Translational Basic Research Antitubercular onribosomal Peptides regon State Univ, IH Inhibitors for persistence targets IH, Texas A&M
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1 Kekkaku Vol. 84, o. 3: 133_140, 第 83 回総会教育講演. 要旨 Stop TB PartnershipWH itroimidazopyran PA-824, Moxifloxacin MFLX, Gatifloxacin GFLX, itroimidazo-oxazole PC-67683, Diarylquinoline TMC-207/ R207910, Diamine SQ-109, Pyrolle LL-3858Working Group on ew TB Drugs (WGD)/Stop TB Partnership Global Alliance for TB Drug Development (GATB/TB Alliance) キーワーズ/ 1. はじめに Bill and Melinda Gates BMGF Rockefeller CDCCenters for Disease Control and Prevention 2000 Global Alliance for TB Drug DevelopmentTB-Alliance 37 TB-Alliance Lilly MDR-TB Partnership TB-Alliance Lilly IHational Institute of Health 34 Biomarker Consortium 2. 新抗結核薬開発の目的 MXDR-TB TB-HIV 3. 開発中の新抗結核薬 Working Group on ew TB DrugsWGD/Stop TB Partnership/ WH Table _ _ 1 _ 24 ndoi@jata.or.jp Received 16 Dec. 2008
2 Translational Basic Research Antitubercular onribosomal Peptides regon State Univ, IH Inhibitors for persistence targets IH, Texas A&M Table 1Global TB Research and Development Projects information as of ctober 2007 (Working Group on ew TB Drugs, Stop TB Partnership/WH) ovel targets for treatment of latent TB Imperial College London, BMGF, Wellcome Trust Discovery b-sulfonylcarboxamides Johns Hopkins Univ, IH Dihydrolipoamide Acyltransferase Inhibitors Cornell Univ, IAID FtsZ Inhibitors Stony Brook, Colorado State Univ, SRI Lilly ot-for-profit Partnership for TB Early Phase Drug Discovery Eli Lilly & Co., IDRI, IAID Mycobacterial Sulfation Pathway Inhibitors Univ California Berkeley, IH Identification of compounds inhibiting pantothenate synthase (PanC) IH, IAID, UCLA Inhibitors of menaquinone biosynthesis Stony Brook, Colorado State Univ, IH, MSKCC Sterol Metabolism of M.tuberculosis Stony Brook, PHRI Identification and validation of targets for TB persisitence Seattle Biomedical Research Institute, BMGF Metabolic modeling of M.tuberculosis Univ Surry, Biotechnology and Biological Sciences Research Council Thymidylate Synthases as Drug Targets Univ Washington, IH Cell Wall Biosynthesis Inhibitors (1) Univ Birmingham, Strathclyde, Montpelier, Texas A&M, Wellcome Trust(2) Colorado State Univ, St Andrews Univ, Univ Tennessee Memphis Diphenyl ether based inhibitors of Fab1 (InhA) Stony Brook, IH, IAID, CSU, JMRC, Univ Wurzburg Indole derivatives Colorado State Univ, IH, IES Moscow Malate Synthase Inhibitors GlaxoSmithKline, Rockefeller Univ, Texas A&M, TB Alliance Mycobacterial Gyrase Inhibitors atural Products Exploration (1) ERC Centre, Univ Strathclyde, Univ Illinois Chicago (2) Georgia Institute of Technology, IH, Univ South Pacific (3) BITEC, California State Univ, ITR, IAID, TAACF, Univ Auckland itrofuranylamides IH, IAID, Univ Tennessee Health Science Centre, Colorado State Univ xazolidinones Pfizer Inc. M4TB Discovery Portfolio AstraZeneca, European Commission Peptide Deformylase Inhibitors Phenotypic Whole Cell Screening (1) Univ Illinois Chicago, TB Alliance(2) IH, IAID, TAACF(3) AstraZeneca Protease Inhibitors IDRI Riminophenazines Institute of Materia Medica, BTTTRI, TB Alliance Target-based screening, Lead ptimization AstraZeneca Preclinical Dipiperidine SQ-609 Sequella Inc. itroimidazole Backup Compound tsuka Synthase Inhibitor FAS20013 FASgen Inc. Clinical Capreomycin for Infalation MED, IAID, BMGF Gatifloxacin FLTUB Consortium: Lupin, IAID TBRU, Tuberculosis Research Centre, WH TDR Metronidazole for Latent Infection Imperial College London, BMGF, Wellcome Trust itrodihydro-imidazo-oxazole Derivative PC tsuka Pharmaceutical Co. Vitamin D Christian Medical College Vellore, Dalhousie University Proteasome Inhibitors Cornell University Sanofi-Aventis Portfolio Sanofi-Aventis Type-II ADH-menaquinone oxidoreductase inhibitors Univ Pennsylvania, Univ Illinois Chicago, IH Gyrase Inhibitor Pharma on-fluorinated