Delving into the Latest Updates on Mibenratide with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Target

β1-adrenergic receptor

Mechanism

β1-adrenergic receptor antagonists(Beta-1 adrenergic receptor antagonists)

Therapeutic Areas

Cardiovascular DiseasesOther Diseases

Active Indication-

Inactive Indication

Cardiomyopathy, DilatedHeart Failure

Originator Organization

Johnson & Johnson

Active Organization-

Inactive Organization

Corimmun GmbHJanssen Research & Development LLC

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Structure

Molecular FormulaC87H129N27O30S2

InChIKeyCQXYENUJCPYPTI-LZUXSVOASA-N

CAS Registry1239011-83-6

Gene Sequence

Sequence Code 537343084

Source: *****

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of JNJ-54452840 in participants with heart failure and anti-beta1-adrenergic receptor autoantibodies. The safety and tolerability of JNJ-54452840 will also be assessed.

Start Date01 Nov 2014

Sponsor / Collaborator

Janssen Research & Development LLC

NCT01809353 / CompletedPhase 1

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Pharmacokinetics and Safety of JNJ-54452840 Following Single Intravenous Doses to Healthy Japanese and Caucasian Subjects

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and safety of JNJ-54452840 in healthy participants.

Start Date01 Jul 2013

Sponsor / Collaborator

Janssen Research & Development LLC

NCT01902550 / WithdrawnPhase 1

A Randomized, Double-Blind, 2-Period Crossover Study to Evaluate the Effect of Single Dose JNJ-54452840 on Pharmacodynamics of Metoprolol Tartrate Immediate-Release in Healthy Subjects

The purpose of this study is to evaluate effect of co-administration of JNJ-54452840 and metoprolol tartrate immediate-release (metoprolol IR) compared to metoprolol IR alone on the exercise heart rate and blood pressure measured at the end of each 3-minute exercise test in healthy participants.

Start Date01 Jul 2013

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with Mibenratide

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100 Translational Medicine associated with Mibenratide

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100 Patents (Medical) associated with Mibenratide

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7

Literatures (Medical) associated with Mibenratide

01 Dec 2016·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1

Q3 · MEDICINE

Article

Author: Dutton, Julie L. ; Griffin, Paul ; Woo, Wai-Ping ; Li, Bo ; Finlayson, Neil ; Frazer, Ian H. ; Chandra, Janin ; Xu, Yan

This paper describes a single site, open-label Phase I clinical trial evaluating the safety, tolerability and immunogenicity in healthy volunteers of a herpes simplex polynucleotide vaccine that has previously been shown to enhance immunogenicity and protect against lethal herpes simplex virus type 2 (HSV-2) challenge in mice. Five escalating doses of the vaccine, COR-1, were given by intradermal injection to HSV-1 and 2 seronegative healthy individuals. COR-1 was found to be safe and well-tolerated; the only vaccine-related adverse events were mild. While vaccine-induced antibody responses were not detectable, cell-mediated immune responses to HSV-specific peptide groups were identified in 19 of the 20 subjects who completed the study, and local inflammation at the immunisation site was observed. This study indicates COR-1 has potential to be used as a therapeutic vaccine for HSV-2 infection.

01 Mar 2016·Future Cardiology

Naltrexone/bupropion for the Treatment of Obesity and Obesity With Type 2 Diabetes

Review

Author: Apovian, Caroline M

Contrave® is a combination of naltrexone hydrochloride extended release and bupropion hydrochloride extended release for the treatment of obesity, and is used with lifestyle modification. Its safety and efficacy were assessed in four randomized, double-blind, placebo-controlled, 56-week Phase III clinical trials in 4536 adult subjects: COR-1, COR-II, COR-BMOD and COR-DM. All four studies demonstrated statistically significant and clinically meaningful weight loss following up to 52 weeks of treatment with naltrexone/bupropion compared with placebo. The average weight loss from baseline across the four studies was approximately 11–22 lbs (5–9 kg). Results show the efficacy of Contrave for weight loss, as well as significant improvements in cardiometabolic markers. This review focuses on the four studies, their outcomes and the mechanism of action of Contrave.

01 Feb 2016·Clinical PharmacokineticsQ2 · MEDICINE

Pharmacokinetics and Safety of Single Intravenous Doses of JNJ-54452840, an Anti-β1-Adrenergic Receptor Antibody Cyclopeptide, in Healthy Male Japanese and Caucasian Participants

Q2 · MEDICINE

Article

Author: Kojak, Clare ; De Vries, Ronald ; Plotnikov, Alexei H ; Vutikullird, Apinya ; Ariyawansa, Jay ; Davies, Brian E ; Johnson, Maureen ; Peters, Gary ; Nnane, Ivo P

AIMTo evaluate the pharmacokinetics and safety of single intravenous doses of JNJ-54452840 infused over 1 minute in healthy male Japanese and Caucasian participants. JNJ-54452840 is a novel peptide for the treatment of chronic heart failure, with a proposed mechanism of action of binding interference and decreased production of anti-β1-adrenergic receptor (anti-β1-AR) antibodies, which stimulate the cardiac β1-AR.METHODSIn this randomized, single-centre, double-blind, placebo-controlled, four-way crossover study, 32 male Japanese and Caucasian participants (16 in each group) received single intravenous doses of JNJ-54452840 20, 80 and 240 mg, and placebo, each separated by a ≥7-day washout period. Pharmacokinetics and safety were assessed predose and at specified timepoints for 24 h. Anti-β1-AR antibodies were monitored.RESULTSThe mean JNJ-54452840 maximum observed plasma concentration (C max) and area under the concentration-time curve from time zero to infinity with extrapolation of the terminal phase (AUCinf) values increased linearly with dose, with rapid elimination in both groups. Dose proportionality criteria were not met between the 20 and 240 mg doses for both study cohorts. The median time to reach C max (T max) ranged from 1 to 5 minutes. The mean total systemic clearance after intravenous administration (CL), volume of distribution at steady state (V ss), mean residence time (MRT) and terminal half-life (T ½) values were similar for both groups. The mean T ½ values ranged from 5.9 to 26.1 min in a dose-dependent manner. The overall prevalence of antibodies was 9.4 % at baseline; antibodies not present at baseline developed in five Caucasians (15.6 %) but not in Japanese participants. One participant in each group experienced a serious thromboembolic event (pulmonary embolism, ischaemic stroke).CONCLUSIONJNJ-54452840 demonstrated similar pharmacokinetics in both groups. JNJ-54452840 was possibly immunogenic, and two participants reported thromboembolic serious adverse events. The relationship between these events and antibody formation is not known.

100 Deals associated with Mibenratide

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cardiomyopathy, Dilated	Phase 2	DE	Corimmun GmbH	01 Oct 2011
Heart Failure	Phase 2	DE	Corimmun GmbH	01 Oct 2011
Heart Failure	Phase 2	DE	Corimmun GmbH	01 Oct 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01391507 (CTgov)	Phase 2	Cardiomyopathy, Dilated \| Heart Failure	36	Standard therapy for heart failure	vdejldsmhe(eehsdsseto) = gbnwiukotp ieriairtah (zqlqiwljwe, ggpnjgqiif - oqwffemqkn) View more	-	26 Aug 2014