A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Single Dose of ASN100 for the Prevention of Staphylococcus Aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects

The purpose of this study is the prevention of Staphylococcus aureus pneumonia in mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis. Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is an investigational monoclonal antibody product that targets the toxins produced by S. aureus to protect subjects from developing S. aureus pneumonia.

Start Date01 Nov 2016

Sponsor / Collaborator

Arsanis, Inc.

100 Clinical Results associated with Atidortoxumab/Berlimatoxumab

100 Translational Medicine associated with Atidortoxumab/Berlimatoxumab

100 Patents (Medical) associated with Atidortoxumab/Berlimatoxumab

Literatures (Medical) associated with Atidortoxumab/Berlimatoxumab

01 Aug 2019·Antimicrobial Agents and Chemotherapy

Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study of the Penetration of a Monoclonal Antibody Combination (ASN100) Targeting Staphylococcus aureus Cytotoxins in the Lung Epithelial Lining Fluid of Healthy Volunteers

Article

Author: Schwameis, Michael ; Magyarics, Zoltan ; Derhaschnig, Ulla ; Campanaro, Ed ; Stevens, Chris ; Lagler, Heimo ; Rouha, Harald ; Stiebellehner, Leopold ; Firbas, Christa ; Leslie, Fraser ; Bartko, Johann ; Luperchio, Steven ; Jilma, Bernd ; Schörgenhofer, Christian ; Nagy, Eszter ; Weber, Susanne

ASN100 is a novel antibody combination of two fully human IgG1(κ) monoclonal antibodies (MAbs), ASN-1 and ASN-2, which neutralize six Staphylococcus aureus cytotoxins, alpha-hemolysin (Hla) and five bicomponent leukocidins. We assessed the safety, tolerability, and serum and lung pharmacokinetics of ASN100 in a randomized, double-blind, placebo-controlled single-dose-escalation first-in-human study.

Scientific ReportsQ3 · CROSS-FIELD

Preventing lung pathology and mortality in rabbit Staphylococcus aureus pneumonia models with cytotoxin-neutralizing monoclonal IgGs penetrating the epithelial lining fluid

Q3 · CROSS-FIELD

ArticleOA

Author: Labrousse, Delphine ; Nagy, Eszter ; Glojnarić, Ines ; Maierhofer, Barbara ; Stulik, Lukas ; Badarau, Adriana ; Weber, Susanne ; Kramarić, Miroslava Dominis ; Groß, Karin ; Visram, Zehra Claire ; Rouha, Harald ; Nagy, Gábor ; Croisier, Delphine

AbstractStaphylococcus aureus pneumonia is associated with high mortality irrespective of antibiotic susceptibility. Both MRSA and MSSA strains produce powerful cytotoxins: alpha-hemolysin(Hla) and up to five leukocidins – LukSF-PV, HlgAB, HlgCB, LukED and LukGH (LukAB) – to evade host innate defense mechanisms. Neutralizing cytotoxins has been shown to provide survival benefit in rabbit S. aureus pneumonia models. We studied the mechanisms of protection of ASN100, a combination of two human monoclonal antibodies (mAbs), ASN-1 and ASN-2, that together neutralize Hla and the five leukocidins, in rabbit MRSA and MSSA pneumonia models. Upon prophylactic passive immunization, ASN100 displayed dose-dependent increase in survival and was fully protective against all S. aureus strains tested at 5 or 20 mg/kg doses. Macroscopic and microscopic lung pathology, edema rate, and bacterial burden were evaluated 12 hours post infection and reduced by ASN100. Pharmacokinetic analysis of ASN100 in bronchoalveolar-lavage fluid from uninfected animals detected efficient penetration to lung epithelial lining fluid reaching peak levels between 24 and 48 hours post dosing that were comparable to the mAb concentration measured in serum. These data confirm that the ASN100 mAbs neutralize the powerful cytotoxins of S. aureus in the lung and prevent damage to the mucosal barrier and innate immune cells.

100 Deals associated with Atidortoxumab/Berlimatoxumab

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pneumonia, Staphylococcal	Phase 2	FR	Arsanis, Inc.	01 Nov 2016
Pneumonia, Staphylococcal	Phase 2	UA	Arsanis, Inc.	01 Nov 2016
Pneumonia, Staphylococcal	Phase 2	HU	Arsanis, Inc.	01 Nov 2016
Pneumonia, Staphylococcal	Phase 2	GE	Arsanis, Inc.	01 Nov 2016
Pneumonia, Staphylococcal	Phase 2	RO	Arsanis, Inc.	01 Nov 2016
Pneumonia, Staphylococcal	Phase 2	CZ	Arsanis, Inc.	01 Nov 2016
Pneumonia, Staphylococcal	Phase 2	RS	Arsanis, Inc.	01 Nov 2016
Pneumonia, Staphylococcal	Phase 2	IN	Arsanis, Inc.	01 Nov 2016
Pneumonia, Staphylococcal	Phase 2	RU	Arsanis, Inc.	01 Nov 2016
Pneumonia, Staphylococcal	Phase 2	US	Arsanis, Inc.	01 Nov 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02940626 (CTgov)	Phase 2	Pneumonia, Ventilator-Associated \| Pneumonia, Staphylococcal	155	ASN100 (ASN100)	dcjnaxbojt(vwikgticgk): P-Value = 0.5470	-	31 Jul 2019
				Placebo (Placebo)

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Atidortoxumab/Berlimatoxumab

Overview

Basic Info

Gene Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation