This project will develop the first regimen meeting WHO criteria for a pan-TB indication, ie, not requiring knowledge of RIF susceptibility. The regimen will test sutezolid at 2 dose levels, with the approved anti-TB drugs bedaquiline and pretomanid, in a phase 2c trial. It will also test whether the addition of N-acetylcysteine (NAC), a re-purposed host-directed WHO essential medicine, can protect the lung and liver against oxidative damage, preserve lung function, and accelerate the eradication of MTB infection by replenishing glutathione (GSH).

开始日期2023-07-28

申办/合作机构

The Aurum Institute

[+7]

NCT03959566

/ Completed临床2期IIT

A Phase IIB, Open-Label, Randomized Controlled Dose Ranging Multi-Center Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Exposure-Response Relationship of Different Doses of Sutezolid in Combination With Bedaquiline, Delamanid and Moxifloxacin in Adult Subjects With Newly Diagnosed, Uncomplicated, Smear-Positive, Drug-sensitive Pulmonary Tuberculosis

This study is an open-label, randomized, controlled, multi-center Phase IIB dose-finding trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response-relationship of different doses of sutezolid (STZ) in combination with bedaquiline, delamanid and moxifloxacin in adults with newly diagnosed, uncomplicated, smear positive and drug sensitive pulmonary tuberculosis. Participants will be randomized to one of five arms containing bedaquiline, delamanid and moxifloxacin with different doses of STZ (0mg, 600mg once daily (OD), 1200mg OD, 600 mg twice daily (BD), 800 mg BD). Study treatment duration will be three months, followed by a follow-up period of 2 weeks.
The primary objective is to identify the optimal dose of sutezolid to be used in subsequent studies that provides the best efficacy at acceptable safety of the drug by describing the safety, tolerability and exposure toxicity relationship of sutezolid (and its main metabolite) given over three months, in combination with standard-dose bedaquiline, delamanid and moxifloxacin, compared to standard-dose bedaquiline, delamanid and moxifloxacin alone.

开始日期2021-05-06

申办/合作机构

Ludwig-Maximilians-Universität München

[+4]

NCT01785186

/ Completed临床2期IIT

A Multiple Arm, Multiple Stage, Phase 2, OL, Randomized, Controlled Trial to Evaluate 4 Treatment Regimens of SQ109, Increased Doses of Rifampicin, and Moxifloxacin in Adults With Newly Diagnosed, Smear-positive Pulmonary Tuberculosis

This study is a multiple-arm, multiple-stage (MAMS), phase 2, open label, randomized, controlled clinical trial that will compare the efficacy and safety of four experimental four drug regimens with a standard control regimen in patients with smear positive, pulmonary tuberculosis (TB). Patients will be randomly allocated to the control or one of the four experimental regimens in the ratio 2:1:1:1:1. Experimental regimens will be given for 12 weeks. Thereafter, participants in the experimental arms will receive continuation phase treatment for 14 weeks containing standard-dose rifampicin and isoniazid. All participants will receive 25 mg of vitamin B6 (pyridoxine) with every dose of INH to prevent INH-related neuropathy. Interim analyses will be conducted during the trial for efficacy, with the aim of identifying experimental arms that perform below a pre-specified efficacy threshold; these arms will then be stopped from further recruitment.
Following the first scheduled interim analysis on March 3rd, the Trial Steering Committee (TSC) followed a recommendation of the independent data monitoring committee (IDMC) and has stopped the enrolment into two of the arms in the MAMS-TB trial: HRZQ and HR20ZQ, based on these arms not meeting the pre-specified gain in efficacy over control. Importantly, there was no safety concern that prompted stopping recruitment to these arms. They recommended that recruitment to arm 2 (HRZQ) and 3 (HR20ZQ) be terminated as there was insufficient evidence that these regimens could shorten treatment. Importantly, there was no evidence that either arm was inferior to standard treatment (the control arm) with regards to efficacy. There was, however, sufficient evidence that the other intervention arms HR35ZE and HR20ZM could shorten treatment to continue enrolling patients.

