Multi-center, Randomized, Evaluator-blind, Active-controlled,Parallel-group Design to Determine Safety, Tolerability, and Efficacy of Multiple Daily Administration of LFF571 for 10 Days in Patients With Moderate Clostridium Difficile Infections

This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections.

Start Date01 Oct 2010

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with LFF-571

100 Translational Medicine associated with LFF-571

100 Patents (Medical) associated with LFF-571

Literatures (Medical) associated with LFF-571

01 Jul 2024·International Journal of Antimicrobial Agents

Fighting against Clostridioides difficile infection: Current medications

Review

Author: Quan, Min ; Lv, Xiaoju ; Zhang, Xiaoxia ; Wang, Xiaohui ; Fang, Qingqing ; Zong, Zhiyong

Clostridioides difficile (formerly Clostridium difficile) has been regarded as an 'urgent threat' and a significant global health problem, as life-threatening diarrhoea and refractory recurrence are common in patients with C. difficile infection (CDI). Unfortunately, the available anti-CDI drugs are limited. Recent guidelines recommend fidaxomicin and vancomycin as first-line drugs to treat CDI, bezlotoxumab to prevent recurrence, and faecal microbiota transplantation for rescue treatment. Currently, researchers are investigating therapeutic antibacterial drugs (e.g. teicoplanin, ridinilazole, ibezapolstat, surotomycin, cadazolid, and LFF571), preventive medications against recurrence (e.g. Rebyota, Vowst, VP20621, VE303, RBX7455, and MET-2), primary prevention strategies (e.g. vaccine, ribaxamase, and DAV132) and other anti-CDI medications in the preclinical stage (e.g. Raja 42, Myxopyronin B, and bacteriophage). This narrative review summarises current medications, including newly marketed drugs and products in development against CDI, to help clinicians treat CDI appropriately and to call for more research on innovation.

03 Apr 2019·Expert Opinion on Investigational DrugsQ2 · MEDICINE

Investigational drug therapies currently in early-stage clinical development for the treatment of clostridioides (clostridium) difficile infection

Q2 · MEDICINE

Review

Author: Tran, Mai-Chi N. ; Kullar, Ravina ; Goldstein, Ellie J. C.

INTRODUCTIONClostridioides (Clostridium) difficile Infection (CDI) is an urgent global threat causing ~500,000 infections annually in the United States of America (USA) and is associated with a 36% 30-day attributable mortality rate. Despite the availability of three therapeutic agents, CDI recurrence occurs in 20-40% of patients, with a 30-40% second recurrence rate in these patients. Consequently, there is a need for novel agents for treating CDI.AREAS COVEREDWe searched MEDLINE, PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov for agents in early stages of clinical development. These drugs include ACX-362E, DS-2969b, LFF 571, RBX2660, ribaxamase, ridinilazole that have advanced to at least phase 2 and several other drugs in phase 1 development.EXPERT OPINIONThe challenge for these new agents is three-fold: (1) to have a novel approach such as a different target/mechanism of action; (2) be 'significantly' better than existing agents in regard to 'sustained clinical response'; or (3) be priced at a reasonable cost when it comes to market or perhaps all three. Their utility can only be proven by clinical trials.

01 Sep 2018·The Lancet Infectious DiseasesQ1 · MEDICINE

Comparative efficacy of treatments for Clostridium difficile infection: a systematic review and network meta-analysis

Q1 · MEDICINE

Review

Author: Nicholas E Burr ; Tumas Beinortas ; Mark H Wilcox ; Venkataraman Subramanian

BACKGROUNDSeveral new treatments for Clostridium difficile infections have been investigated. We aimed to compare and rank treatments for non-multiply recurrent infections with C difficile in adults.METHODSWe did a random effects network meta-analysis within a frequentist setting to obtain direct and indirect comparisons of trials. We searched MEDLINE, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov for published and unpublished trials from the creation of these databases until June 30, 2017. We included randomised controlled trials of treatments for non-multiply recurrent infections with confirmed C difficile in adults (at least 18 years) that reported both primary cure and recurrence rates, and we used the Cochrane Risk of Bias tool to appraise trial methods. For our analysis, we extracted the total numbers of patients with primary cure and recurrence from published and unpublished reports. The primary outcome was sustained symptomatic cure, defined as the number of patients with resolution of diarrhoea minus the number with recurrence or death.FINDINGSOf 23 004 studies screened, 24 trials, which comprised 5361 patients and 13 different treatments, were included in the analysis. The overall quality of evidence was rated as moderate to low. For sustained symptomatic cure, fidaxomicin (odds ratio 0·67, 95% CI 0·55-0·82) and teicoplanin (0·37, 0·14-0·94) were significantly better than vancomycin. Teicoplanin (0·27, 0·10-0·70), ridinilazole (0·41, 0·19-0·88), fidaxomicin (0·49, 0·35-0·68), surotomycin (0·66, 0·45-0·97), and vancomycin (0·73, 0·56-0·95) were better than metronidazole. Bacitracin was inferior to teicoplanin (0·22, 0·06-0·77) and fidaxomicin (0·40, 0·17-0·94), and tolevamer was inferior to all drugs except for LFF571 (0·50, 0·18-1·39) and bacitracin (0·67, 0·28-1·58). Global heterogeneity of the entire network was low (Cochran's Q=15·70; p=0·47).INTERPRETATIONAmong the treatments for non-multiply recurrent infections by C difficile, the highest quality evidence indicates that fidaxomicin provides a sustained symptomatic cure most frequently. Fidaxomicin is a better treatment option than vancomycin for all patients except those with severe infections with C difficile and could be considered as a first-line therapy. Metronidazole should not be recommended for treatment of C difficile.FUNDINGNone.

100 Deals associated with LFF-571

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Clostridium difficile infection	Phase 2	CA	Novartis Pharmaceuticals Corp.	01 Oct 2010
Clostridium difficile infection	Phase 2	US	Novartis Pharmaceuticals Corp.	01 Oct 2010

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01232595 (Pubmed \| Antimicrob Agents Chemother) Manual	Phase 2	Clostridium difficile infection	72	LFF571	(qwbqpqufjd) = xxpwczthmk jxapnrvqsz (petxzyvbsy ) View more	Positive	01 Mar 2015
				vancomycin	(qwbqpqufjd) = xucxnhqskw jxapnrvqsz (petxzyvbsy ) View more
NCT01232595 (Pubmed \| Antimicrob Agents Chemother)	Phase 2	Clostridium difficile infection	109	LFF571 200 mg	molnbnlgpq(tmcoppugxf) = lqmoubpnrp secaftehkt (qyiyxfdekb )	-	01 Mar 2015
				Vancomycin 125 mg	molnbnlgpq(tmcoppugxf) = tqgfanqlmp secaftehkt (qyiyxfdekb )

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