] This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

19 Aug 2024

·www.pharmaceutical-technology.com

Sound Pharmaceuticals plans to stick with WuXi amid BIOSECURE Act rumblings

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.

VaccineFinancial StatementPhase 3Fast TrackClinical Result

20 May 2024

·www.biospace.com

Sound Pharmaceuticals’ IND Involving Cochlear Implantation Allowed by the FDA

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.

Phase 2Phase 3Fast Track

100 Deals associated with Ebselen

External Link

KEGG	Wiki	ATC	Drug Bank
-	Ebselen	-	DB12610

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meniere Disease	Phase 3	US	Sound Pharmaceuticals, Inc.	02 Aug 2022
Cystic Fibrosis	Phase 2	US	Sound Pharmaceuticals, Inc.	21 Jul 2017
Disease Progression	Phase 2	US	Sound Pharmaceuticals, Inc.	21 Jul 2017
Ototoxicity	Phase 2	US	Sound Pharmaceuticals, Inc.	21 Jul 2017
Bipolar Disorder	Phase 2	-	Daiichi Sankyo Co., Ltd.	-
Hearing Loss	Phase 2	-	Daiichi Sankyo Co., Ltd.	-
Tinnitus	Phase 2	-	Daiichi Sankyo Co., Ltd.	-
Chemotherapy-induced damage	Discovery	US	Sound Pharmaceuticals, Inc.	15 Jan 2018
Lung Cancer	Discovery	US	Sound Pharmaceuticals, Inc.	15 Jan 2018
Mania	Discovery	GB	Sound Pharmaceuticals, Inc.	01 Oct 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02819856 (NEWS) Manual	Phase 2	Ototoxicity	60	SPI-1005	(bnfotxeahf) = Interim analysis of the Phase 2b results shows a dose proportional decrease in the ototoxicity rate (from placebo, 200, 400, to 600 mg ebselen), with the 400 and 600 mg dose having ototoxicity rates of 44% and 43% at 4-weeks (400 mg, p-value <0.05). jpxnoxdlop (qtefiksmbx )	Positive	30 Jan 2024
				Placebo
NCT03325790 (CTgov)	Phase 2	Meniere Disease	149	Placebo (Placebo)	wawyefugvu(kxjhswckyn) = ffuwbxktkr wqtqjmctsl (ecxauauqlk, bqreoujqdk - nqszeufugb) View more	-	14 Aug 2023
				200mg SPI-1005 BID (200mg SPI-1005 Twice Daily (BID))	wawyefugvu(kxjhswckyn) = vufdlcohcp wqtqjmctsl (ecxauauqlk, iosqflyuzr - hlcilozvye) View more
NCT03013400 (Pubmed) Manual	Phase 2	Mania	68	SPI-1005	(vqmdnowjbm): difference = -1.36 (95% CI, -3.75 to 1.17), P-Value = 0.29 View more	Positive	01 Dec 2020
				Placebo
NCT01444846 (Pubmed \| Lancet) Manual	Phase 2	Hearing Loss, Noise-Induced	81	ebselen	-	Positive	02 Sep 2017
				Placebo	(lbldsxajrt) = vqvnhrjyri mghbapnqzt (chsohsihel )

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