An Open-Label, Multiple-Ascending Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LSVT-1701 as an Add-on to Standard of Care Antibiotics for the Treatment of Complicated Methicillin-Sensitive and -Resistant Staphylococcus Aureus Bacteremia Including Left- and Right-sided Infective Endocarditis

This study evaluates safety and tolerability of endolysin-derived LSVT-1701 (tonabacase) as an add-on to standard of care (SOC) antibiotic therapy for the treatment of patients with complicated Staphylococcus aureus bacteremia (SAB), including left- and right-sided infective endocarditis (IE).

开始日期2022-05-01

申办/合作机构

Lysovant Sciences, Inc.

NCT03446053

/ Completed临床1期

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dosing, Dose-Escalating Phase 1b Study to Evaluate the Safety, PK, PD and Immunogenicity of N-Rephasin® SAL200 After Continuous IV Infusion in Healthy Volunteers

To evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of N-Rephasin® SAL200 following single and multiple ascending doses in healthy male volunteers after continuous intravenous infusion over 60 minutes.

开始日期2018-02-07

申办/合作机构

iNtRON Biotechnology, Inc.

NCT03089697

/ Terminated临床2期

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase IIa Clinical Study to Evaluate Safety and to Explore Efficacy of N-Rephasin® SAL200, in Patients With Persistent Staphylococcus Aureus Bacteremia

This study is performed to evaluate safety and to explore the efficacy of a single intravenous dose of N-Rephasin® SAL200 (3 mg/kg) in addition to the conventional standard treatment, for persistent Staphylococcus aureus bacteremia in patients, for more than 48 hours even after antibiotic treatment to which Staphylococcus aureus is susceptible.

开始日期2017-03-07

申办/合作机构

iNtRON Biotechnology, Inc.

100 项与 Tonabacase 相关的临床结果

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100 项与 Tonabacase 相关的转化医学

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100 项与 Tonabacase 相关的专利（医药）

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项与 Tonabacase 相关的文献（医药）

2022-03-15·Antimicrobial agents and chemotherapy2区 · 医学

A Phase 1 Study To Evaluate Safety and Pharmacokinetics following Administration of Single and Multiple Doses of the Antistaphylococcal Lysin LSVT-1701 in Healthy Adult Subjects

2区 · 医学

Article

作者: Wire, Mary Beth ; Hwang, Jun Gi ; Jun, Soo Youn ; Jang, In-Jin ; Huang, David B. ; Lee, Seung-Hwan

Thirty-two healthy male subjects (8 per cohort) were randomized 6:2 to active:placebo. LSVT-1701, an antistaphylococcal lysin, was administered intravenously as a 6-mg/kg single dose and as 1.5, 3, and 4.5 mg/kg twice daily for 4 days.

2021-11-01·Diagnostic microbiology and infectious disease4区 · 医学

Anti-staphylococcal lysin, LSVT-1701, activity: In vitro susceptibility of Staphylococcus aureus and coagulase-negative staphylococci (CoNS) clinical isolates from around the world collected from 2002 to 2019

4区 · 医学

Article

作者: Huang, David B ; Sader, Helio S ; Rhomberg, Paul R ; Borroto-Esoda, Katyna ; Gaukel, Eric

LSVT-1701 (previously known as SAL200), is a novel, recombinantly-produced, bacteriophage-encoded lysin that specifically targets staphylococci via cell wall enzymatic hydrolysis. In vitro activities of LSVT-1701 and comparators were tested against 415 Staphylococcus aureus and coagulase-negative staphylococci (CoNS) clinical isolates expressing various resistance phenotypes. The isolates were collected worldwide from 2002 to 2019 and tested for in vitro susceptibility using broth microdilution methodology performed according to the Clinical and Laboratory Standards Institute (CLSI) guidelines. Minimum inhibitory concentration (MIC) interpretations were based on CLSI and EUCAST criteria. MIC₉₀ for all S. aureus, methicillin-susceptible S. aureus, methicillin-resistant S. aureus, and CoNS, were 2, 2, 2 and 2 µg/ml, respectively. LSVT-1701's activity was not adversely affected by resistance to antimicrobial comparators against this worldwide collection of S. aureus and CoNS clinical isolates. The results of this study support further clinical development of LSVT-1701 to treat staphylococcal infections, including those caused by multidrug resistance isolates.

