Delving into the Latest Updates on MEDI-8852 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Target

hemagglutinin

Mechanism

hemagglutinin modulators(Influenza virus hemagglutinin glycoproteins modulators)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza, Human

Inactive Indication

Influenza A virus infection

Originator Organization

Humabs BioMed SA

Active Organization

Humabs BioMed SA

Inactive Organization

MedImmune LLC

AstraZeneca PLC

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 4730175H

Sequence Code 173981L

The purposes of this study are to determine if MEDI8852 administered with standard of care (oseltamivir) will reduce the time to normalization of respiratory function for adults who are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an acceptable safety profile in adults who are hospitalized with influenza caused by Type A strains.

Start Date24 Jul 2017

Sponsor / Collaborator

MedImmune LLC

EUCTR2015-004276-29-IT / Not yet recruitingPhase 2

A Phase 2b, Randomized, Double-blind, Single-dose, Active-controlled,Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 inAdults who are Hospitalized with Influenza Caused by Type A Strains - A Phase 2b Study to Evaluate the Efficacy and Safety of MEDI8852 inAdults who are Hospitalized with

Start Date18 Jan 2017

Sponsor / Collaborator

MedImmune LLC

100 Clinical Results associated with MEDI-8852

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100 Translational Medicine associated with MEDI-8852

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100 Patents (Medical) associated with MEDI-8852

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6

Literatures (Medical) associated with MEDI-8852

25 Jul 2019·JCI InsightQ1 · MEDICINE

Survival during influenza-associated bacterial superinfection improves following viral- and bacterial-specific monoclonal antibody treatment

Q1 · MEDICINE

ArticleOA

Author: Tobin, Joshua M ; Ramanan, Krishnaveni ; Sellman, Bret R ; Robinson, Keven M ; Nickolich, Kara L ; Pilewski, Matthew J ; Alcorn, John F ; Kallewaard, Nicole L ; Cohen, Taylor S

Postinfluenza bacterial superinfections cause increased morbidity and mortality compared with singular infection with influenza during both pandemics and seasonal epidemics. Vaccines and current treatments provide limited benefit, a rationale to conduct studies utilizing alternative therapies. FY1 and an optimized version, MEDI8852, anti-influenza HA mAbs, have been shown to neutralize influenza virus during singular influenza infection. MEDI4893*, an anti-Staphylococcus aureus α-toxin mAb, has been shown to improve survival when administered prophylactically prior to S. aureus pneumonia. Our objective was to determine if mAbs can improve survival during postinfluenza bacterial pneumonia. We administered FY1 in a murine model of postinfluenza methicillin-resistant S. aureus (MRSA) pneumonia and observed improved survival rates when given early during the course of influenza infection. Our findings indicate decreased lung injury and increased uptake and binding of bacteria by macrophages in the mice that received FY1 earlier in the course of influenza infection, corresponding to decreased bacterial burden. We also observed improved survival when mice were treated with a combination of FY1 and MEDI4893* late during the course of postinfluenza MRSA pneumonia. In conclusion, both FY1 and MEDI4893* prolong survival when used in a murine model of postinfluenza MRSA pneumonia, suggesting pathogen-specific mAbs as a possible therapeutic in the context of bacterial superinfection.

01 Nov 2018·Antimicrobial Agents and ChemotherapyQ2 · MEDICINE

Evaluation of MEDI8852, an Anti-Influenza A Monoclonal Antibody, in Treating Acute Uncomplicated Influenza

Q2 · MEDICINE

Article

Author: Shoemaker, Kathryn ; Nyborg, Andrew ; Dubovsky, Filip ; Ali, S. Omar ; Mallory, Raburn M. ; Takas, Therese ; Kallewaard, Nicole L. ; Chiong, Rafael

We evaluated MEDI8852, a human IgG1 monoclonal antibody that binds a highly conserved influenza A hemagglutinin stalk epitope, in outpatients with uncomplicated influenza A infection. A total of 126 subjects aged 18 to 65 years were enrolled during the 2015 to 2016 Northern and 2016 Southern Hemisphere seasons.

01 Nov 2017·BiologicalsQ4 · BIOLOGY

A phase 1 study to evaluate the safety and pharmacokinetics of MEDI8852, an anti-influenza A monoclonal antibody, in healthy adult volunteers

Q4 · BIOLOGY

Article

Author: Kankam, Martin ; Tseng, Leo ; Ali, S Omar ; Mallory, Raburn M ; Dubovsky, Filip ; Takas, Therese

MEDI8852 is an IgG1 kappa monoclonal antibody that is being developed to treat patients hospitalized with influenza A. We evaluated the safety and tolerability, pharmacokinetics, and anti-drug antibodies (ADA) of a single intravenous dose of MEDI8852 in healthy adult volunteers (NCT02350751). Forty subjects were randomized to receive either MEDI8852 (250, 750, 1,500, or 3000 mg) (n = 32) or placebo (n = 8) on day 1. Dose escalation was based on cumulative safety data through day 8. Subjects were followed through day 101 for safety, pharmacokinetics, and ADA. Treatment-emergent adverse events (TEAEs) were comparable (37.5%; 37.5%); all TEAEs were mild (grade 1) or moderate (grade 2) in severity. The most frequently reported TEAEs were headache (9.4%, 12.5%) and hypoglycemia (12.5%, 12.5%); all subjects with hypoglycemia were asymptomatic and did not require treatment. No subjects discontinued the study due to a TEAE. Mean area under the curve from time 0 to last sampling time point, area under the curve from time 0 to infinity, and observed maximum concentration for MEDI8852 were dose proportional. The terminal half-life ranged from 19.4 to 22.6 days. No ADAs were detected. A population pharmacokinetic model demonstrated good concentration separation between the 750- and 3000-mg dose groups.

100 Deals associated with MEDI-8852

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 2	-	Humabs BioMed SA	-
Influenza A virus infection	Preclinical	US	AstraZeneca PLC	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02603952 (Pubmed \| Antimicrob Agents Chemother) Manual	Phase 1/2	Influenza A virus infection	126	oseltamivir+MEDI8852	ofjjxymmdu(bprrnucswt) = jhxlnplveu trxgpapmgy (ugehmqzlwo ) View more	Positive	24 Oct 2018
				Placebo+oseltamivir	ofjjxymmdu(bprrnucswt) = kdfvlahvwu trxgpapmgy (ugehmqzlwo ) View more
NCT02603952 (MEDI8852, CTgov)	Phase 1/2	Influenza, Human	126	Placebo+Oseltamivir (Placebo + Oseltamivir 75 mg)	qmldfnwsvo(qypszjxprg) = nwmcncbxqg fukjxpsodc (mzfnugqjle, yfkjrfnfbb - utqbfnohut) View more	-	08 Jun 2018
				MEDI8852+Oseltamivir (MEDI8852 750 mg + Oseltamivir 75 mg)	qmldfnwsvo(qypszjxprg) = sronnnnjin fukjxpsodc (mzfnugqjle, ukiqwjgksp - cfigjuohcj) View more
NCT02350751 (Pubmed \| Biologicals) Manual	Phase 1	Influenza A virus infection	40	MEDI8852	(mdnseefgrr) = No subjects discontinued the study due to a TEAE. bkulzbyulx (ylvieeofms )	Positive	01 Nov 2017
				Placebo