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Drug Development Coalition

Drug Development Coalition. CPTR Workshop October 3 , 2012. CPTR Organization. Clinical Trials I nfrastructure WG. Integrated Sciences T eam Data Standards & Integration WG Biomarkers & Clinical Endpoints WG Preclinical & Clinical Sciences WG

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Drug Development Coalition

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  1. Drug Development Coalition CPTR Workshop October 3, 2012

  2. CPTR Organization • Clinical Trials Infrastructure WG • Integrated Sciences Team • Data Standards& Integration • WG • Biomarkers & Clinical Endpoints WG • Preclinical & Clinical Sciences WG • Clinical Disease Progression Modeling WG • Health Authorities Submission WG Regulatory Science Consortium Research Resources Group • Global Regulatory Pathways WG • Stakeholder & Community Engagement WG • Access & Appropriate Use WG Drug Development Coalition [Enter Presentation Title in Insert Tab > Header & Footer

  3. Drug Development Coalition Signatories • AstraZeneca • Bayer • JNJ • Sanofi • TB Alliance • WHO

  4. Global TB Drug Pipeline Discovery1 Preclinical Development Clinical Development Diarylquinoline InhA Inhibitors LeuRSInhibitors Mycobacterial Gyrase Inhibitors Pyrazinamide Analogs Riminophenazines Ruthenium (II) complexes Spectinamides Translocase-1 Inhibitors BTZ043 TBA-354 CPZEN-45 DC-159a Q201 SQ609 SQ641 AZD5847 Bedaquiline (TMC-207) Linezolid Novel Regimens2 PA-824 Rifapentine SQ-109 Sutezolid(PNU-100480) 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 http://www.newtbdrugs.org/pipeline-discovery.php. 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. www.newtbdrugs.org 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 • GatifloxacinOflotubPhase 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 !

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