2019-04-01·Antimicrobial agents and chemotherapy

Efficacy of Intranasal Administration of the Recombinant Endolysin SAL200 in a Lethal Murine Staphylococcus aureus Pneumonia Model

Article

作者: Oh, Myoung-don ; Jun, Kang Il ; Choe, Pyoeng Gyun ; Park, Sang Won ; Kim, Hong Bin ; Park, Wan Beom ; Kim, Nam-Joong ; Song, Kyoung-Ho ; Bae, Ji Yun ; Kang, Chang Kyung ; Kim, Eu Suk ; Bang, Ji-Hwan

SAL200 is derived from a phage endolysin and is a novel candidate drug for the treatment of Staphylococcus aureus infection. We investigated the efficacy of the recombinant endolysin SAL200 in a lethal murine pneumonia model.

项与 Tonabacase 相关的新闻（医药）

2025-05-13

·PRNewswire

iNtRON Seeks a Strategic Partner to Explore the Promising Market for MRSA Decolonization

Aiming to Provide a Novel Solution Against Post-Operative MRSA Infections Demonstrated its Efficacy and Safety through previous Clinical Trials Company seeks global partners to co-develop toward Commercialization SEOUL, South Korea and BOSTON, May 13, 2025 /PRNewswire/ -- iNtRON Biotechnology, Inc., a biotechnology company focused on developing innovative endolysin-based new biological drug for superbugs and unmet medical needs, today announced the strategic initiative aimed at expanding the clinical applications of SAL200 and seeking a strategic partnership to target the prevention of surgical site infections (SSIs) by nasal MRSA decolonization. Methicillin-resistant Staphylococcus aureus (MRSA) remains one of the most dangerous superbugs worldwide, with rising infection rates in both hospital and community settings. Even in sterile operating environments, MRSA-related SSIs frequently originate from the patient's own nasal or skin, potentially leading to extended hospital stays, increased treatment costs, and in severe cases, serious systemic infections such as sepsis, osteomyelitis, or endocarditis. High-risk surgical patients including those undergoing implant or cardiac surgeries, or those with compromised immune systems face significantly elevated risks of MRSA infections. Although mupirocin-based nasal ointments have been used as a standard of care product for the prevention of SSI, resistance rates are continuously increasing, leaving clinicians with few effective solution. As an intravenous injection drug for infective endocarditis and bacteremia, SAL200 has already demonstrated a strong safety profile through Phase 1a/1b and Phase 2a clinical trials. Encouraged by recent feedback from key clinical experts, iNtRON is now pursuing an additional indication for SAL200 as a pre-operative MRSA nasal decolonization solution. According to recent industry reports, the global nasal decolonization market which is closely related to SSI prevention was valued at USD 1.6 billion in 2024 and is projected to grow at a CAGR of 7.5%, driven by heightened hospital infection control regulations and growing concern over antimicrobial resistance. With the strategic expansion of the clinical application of SAL200 for the promising market opportunity, iNtRON is seeking global partners to co-develop a new formulation, delivery route, and product type as a nasal or topical use, and to collaborate on preclinical and clinical studies aimed at commercialization. "As SAL200 has demonstrated its strong efficacy and safety as an I.V. injection formulation in the previous clinical studies, we believe it can be developed into a nasal or topical use formulation through a much simplified clinical trial process" said YOON Kyung Won, CEO. "We believe SAL200 can fill a critical gap in MRSA nasal decolonization, an area in urgent need of a new solution. We aim to begin clinical development for this new indication in 2025 and are confident that our novel solution will significantly advance efforts to prevent MRSA-related SSIs. We are open to all types of partnerships including co-development and licensing, and welcome discussion with those who share our vision." About iNtRON Biotechnology, Inc. iNtRON Biotechnology () is a clinical-stage biopharmaceutical company at the forefront of bacteriophage-derived technology and immune therapeutics. The company specializes in developing first-in-class and first-in-concept bio-drugs to combat infectious diseases and immune-related disorders. Since its foundation and subsequent IPO on KOSDAQ, iNtRON has focused on global R&BD collaborations and is committed to delivering innovative therapies that address urgent medical needs in infectious disease and immunotherapy. Contact Us YOON, Kyung Won (Kevin) / CEO, Vice President / [email protected] SHIN, Tae Kyu (TK) / BD Team Leader / [email protected] it is iNtRON. SOURCE iNtRON Biotechnology, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期

