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sulopenem and PF-03709270

Phase 2

Pneumonia, Bacterial | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Mar 10, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00797108A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires HospitalizationPHASE2 COMPLETED 35Jan 1, 2009Jun 1, 2009Mar 10, 201624 United States, Australia +3
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Study Endpoints
Primary Endpoints
Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit
7 to 14 days after end of treatment

Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At TOC (7 to 14 days after end of treatment \[EOT\]) CR was evaluated as "cure"=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; "failure"=persistence or progression of baseline signs and symptoms of pneumonia (for example: body temperature, white blood cell \[WBC\] count, respiratory rate, auscultatory findings, cough, sputum production), development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; "indeterminate"=extenuating circumstances precluded classification to 1 of the above.

Secondary Endpoints
Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit
EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT)
Number of Participants With Microbiological Response at Test of Cure (TOC) Visit
7 to 14 days after EOT
Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit
Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALLoading dose of IV sulopenem with switch to oral PF-03709270
2EXPERIMENTALIV sulopenem with switch to oral PF-03709270
3ACTIVE_COMPARATORIV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator
Interventions
NameTypeDescription
sulopenem and PF-03709270DRUGSulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day
Ceftriaxone and amoxicillin/clavulanateDRUGIV ceftriaxone (2g) infused over 30 minutes QD (once daily) for minimum of 2 days Step down oral amoxicillin/clavulanate potassium suspension (400 mg/5 ml) BID (every 12 hours)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Hospitalized male or female patients 18 years of age or older. * Female patients of childbearing potential must not be pregnant. * Must exhibit at least two pre-specified clinical symptoms/signs of pneumonia. * Must require hospitalization for the pneumonia. * Chest Xray must ...

Countries:United StatesAustraliaCanadaPolandSouth Korea
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