Tuberculosis: The Power of Innovation and Partnership Mel - PowerPoint PPT Presentation

Tuberculosis: The Power of Innovation and Partnership Mel Spigelman, M.D. Global Alliance for TB Drug Development Washington, DC - March 19, 2012

TB Alliance Vision Current Treatment New Treatments in Our Vision Development 6-30 2-4 7-10 Months Months Days Success will require novel drug combinations CURE All: A briefing on promising new TB drugs research 2

TB Drug/Regimen Discovery and Development Process Discovery Single Compound Phase II  Phase III Compound 1 Preclinical Development  Phase I  EBA Compound 2 Regimen A Drug Compound 3 Candidate Regimen B Pool Compound 4 Compound 5 Regimen C Regimen Identification Identification of New Drug Selection of Potential New Candidates Regimens CURE All: A briefing on promising new TB drugs research 3

Launch of the Critical Path to TB Drug Regimens (CPTR) CURE All: A briefing on promising new TB drugs research 4

CPTR Initiative Tackling Challenges to TB Drug Development Critical Path to TB Drug Regimens CPTR Regulatory CPTR Drugs CPTR Research Science Coalition Resources Consortium Led by the TB Led by the Bill and Led by the Critical Alliance Melinda Gates Path Institute Foundation Focus  Data standards &  Drug combination  Clinical trials integration testing and infrastructure  Biomarkers and development  Resource mobilization endpoints as disease  Regulatory response assays harmonization  Animal models  Access and appropriate  Pharmacology use  Disease progression models CURE All: A briefing on promising new TB drugs research 5

NC-002 – A New Pathway to Treating TB • Oral, once daily regimen consisting of PA-824 + moxifloxacin + pyrazinamide (PaMZ) • 8-week trial at 8 sites The Promise of • Promising attributes of NC-002 NC-002 – First-ever testing of a regimen in both DS- and MDR-TB patients at the same time – Potential for major impact • shorten MDR-TB therapy by 80% • decrease cost of treating MDR-TB by 90% • compatible with simultaneous use of anti-retrovirals (ARVs) • dramatically ease delivery and distribution logistics • Pace and scope of new TB regimen trials to accelerate in 2012-13 CURE All: A briefing on promising new TB drugs research 6

A world without TB…