2025-02-18

·Endpoints

Septerna ends Phase 1 trial for hypoparathyroidism drug; Sanofi’s Merilog is approved

Plus, news about Basilea, TME Pharma and Perceive Biotherapeutics: Septerna stops work on Phase 1: The newly public biotech ended a healthy volunteer trial for SEP-786, its hypoparathyroidism candidate, after “unanticipated events of elevated unconjugated bilirubin levels.” The company had been targeting a readout in the middle of this year, CEO Jeffrey Finer told Endpoints News at last month’s JP Morgan Healthcare Conference. The biotech now expects to select a follow-up candidate “to accelerate toward the clinic later this year to quickly regain momentum with our PTH1R program,” Finer said Tuesday. Multiple drugmakers are doing work in the rare endocrine disorder field, and Ascendis’ hypoparathyroidism drug was recently approved. Septerna’s stock $SEPN was down about 63% on Tuesday morning. — Kyle LaHucik FDA approves Sanofi’s Merilog: It’s the first FDA-approved, fast-acting insulin biosimilar to Novo Nordisk’s NovoLog, and is now the third insulin biosimilar approved by the agency to treat diabetes. — Alexis Kramer Basilea abandons MRSA drug ahead of clinic entry: The Swiss biotech decided not to exercise its option for its endolysin candidate, dubbed tonabacase, because it didn’t meet “stringent risk-return criteria.” Basilea licensed the option for tonabacase from iNtRON Biotechnology back in 2023 and did a preclinical assessment of the candidate last year. — Ayisha Sharma German cancer biotech has new eye focus: TME Pharma is planning to establish a “new entity” focused on the “rapid advancement” of NOX-E36 for ophthalmic indications, with support from private investors. The company said it has enough supply of the drug for initial preclinical and clinical studies. TME is also looking for a strategic partner for its lead asset, dubbed NOX-A12, for glioblastoma. — Ayisha Sharma Ophthalmology biotech reveals $15M Series A: Johnson & Johnson’s corporate venture arm, Deerfield Management and other investors are backing Perceive Biotherapeutics. The small molecule startup, a spinout of Perceive Pharma, is working on “neuroprotective therapeutics” for glaucoma and other eye conditions. — Kyle LaHucik

上市批准临床1期

2025-02-18

·FierceBiotech

Basilea opts not to take MRSA antibiotic into clinic due to \'stringent risk-return criteria\'

