Evidence map›Paper›PMID 35227115›Full record

ArticleInternational journal of toxicology

Investigational New Drug Enabling Nonclinical Safety Pharmacology Assessment of the Iminosugar UV-4, a Broad-Spectrum Host-Targeted Antiviral Agent.

Jeffry Shearer, Gary Wolfe, Aruna Sampath, Kelly L Warfield, Brian Kaufman, Urban Ramstedt, Anthony Treston

Open access · greenAbstract read
In one paragraph

Article in International journal of toxicology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.3field-weighted citation impact, top 51% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 3 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Jeffry Shearer61424Emergent BioSolutions Inc, Gaithersburg, MD, USA.
Gary WolfeGary Wolfe Toxicology LLC, Herndon, VA, USA.
Aruna Sampath61424Emergent BioSolutions Inc, Gaithersburg, MD, USA.
Kelly L Warfield61424Emergent BioSolutions Inc, Gaithersburg, MD, USA.ORCID 0000-0003-1866-5388
Brian Kaufman61424Emergent BioSolutions Inc, Gaithersburg, MD, USA.
Urban Ramstedt61424Emergent BioSolutions Inc, Gaithersburg, MD, USA.
Anthony Treston61424Emergent BioSolutions Inc, Gaithersburg, MD, USA.ORCID 0000-0001-7497-8253
Emergent BioSolutions (United States) · USDynavax Technologies (United States) · US

Funding

NIAID NIH HHS HHSN272201100030C
6 · The paper itself

Abstract

UV-4 (N-(9-methoxynonyl)-1-deoxynojirimycin) is a broad-spectrum antiviral drug candidate with demonstrated activity in vitro and in vivo against multiple, diverse viruses. Nonclinical safety pharmacology studies were conducted to support the filing of an Investigational New Drug (IND) application. Preliminary in vitro pharmacology testing evaluating potential for binding to "off-target" receptors and enzymes indicated no significant liability for advanced development of UV-4. The safety pharmacology of UV-4 was evaluated in the in vitro human ether-à-go-go-related gene (hERG) assay, in a central nervous system (CNS) study in the mouse (modified Irwin test), in a respiratory safety study in conscious mice using whole body plethysmography, and in a cardiovascular safety study in conscious, radiotelemetry-instrumented beagle dogs. There were no observed adverse treatment-related effects following administration of UV-4 as the hydrochloride salt in the hERG potassium channel assay, on respiratory function, in the CNS study, or in the cardiovascular assessment. Treatment-related cardiovascular effect of decreased arterial pulse pressure after 50 or 200 mg of UV-4/kg was the only change outside the normal range, and all hemodynamic parameters returned to control levels by the end of the telemetry recording period. These nonclinical safety pharmacology assessments support the evaluation of this host-targeted broad-spectrum antiviral drug candidate in clinical studies.

Indexed as

Cardiovascular SystemDrug-Related Side Effects and Adverse ReactionsAnimalsAntiviral AgentsDogsDrug Evaluation, PreclinicalDrugs, InvestigationalMiceTelemetryAntiviral AgentsDrugs, Investigationalcardiovascularhost-targeted antiviraliminosugarnervous systemrespiratorysafety pharmacologyUV-4

Identifiers

PMID35227115
PMCPMC9156554
OpenAlexW4214543767

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.