开始日期2013-04-01

申办/合作机构

Ludwig-Maximilians-Universität München

[+4]

100 项与 Sequella, Inc. 相关的临床结果

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0 项与 Sequella, Inc. 相关的专利（医药）

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项与 Sequella, Inc. 相关的文献（医药）

2025-06-13·ACS Infectious Diseases

Broad-Spectrum Activity and Mechanisms of Action of SQ109 on a Variety of Fungi

Article

作者: Calderin, Jorge D. ; Wiederhold, Nathan P. ; Ostrosky-Zeichner, Luis ; Patterson, Hoja ; Kordalewska, Milena ; Fratti, Rutilio ; Zhou, Ruijie ; Garcia-Rubio, Rocio ; Perlin, David S. ; Zhang, Chi ; Shor, Erika ; Oldfield, Eric ; Nacy, Carol ; Malwal, Satish R. ; Pandey, Akanksha M.

We investigated the activity of the tuberculosis drug SQ109 against 16 fungal pathogens: Candida albicans, C. auris, C. glabrata, C. guilliermondi, C. kefyr, C. krusei, C. lusitaniae, C. parapsilosis, C. tropicalis, Cryptococcus neoformans, Rhizopus spp., Mucor spp., Fusarium spp., Coccidioides spp., Histoplasma capsulatum and Aspergillus fumigatus. MIC values varied widely (125 ng/mL to >64 μg/mL) but in many cases we found promising (MIC ∼ 4 μg/mL) activity as well as MFC/MIC ratios of ∼ 2. SQ109 metabolites were inactive. The activity of 12 analogs of SQ109 against Saccharomyces cerevisiae correlated with protonophore uncoupling activity, suggesting mitochondrial targeting, consistent with the observation that growth inhibition was rescued by agents which inhibit ROS species accumulation. SQ109 disrupted H⁺/Ca²⁺ homeostasis in S. cerevisiae vacuoles, and there was synergy (FICI ∼ 0.26) with pitavastatin, indicating involvement of isoprenoid biosynthesis pathway inhibition. SQ109 is, therefore, a potential antifungal agent with multitarget activity.

2021-08-17·Antimicrobial agents and chemotherapy2区 · 医学

Pharmacokinetics and Target Attainment of SQ109 in Plasma and Human-Like Tuberculosis Lesions in Rabbits

2区 · 医学

Article

作者: Gengenbacher, Martin ; Wijnant, Gert-Jan ; Kaya, Firat ; Egbelowo, Oluwaseun ; Dartois, Véronique ; Zimmerman, Matthew D. ; Denti, Paolo ; Carter, Claire L. ; Gausi, Kamunkhwala ; Aldridge, Bree B. ; Degefu, Yonatan ; Wang, Han ; Sarathy, Jansy P. ; Van, Nhi ; Nacy, Carol

Drug-resistant tuberculosis (TB) accounts for over 20% of all fatalities due to drug-resistant pathogens. With recently approved drugs and a promising drug candidate pipeline, the challenge faced by clinical developers is prioritization of drug combinations with the best potential to improve cure rates and shorten treatment duration.

2018-06-01·The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease4区 · 医学

MPT64 patch test for the diagnosis of active pulmonary tuberculosis: a randomised controlled trial in Peru

4区 · 医学

Article

作者: Gilman, R. H. ; Moore, D. A. J. ; Pope, V. ; Hererra, J. Coronel ; Lopez Romero, S. ; Vargas-Prada, S. ; Yafac, J. ; Sacksteder, K. A. ; Sanchez Rios, E.

SETTING:

There remains a lack of effective and inexpensive diagnostic tools for active tuberculosis (TB) disease. Testing immune responses to proteins secreted by Mycobacterium tuberculosis, such as MPT64, may be a diagnostic option.

OBJECTIVE:

To evaluate the sensitivity and specificity of a patch test using MPT64 for the diagnosis of active TB disease.

DESIGN:

This randomised, double-blind, placebo-controlled, prospective study in Lima, Peru, involved 55 healthy controls and 457 symptomatic individuals referred for routine TB testing by the National TB Control Programme. All subjects underwent a comprehensive diagnostic workup, and received an active patch on one arm and a placebo patch on the opposite arm, which were read after 4 days.