“This decision demonstrates that we are focused on stringent risk-return criteria when making portfolio decisions,” Basilea Pharmaceutica said.\n Basilea Pharmaceutica has cited its “stringent risk-return criteria” as a reason for not taking up its option to bring a MRSA antibiotic into clinical development.Basilea secured the license option for the endolysin antibiotic, called tonabacase, from Korea’s iNtRON Biotechnology in 2023. Basilea had been conducting a preclinical evaluation of the asset throughout 2024 ahead of a decision on whether to secure the exclusive rights to take tonabacase into human trials.When it signed the agreement with iNtRON, Basilea pointed to preclinical evidence of tonabacase’s activity against methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA and MSSA) as well as coagulase-negative staphylococci.“There continues to be a high medical need for new treatment options for patients with persistent infections caused by Gram-positive bacteria and tonabacase is an exciting and innovative asset for us to evaluate over the coming months,” Basilea Chief Medical Officer Marc Engelhardt, M.D., said back in 2023. “If the outcome of our evaluation is positive and we enter into a full license agreement, we may be able to start directly a phase 2 clinical study in 2025.” That trial is now off the menu, as Basilea has completed its own preclinical profiling of the medicine and “taken the decision not to pursue further development,” the Swiss company said in its full-year earnings report.“This decision demonstrates that we are focused on stringent risk-return criteria when making portfolio decisions,” the company added.Basilea currently markets Cresemba for invasive fungal infections and Zevtera for bacterial infections. The low return on investment means many of the biggest biopharmas have given up working on new antifungals or antibiotics in recent years—although GSK in particular has continued to sign deals and post encouraging clinical results against infections like gonorrhea.Meanwhile, Basilea has swum against the tide, pivoting away from cancer toward anti-infectives last year. The company’s clinical pipeline is headed up by fosmanogepix, an antifungal licensed from Amplyx Pharmaceuticals that Basilea is planning to enter into its second phase 3 study against mold infections.Basilea’s work developing new antifungals received a significant boost last September from the U.S. Department of Health and Human Services, which signed off on up to $268 million of funding to the biopharma over more than a decade.

$Basilea opts not to take MRSA antibiotic into clinic due to \'stringent risk-return criteria\'$

引进/卖出临床3期

100 项与 Tonabacase 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
右侧感染性心内膜炎	临床2期	美国	Lysovant Sciences, Inc.	2022-05-01
金黄色葡萄球菌菌血症	临床2期	美国	Lysovant Sciences, Inc.	2022-05-01
耐甲氧西林金黄色葡萄球菌引起的菌血症	临床2期	韩国	iNtRON Biotechnology, Inc.	2017-03-07
耐甲氧西林金黄色葡萄球菌感染	临床1期	韩国	iNtRON Biotechnology, Inc.	2013-08-06

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03446053 (Pubmed) 人工标引	临床1期	-	32	LSVT-1701	選醖窪膚憲艱夢淵憲願(鑰襯選餘顧醖顧廠襯獵) = predominantly of mild intensity. The most common TEAEs were chills, pyrexia, headache, infusion site events, cough, rhinorrhea, and increases in C-reactive protein. 構醖廠壓製選齋網衊繭 (衊鏇糧鏇糧遞觸鬱衊積 )	积极	2022-03-15
NCT03089697 (CTgov)	临床2期	耐甲氧西林金黄色葡萄球菌引起的菌血症 \| 金黄色葡萄球菌菌血症	25	Placebo (Placebo)	壓願夢蓋鑰鏇簾艱構製 = 齋積遞願繭壓淵網網選窪網範蓋製簾顧齋夢選 (築餘淵窪繭壓製鏇鑰淵, 糧憲鏇製窪構範廠選積 ~ 窪膚築製餘選襯壓醖憲) 更多	-	2021-08-17
NCT03089697 (CTgov)	临床2期	耐甲氧西林金黄色葡萄球菌引起的菌血症 \| 金黄色葡萄球菌菌血症	25	N-Rephasin® SAL200 (N-Rephasin® SAL200)	壓願夢蓋鑰鏇簾艱構製 = 範夢遞鹹願衊網網艱憲窪網範蓋製簾顧齋夢選 (築餘淵窪繭壓製鏇鑰淵, 淵遞衊淵網鹽鑰鹽淵憲 ~ 網憲膚觸製鬱艱糧蓋築) 更多	-	2021-08-17