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First-in-human study of MW151, a novel drug targeting neuroinflammation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44AG060846-01
Agency Tracking Number: R44AG060846
Amount: $499,320.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PAS17-064
Timeline
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-30
Award End Date (Contract End Date): 2019-05-31
Small Business Information
105 AUBRUN ST
Newton, MA 02466-2524
United States
DUNS: 080178314
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 VICTOR SHIFRIN
 (617) 872-0639
 shifrin.victor@gmail.com
Business Contact
 VICTOR SHIFRIN
Phone: (617) 872-0639
Email: vshifrin@ic-rx.com
Research Institution
N/A
Abstract

ABSTRACT
Alzheimerandapos s diseaseADis one of the largest global public health crises facing us todayyet there are no
effective therapies available to preventdelayor slow AD progressionDominant approaches based on a set of
prevailing core hypotheses about druggable pathways and targets have failedThereforethere is a need for
novel and alternative pathways distinct from those pursued over the past two decadesOur strategy is to target a
particular form of dysregulated neuroinflammationinjurious proinflammatory cytokine overproduction that is a
key contributor to synaptic dysfunctionneurodegeneration and cognitive decline in diverse neurodegenerative
diseasesWe seek Fast Track SBIR funding for a first in humanFIHstudy of MWSRMMWa
novelCNS penetrantorally bioavailablesmall molecule drug candidate that selectively suppresses stressorinduced proinflammatory cytokine overproductionMWameliorates synaptic damage and cognitive
impairment at low doses in diverse animal models where proinflammatory cytokine dysregulation is established
as a contributor to neurologic injury or susceptibility to neurologic injuryMWis chemically and
metabolically stabilehas no liabilities in investigational new drugINDenabling safety pharmacology and
toxicology screens following ICH FDA guidanceThese include respiratory and cardiovascular safety
pharmacology screensrat and dogday repeat administration toxicology studiesand genotox analysesFurthera MWanalog developed for the more demanding i vroute of administration has been substantially
de risked in a phaseb clinical trialOverallMWis a highly de risked and promising candidate for clinical
development as an oral formulation for the treatment of AD or related disordersAimPrepare regulatory and other processes for a FIH SAD trialThe tasks include preparation and
regulatory approval of required clinical trial documentsand the validation of methods for measurement of
MWin human plasmaAimConduct a single ascending doseSADphasea trial of MWThe SAD study will determine safety
and tolerability and maximum tolerated dose of MWas well as its pharmacokineticPKprofile in a SAD
paradigm in healthy adult volunteersPlasma cytokine levels will be measured to provide baseline data for a
future exploratory pharmacodynamicPDendpoint in phaseba clinical trialsAimPrepare regulatory and other processes for a multiple ascending doseMADphaseb trialWe will
design a multiple ascending doseMADclinical study of MWin healthy volunteersincluding a cohort of
elderly healthy subjectsThis project will advance clinical development of a promising drug candidate that could have disease modifying
effects not only in AD but also in a number of other CNS disorders where proinflammatory cytokine
dysregulation is part of the pathophysiology progression mechanism NARRATIVE
Our project addresses an urgent and critically important priority of the National Plan to Address Alzheimer s
Diseaseto develop effective disease modifying therapies to preventdelayor treat Alzheimer s diseaseWe
are developing a promising small molecule drug candidate that targets detrimental brain inflammation and that
attenuates cognitive impairment and disease progression in Alzheimer s animal modelsOur proposed study
will perform the first human trial of this new drugto demonstrate safety in healthy adults as a prerequisite for
future trials in elderly individuals with cognitive impairment

* Information listed above is at the time of submission. *

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