A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Faldaprevir and TD 6450 Alone and in Combination With Other Antivirals for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 1 Hepatitis C Virus

Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.

Start Date01 May 2016

Sponsor / Collaborator

Trek Therapeutics PBCStartup

NCT02593162 / CompletedPhase 2

Phase 2a, Randomized, Double-Blind Study to Investigate the Safety and Efficacy of Faldaprevir in Combination With Ribavirin and TD-6450 for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 4 Hepatitis C Virus

Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 in combination with Ribavirin for a 12-week treatment duration in treatment-naïve participants with genotype 4 hepatitis C virus (HCV) infection.

Start Date01 Oct 2015

Sponsor / Collaborator

Trek Therapeutics PBCStartup

NCT02116543 / CompletedPhase 1

A Double-Blinded, Randomized, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Activity of TD-6450, a NS5A Inhibitor, in Treatment Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.

Start Date01 May 2014

Sponsor / Collaborator

Theravance Biopharma, Inc.

100 Clinical Results associated with TD-6450

100 Translational Medicine associated with TD-6450

100 Patents (Medical) associated with TD-6450

Literatures (Medical) associated with TD-6450

07 Apr 2023·Nature communicationsQ1 · CROSS-FIELD

Safe drugs with high potential to block malaria transmission revealed by a spleen-mimetic screening.

Q1 · CROSS-FIELD

ArticleOA

Author: Gamo, Francisco Javier ; Tarning, Joel ; Buffet, Pierre ; Ndour, Papa Alioune ; Roussel, Camille ; Dumas, Lucie ; Sissoko, Abdoulaye ; Duez, Julien ; Beher, Babette ; Amireault, Pascal ; Gamallo, Pablo ; McNamara, Case W ; Dussiot, Michael ; Hull, Mitchell V ; Fricot-Monsinjon, Aurélie ; Carucci, Mario ; Sanz, Laura Maria ; García-Barbazán, Irene ; Dao, Ming

Malaria parasites like Plasmodium falciparum multiply in red blood cells (RBC), which are cleared from the bloodstream by the spleen when their deformability is altered. Drug-induced stiffening of Plasmodium falciparum-infected RBC should therefore induce their elimination from the bloodstream. Here, based on this original mechanical approach, we identify safe drugs with strong potential to block the malaria transmission. By screening 13 555 compounds with spleen-mimetic microfilters, we identified 82 that target circulating transmissible form of P. falciparum. NITD609, an orally administered PfATPase inhibitor with known effects on P. falciparum, killed and stiffened transmission stages in vitro at nanomolar concentrations. Short exposures to TD-6450, an orally-administered NS5A hepatitis C virus inhibitor, stiffened transmission parasite stages and killed asexual stages in vitro at high nanomolar concentrations. A Phase 1 study in humans with a primary safety outcome and a secondary pharmacokinetics outcome ( https://clinicaltrials.gov , ID: NCT02022306) showed no severe adverse events either with single or multiple doses. Pharmacokinetic modelling showed that these concentrations can be reached in the plasma of subjects receiving short courses of TD-6450. This physiologically relevant screen identified multiple mechanisms of action, and safe drugs with strong potential as malaria transmission-blocking agents which could be rapidly tested in clinical trials.

100 Deals associated with TD-6450

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis C	Phase 2	-	Theravance Biopharma, Inc.	-
Chronic hepatitis C genotype 1b	Discovery	US	Trek Therapeutics PBCStartup	01 May 2016
Chronic hepatitis C genotype 1b	Discovery	NZ	Trek Therapeutics PBCStartup	01 May 2016
Chronic hepatitis C genotype 3	Discovery	US	Theravance Biopharma, Inc.	01 May 2014
Mandibuloacral Dysplasia With Type a Lipodystrophy	Discovery	US	Theravance Biopharma, Inc.	01 Feb 2014
Seasonal Affective Disorder	Discovery	US	Theravance Biopharma, Inc.	01 Feb 2014

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