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Page 1 CPTR Workshop, Oct. 2012 TB Drug Co-Development Roundtable Perspective from Bayer Dr. Martin Springsklee MD Head Global Medical Affairs Therapy.

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Presentation on theme: "Page 1 CPTR Workshop, Oct. 2012 TB Drug Co-Development Roundtable Perspective from Bayer Dr. Martin Springsklee MD Head Global Medical Affairs Therapy."— Presentation transcript:

1 Page 1 CPTR Workshop, Oct TB Drug Co-Development Roundtable Perspective from Bayer Dr. Martin Springsklee MD Head Global Medical Affairs Therapy Areas Anti-Infectives, Men’s Healthcare

2 Page 2 Workshop Arlington VA Oct. 4,2012 A “Historic” Opportunity to Improve Anti-TB Therapy: we’re getting closer and beyond st regimen: Streptomycin PAS Isoniazid 1963 Rifampin (RIF) discovered 1970 BMRC Trials add RIF 1974 BMRC Trials add RIF & PZA 2006 onward Trials substitute Moxifloxacin into regimen Pyrazinamide (PZA) discovered – but liver toxicity Rx lasts from months Rx shortened to 9 months Rx shortened to 6 months Rx target: 3-4 months Standard Therapy 2 months: rifampin, isoniazid, pyrazinamide, ethambutol + 4 months: rifampin, isoniazid Standard Regimen by 1960s based on 1952 drugs

3 Page 3 Workshop, Arlington VA, Oct 4,2012 The REMoxTB – Study: Rapid Evaluation of Moxifloxacin in TB Overall Goal:  Demonstrate that Moxifloxacin can shorten treatment duration to 3-4 months with optimized combination regime – uses non-inferiority hypothesis Treatment regimens: 3 arm study, randomized, double-blind, double-dummy, Standard regimen: 2 mo EHRZ /4 mo HR  Moxi to replace Ethambutol: 2 mo MHRZ / 2 mo HRM / 2 mo plac.  Moxi to replace Isoniazid: 2 mo EMRZ / 2 mo MR / 2 mo plac Current Status: Total no. of patients enrolled: 1931 First patient in: Q – Last patient in: Febr. 21, 2012 Last patient last treatment day: Aug 21, 2012 Expect topline results: Dec First regulatory submission planned for 2014

4 CPTR: 1 st Novel Combination Regimen Pa-M-Z Topline results Trial NC001 e-published in Lancet July 23 rd, 2012 *  First clinical study under the CPTR novel combinations development paradigm (“test more than one novel compound at a time”)  14d EBA study Phase IIa clinical proof-of-concept  Moxifloxacin plus PA824 plus Pyrazinamide  Study also evaluated Bedaquiline (TMC207) alone and in combinations with PA824 and with Pyrazinamide  Main results for Moxi containing arm:  EBA 0 – 2 days: log 10 /cfu/d  EBA days: log 10 /cfu/d  Active control arm HRZE:  EBA 0-2 days: log 10 /cfu/d  EBA days: log 10 /cfu/d  Pa-Z arm (without Moxi)  EBA 0 – 2 days: log 10 /cfu/d  EBA 0 – 14 days: log 10 /cfu/d * Diacon et al: The Lancet, published online July 23, Page 4 Workshop, Arlington VA, Oct 4,2012

5 Study NC001 Main Result: Log cfu Reduction Day 0 – Day 14 Page 5 Workshop, Arlington VA, Oct.4, 2012

6 Page 6 Workshop, Arlington VA, Oct. 4, 2012 CPTR: Outlook Pa-M-Z regimen  Results achieved in NC001 a successful „proof of concept“ for the CPTR regimen based development paradigm  Phase IIb study NC002 is underway (n=89 pts enrolled)  Main outcome variable: rate of change in CFU (SSCC)  Secondary variable: time to culture conversion  230 pts to be enrolled, 4 treatment groups, treatment duration 8 weeks  3 arms to be randomized (n=60 each, drug-sensitive TB)  PA mg + Moxi 400mg + Z 1500mg  PA mg + Moxi 400mg + Z 1500mg  Rifafour e-275 (HRZE) active control  1 arm open label (max. n =50 pts with MDR-TB):  PA mg + Moxi 400mg + Z 1500mg  Expect results in Q3/2013 Bayer is committed to further support the clinical development of the PaMZ combo via the CPTR coalition agreement – in addition to our continued committment to REMoxTB

7 Page 7 THANK YOU !


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