Recent Updates
Recently added Catalysts

AR-105

Phase 2

Pseudomonas Aeruginosa Pneumonia | Small Molecules | Infectious Disease |Aridis Pharmaceuticals Inc.|Trials Updated: Mar 17, 2022

AR-105 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jan 2017

AR-105 target and mechanism

ModalitySmall Molecules

Also known as Aerubumab, Aerucin

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment158

FDA Designations

No designations recorded

AR-105 clinical trials

AR-105 · 1 trial · 1 indication

Phase 2 1
NCT03027609Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa PneumoniaPseudomonas Aeruginosa Pneumonia
COMPLETED158 Analytics
PHASE2COMPLETED
Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Pseudomonas Aeruginosa Pneumonia
NCT03027609158
Unlock trial analytics

Study Endpoints

Primary Endpoints

Clinical Cure on Day 21
21 days following dosing

A summary of the number (%) of patients who were cured on or before Day 21 (micro-ITT population) is provided, by treatment group

Secondary Endpoints

Clinical Cure on Day 7
7 days following dosing
Clinical Cure on Day 14
14 days following dosing
Clinical Cure on Day 28
28 days following dosing
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AR-105EXPERIMENTALOne intravenous infusion of AR-105 20mg/'kg
ControlPLACEBO_COMPARATORMatching placebo

Interventions

NameTypeDescription
AR-105DRUGmonoclonal antibody
PlaceboDRUGmatching placebo (+ SOC antibiotics)
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites111

Inclusion Criteria: * Informed consent * ≥18 years of age, ≥ 20 years of age (Taiwan only),≥ 19 (S. Korea only) * pneumonia due to P. aeruginosa * mechanically-ventilated * intubated * APACHE II score between 10 and 35 Exclusion Criteria (main criteria): * being moribund * effective antibiotic th...

Countries:United StatesAustraliaBelarusBelgiumCzechiaFranceGeorgiaGreeceHungaryMexicoPeruPolandRussiaSouth KoreaSpainTaiwanUkraine
Unlock Eligibility Criteria

Explore more on BiopharmaWatch

Aridis Pharmaceuticals Inc. (ARDS)Pipeline, catalysts, financials, insiders and newsBiotech disease mapWho is developing what in each indication, and how crowded it isFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with ACompanies A to ZEvery biotech and pharma company we track