Delving into the Latest Updates on VP-20621 with Synapse

Overview

Basic Info

Drug Type

Live biotherapeutic products

Synonyms

CDAD therapies, NTCD, NTX

+ [4]

Target-

Action

modulators

Mechanism

Bacteria replacements, Microbiome modulators

Therapeutic Areas

Infectious Diseases

Active Indication

Clostridium Infections

Inactive Indication

Clostridium difficile infection

Originator Organization

Edward Hines, Jr. VA Hospital

Active Organization

Edward Hines, Jr. VA Hospital

Inactive Organization

Shire Plc

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.

Start Date27 Jun 2011

Sponsor / Collaborator

Shire Plc

100 Clinical Results associated with VP-20621

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100 Translational Medicine associated with VP-20621

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100 Patents (Medical) associated with VP-20621

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18

Literatures (Medical) associated with VP-20621

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.

01 Feb 2024·Journal of Ocular Pharmacology and Therapeutics

Improved Topical Ophthalmic Natamycin Suspension for the Treatment of Fungal Keratitis

Article

Author: Cai, Chuntian ; Dudhipala, Narendar ; Joshi, Poorva H. ; Majumdar, Soumyajit ; Youssef, Ahmed Adel Ali ; Varner, Corinne

Purpose: Natamycin (NT) is used as a first-line antifungal prescription in the treatment of fungal keratitis (FK) and is commercially available as a 5% w/v ophthalmic suspension. NT shows poor water solubility and light sensitivity. Thus, the present investigation is aimed to enhance the fraction of NT in solution in the commercial formulation by adding cyclodextrins (CDs), thereby improving the delivery of the drug into deeper ocular tissues. Methods: The solubility of NT in different CDs, the impact of ultraviolet (UV) light exposure, stability at 4°C and 25°C, in vitro release, and ex vivo transcorneal permeation studies were performed. Results: NT exhibited the highest solubility (66-fold) in randomly methylated-β-cyclodextrin (RM-βCD) with hydroxypropyl-βCD (HP-βCD) showing the next highest solubility (54-fold) increase in comparison to market formulation Natacyn^® as control. The stability of NT-CD solutions was monitored for 2 months (last-time point) at both storage conditions. The degradation profile of NT in NT-RM-βCD and NT-HP-βCD solutions under UV-light exposure followed first-order kinetics exhibiting half-lives of 1.2 h and 1.4 h, respectively, an almost 3-fold increase over the control solutions. In vitro release/diffusion studies revealed that suspensions containing RM-βCD and HP-βCD increased transmembrane flux significantly (3.1-fold) compared to the control group. The transcorneal permeability of NT from NT-RM-βCD suspension exhibited an 8.5-fold (P < 0.05) improvement compared to Natacyn eyedrops. Furthermore, the addition of RM-βCD to NT suspension increases the solubilized fraction of NT and enhances transcorneal permeability. Conclusion: Therefore, NT-RM-βCD formulations could potentially lead to a decreased frequency of administration and significantly improved therapeutic outcomes in FK treatment.

01 Jun 2022·Early Human Development

Effects of Omega-3-6-9 fatty acid supplementation on behavior and sleep in preterm toddlers with autism symptomatology: Secondary analysis of a randomized clinical trial

Article

Author: Rogers, Lynette K ; Rausch, Joseph ; Boone, Kelly M ; Keim, Sarah A ; Klebanoff, Mark A ; Coury, Daniel L

BACKGROUNDChildren born extremely preterm disproportionately experience sequelae of preterm birth compared to those born at later gestational ages, including higher prevalence of autism spectrum disorder (ASD) and associated behaviors.AIMExplore effects of combined dietary docosahexaenoic acid, eicosapentaenoic acid, gamma-linolenic acid, and oleic acid (omega 3-6-9) on caregiver-reported behavior and sleep in toddlers born at ≤29 weeks' gestation who were exhibiting symptoms commonly seen with ASD.STUDY DESIGN90-day randomized (1:1), double blinded, placebo-controlled trial.SUBJECTSThirty-one children aged 18-38 months received omega 3-6-9 (n = 15) or canola oil placebo (n = 16).OUTCOME MEASURESMixed effects regression analyses followed intent to treat and explored treatment effects on measures of caregiver-reported behavior (Child Behavior Checklist 1.5-5, Toddler Behavior Assessment Questionnaire - Short Form, Vineland Adaptive Behavior Scales, 2nd Edition) and sleep (Children's Sleep Habits Questionnaire, Brief Infant Sleep Questionnaire).RESULTSTwenty-nine of 31 (94%; n_tx = 13, n_placebo = 16) children randomized had data available for at least one outcome measure, 27 (87%; n_tx = 12, n_placebo = 15) had complete outcome data. Children randomized to omega 3-6-9 experienced a medium magnitude benefit of supplementation on anxious and depressed behaviors (Δ_Difference = -1.27, d = -0.58, p = 0.049) and internalizing behaviors (Δ_Difference = -3.41, d = -0.68, p = 0.05); and a large magnitude benefit on interpersonal relationship adaptive behaviors (Δ_Difference = 7.50, d = 0.83, p = 0.01), compared to placebo. No effects were observed on other aspects of behavior or sleep.CONCLUSIONSFindings provide preliminary support for further exploration of omega 3-6-9 during toddlerhood to improve socioemotional outcomes among children born preterm, especially for those showing early symptoms commonly seen with ASD. Results need to be replicated in a larger sample.TRIAL REGISTRATIONRegistered with ClinicalTrials.gov: NCT01683565.

100 Deals associated with VP-20621

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Clostridium Infections	Phase 2	-	Edward Hines, Jr. VA Hospital	-
Clostridium difficile infection	Discovery	Switzerland	Shire Plc	27 Jun 2011
Clostridium difficile infection	Discovery	Spain	Shire Plc	27 Jun 2011
Clostridium difficile infection	Discovery	United States	Shire Plc	27 Jun 2011
Clostridium difficile infection	Discovery	Belgium	Shire Plc	27 Jun 2011
Clostridium difficile infection	Discovery	Germany	Shire Plc	27 Jun 2011
Clostridium difficile infection	Discovery	Canada	Shire Plc	27 Jun 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DDW2023	Not Applicable	Inflammation	-	NTX-1175 50 mg/kg	ansaptjkzw(lxbfzwlnuw) = akjuzcxvvp kdsapnfxlm (yomptlpmac )	-	09 May 2023
				Vehicle	ansaptjkzw(lxbfzwlnuw) = qaoejuwwrh kdsapnfxlm (yomptlpmac )
NCT01259726 (Pubmed \| J Coll Physicians Surg Pak \| JAMA) Manual	Phase 2	Clostridium difficile infection	168	nontoxigenic Clostridium difficile strain M3	(vuiczdnuwz) = wmqjdayqen uepiolfggz (netkurnajb ) View more	Positive	05 May 2015
				Placebo	(vuiczdnuwz) = nhkvtsnrdn uepiolfggz (netkurnajb ) View more
NCT01259726 (CTgov)	Phase 2	Clostridium difficile infection	173	Placebo	vfieltufjm(ktkjtwcekb) = dpfzohkuao vmerhegpor (wfcvtqtngx, usblqlmqsp - seipidberg) View more	-	12 Feb 2015