RESULTS:

Eighty-one (18%) of the symptomatic participants were classified as having definite TB, while an additional 98 (21%) had probable TB. The patch tests performed the same in both groups, with a sensitivity of 27% and specificity of 74%. The area under the receiver operating characteristic curve was 0.495 (95%CI 0.425-0.565).

CONCLUSIONS:

Contrary to existing literature, the MPT64 patch was not sensitive and specific to detect active TB. Given the potential of the test, understanding possible differences in the protein source or underlying genetic factors should be explored further.

项与 Sequella, Inc. 相关的新闻（医药）

2008-10-29

·BioSpace

Sequella, Inc. Presents Data on Synergy Between Investigational New TB Drugs SQ109 and TMC207

Study results to be presented at 2008 ICAAC/IDSA Joint Meeting ROCKVILLE, Md., Oct. 28 /PRNewswire/ -- Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing products to treat infectious diseases of epidemic potential, announces the successful demonstration of synergistic activities and improvement of minimal inhibitory concentration (MIC) resulting from in vitro combination studies of Sequella lead TB drug candidate, SQ109, and Tibotec's lead TB drug candidate, TMC207. Both drug candidates are currently undergoing human clinical studies. Results from these studies were presented on October 28th at the Interscience Conference on Anti-Microbial Agents and Chemotherapeutics (ICAAC) and Infectious Disease Society of America (IDSA) joint meeting in Washington, DC. The collaboration between Sequella and Tibotec was designed to investigate in vitro interactions of SQ109 for synergistic, additive, or antagonistic activity in the presence of TMC207, using a number of clinical and laboratory strains of both drug sensitive and drug resistant M. tuberculosis (MTB). In vitro interactions investigated included synergy studies, rate of killing, post antibiotic effect and intracellular activity against MTB in macrophages. There were no antagonistic activities observed in any combination studies. SQ109 and TMC207 in combination were either synergistic or additive with the various MTB strains and showed increased rate of killing, enhanced post antibiotic effect and intracellular killing activity. Results showed that the SQ109 and TMC207 drug combination was extraordinary potent, with greater than 90% kill of MTB as early as 1 day after drug combination exposure. Dr. Carol Nacy, CEO of Sequella said, "We are very pleased to be collaborating with Tibotec, a world renowned product development organization, and we look forward to our continuing partnership to examine these important drug synergies in animal models of TB." The next step of the collaboration will be to complete a series of in vivo studies in animal models of TB, currently underway. About SQ109 The company's lead drug candidate, SQ109, completing Phase I clinical trials, is a new diamine antibiotic that could replace one or more of the current first-line anti-tuberculosis drugs to simplify or shorten therapy. SQ109 was granted U.S. FDA Fast Track and FDA/EMEA Orphan Drug Designation in 2007. About Sequella Sequella is a clinical stage biopharmaceutical company focused on commercializing improved treatments for infectious diseases of epidemic potential. The company leverages its global influence, R&D platforms and infectious disease expertise to proactively address emerging health threats. Through focused execution, clear commercialization pathways, and strategic partnerships, Sequella intends to commercialize a broad product portfolio designed to treat global health threats with significant market opportunity. Forward-Looking Statement This press release contains forward-looking statements that are subject to risks and uncertainties, and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Sequella disclaims any intent or obligation to update forward-looking statements, except as required by law. CONTACT: Alicia Moran, +1-410-991-7027, for Sequella, Inc. Web site:

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药物(靶点)	适应症	全球最高研发状态

SQ-641 ( Phospho-N-acetylmuramoyl pentapeptide transferase )	克罗恩病更多	临床前
SQ-922 ( Phospho-N-acetylmuramoyl pentapeptide transferase )	肺结核更多	临床前
SQ-109 ( MmpL3 )	肺结核更多	无进展
Sutezolid ( 50S subunit )	肺结核更多	无进展
Tuberculosis Peptide Vaccine (EpiVax/Sequella/Valneva)	结核更多	无进展