1. Drug Development Coalition
CPTR Workshop October 3, 2012

2. CPTR Organization Regulatory Science Consortium
Integrated Sciences Team
Data Standards & Integration WG
Biomarkers & Clinical Endpoints WG
Preclinical & Clinical Sciences WG
Clinical Disease Progression Modeling WG
Health Authorities Submission WG
Clinical Trials Infrastructure WG
Regulatory Science Consortium
Research Resources Group
Global Regulatory Pathways WG
Stakeholder & Community Engagement WG
Access & Appropriate Use WG
Drug Development
Coalition
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3. Drug Development Coalition Signatories
AstraZeneca Bayer JNJ Sanofi TB Alliance WHO

4. Global TB Drug Pipeline
Discovery1
Preclinical Development
Clinical Development
Lead Optimization
Preclinical Development
GLP Tox.
Phase I
Phase II
Phase III
Diarylquinoline
InhA Inhibitors
LeuRS Inhibitors
Mycobacterial Gyrase
Inhibitors
Pyrazinamide Analogs
Riminophenazines
Ruthenium (II) complexes
Spectinamides
Translocase-1 Inhibitors
CPZEN-45
DC-159a
Q201
SQ609
SQ641
BTZ043
TBA-354
AZD5847
Bedaquiline (TMC-207)
Linezolid
Novel Regimens2
PA-824
Rifapentine
SQ-109
Sutezolid (PNU )
Delamanid (OPC-67683)
Gatifloxacin
Moxifloxacin
Rifapentine
Chemical classes: fluoroquinolone, rifamycin, oxazolidinone, nitroimidazole, diarylquinoline, benzothiazinone
1 Ongoing projects without a lead compound series can be viewed at
2 Combination regimens: first clinical trial (NC001) of a novel TB drug regimen testing the three drug combination of PA-824, moxifloxacin, and pyrazinamide was initiated November 2010 and completed in 2011 with promising results. The second clinical trial (NC002) of this regimen was launched in March 2012 and will test the efficacy of the regimen in drug-sensitive and multidrug-resistant patients. The third clinical trial (NC003) will evaluate PA-824, TMC-207, pyrazinamide and clofazimine in combinations and is scheduled to begin September 2012.
Updated: August 10, 2012

5. Key Recent Events
Rifapentine in LTBI – CDC recommendation December, 2011 Delaminid in MDR-TB – filed in EU Bedaquiline in MDR-TB – filed in US, EU

6. Key New Data ex CPTR
PanACEA high dose rifampin University of Liverpool / Malawi surrogate marker work

7. Key New Plans
“Universal” myco lab manual “Universal” EBA analytics manual Gatifloxacin Oflotub Phase 3 study results

8. Key New Preclinical Combo Data (Mouse Relapse Model)
6-wk to 2-mo regimens JZPC JZCM JZCU JZP JZC JZN JPaUZ (pending) NCE regimens JPaU: 4 mos JUC: 4 mos JPaUC: 4 mos JNU: 2 mos
J = bedaquiline Z = pyrazinamide P = rifapentine C = clofazimine M = moxifloxacin U = sutezolid Pa = PA-824 N = TBA354

9. Thank You !