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 ; Campanaro, Ed ; Derhaschnig, Ulla ; Stevens, Chris ; Rouha, Harald ; Lagler, Heimo ; Stiebellehner, Leopold ; Firbas, Christa ; Leslie, Fraser ; Luperchio, Steven ; Bartko, Johann ; 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 ; Badarau, Adriana ; Maierhofer, Barbara ; Stulik, Lukas ; Kramarić, Miroslava Dominis ; Weber, Susanne ; 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

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Indication	Highest Phase	Country/Location	Organization	Date
Pneumonia, Ventilator-Associated	Phase 2	Czechia	Arsanis, Inc.	01 Nov 2016
Pneumonia, Ventilator-Associated	Phase 2	Ukraine	Arsanis, Inc.	01 Nov 2016
Pneumonia, Ventilator-Associated	Phase 2	Serbia	Arsanis, Inc.	01 Nov 2016
Pneumonia, Ventilator-Associated	Phase 2	France	Arsanis, Inc.	01 Nov 2016
Pneumonia, Ventilator-Associated	Phase 2	Romania	Arsanis, Inc.	01 Nov 2016
Pneumonia, Ventilator-Associated	Phase 2	South Africa	Arsanis, Inc.	01 Nov 2016
Pneumonia, Ventilator-Associated	Phase 2	Russia	Arsanis, Inc.	01 Nov 2016
Pneumonia, Ventilator-Associated	Phase 2	Portugal	Arsanis, Inc.	01 Nov 2016
Pneumonia, Ventilator-Associated	Phase 2	Austria	Arsanis, Inc.	01 Nov 2016
Pneumonia, Ventilator-Associated	Phase 2	United States	Arsanis, Inc.	01 Nov 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


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

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