Quinolone TaiGen Translocase I Inhibitors Sequella Inc., Sankyo Diamine SQ-109 Sequella Inc. Levofloxacin DMID/IAID/IH, TBRU Moxifloxacin (1) Bayer Pharmaceuticals, CDC TBTC, Johns Hopkins University, TB Alliance (2) DMID/IAID/IH, TBRU Pyrrole LL-3858 (Sudoterb) Lupin Limited Energy Metabolism InhA Inhibitors Multi-Functional Molecules Combre, TB Alliance Mycobacterial Siderophore Biosynthesis Inhibitors CDD at Univ Minnesota, IAID, IH itroimidazole Analogs TB Alliance, University of Auckland ovartis Portfolio ovartis Pleuromutilins Promazine Analogs Sallsbury University Quinolones KRICT/Yonsei University Small molecule inhibitors of validated targets Seattle Biochemical Research Institute, BMGF Compounds with in vivo activity against M. tuberculosis in animal models IH, IAID, Colorado State University xazolidinones Pharma Diarylquinoline TMC-207 Tibotec Pharmaceuticals Limited Linezolid* DMID/IAID/IH, TBRU itroimidazole PA-824 TB Alliance * For Linezolid Clinical Phase I study, various University partners are Univ. KwaZulu, Columbia University, Yale Univ., Univ. Texas, Univ. Cape Town, Univ. Boston. BTTTRI: Beijing Tuberculosis and Thoracic Tumor Research Institute CDC TBTC : Centers for Disease Control TB Trials Consortium CSIR : Council for Scientific and Industrial Research, South Africa DMID: Division of Microbiology and Infectious Diseases (US ational Institutes of Health) IMM: Institute of Materia Medica IAID TBRU: ational Institute of Allergy and Infectious Diseases, Tuberculosis Research Unit TRC: Tuberculosis Research Center, India WH TDR: WH Special Programme for Research and Training in Tropical Diseases (TDR) Rifapentine Sanofi-Aventis, TBTC (treatment), Johns-Hopkins University/IAID (prophylaxis)
3 Educational Lecture/ew TB Drugs and Chemotherapy /.Doi 135 Fig. 1Chemical structure of new Anti-TB drug candidates in clinical trial Phase IIII Fig Fig. 1Table 2 1 Moxifloxacin MFLX (Bayer) Fig. 1-1Gatifloxacin GFLX (WH) Fig MFLX Bayer TB-Alliance 8-methoxy MFLX isoniazidih MFLX 1) MFLX 28 WH gatifloxacingflx 2) MFLX 2 itroimidazopyran PA-824 (TB-Alliance) Fig PA PA-824 PA-824 cytochrome P450 isoenzymecyp3a4 TB-HIV HIV 3) PA-824 II 3 itroimidazo-oxazole PC (tsuka Pharm Co.) Fig nitroimidazole PA-824 PC profile
4 Table 2Strategic timetable plan towards launch (Working Group on ew TB Drugs, Stop TB Partnership / WH) Compound / Project Gatifloxacin: GFLX II II II/III III III III/DA Moxifloxacin: MFLX II II II/III III III III/DA Diarylquinoline: TMC-207 I I/II II II/III III III III DA itroimidazo-oxazole: PC I I/II II II/III III III III DA Pyrrole LL-3858 I I/II II II/III III III III DA itroimidazopyran: PA-824 I I I/II II II/III III III III DA Diamine SQ-109 I I I/II II II/III III III III DA Quinolones D D PC PC I I/II II II/III III III III itroimidazole Analogs D D PC PC PC/I I I/II II II/III III III Pleuromutilins D D PC PC PC/I I I/II II II/III III III Isocitrate Lyase Inhibitor D D D D PC PC I I/II II II/III III InhA Inhibitors D D D D/PC PC PC/I I I/II II II/III III *timetable based on information provided as of September D: Drug Discovery, PC: Pre-Clinical, IIII: Clinical Trial Phase IIII, DA: ew Drug Application Compound listed in gray zone indicate the projects in progress under the development of clinical testing stages I or III. Strategic Plan (Stop TB Partnership Working Group on ew TB Drugs), Prepared for the Global Plan to Stop TB: 2006 _ 2015Page 11: Table 2. Selected Drugs in Development: Timetable Towards Launch* PA-824 PC PA-824 PC PA-824 profile PC Cmax AUC 4) PC PA-824 P450 isoenzyme HIV PC-67683PA-824 PC MDR-TB 4 Diarylquinoline TMC-207 (Tibotec Pharm Limited) Fig TMC-207R ATP Tibotec MDR-TB TMC-207 Time Above MIC: TAM MACMycobacterium avium-intracellulare complex in vitro 5) TMC-207 P450 isoenzyme rifampicinrfptmc- 207 RFP IH MXDR-TB TMC-207 pyrazinamidepza 5 Pyrrole LL-3858 (Lupin Limited) Fig LL-3858 Lupin Diamine SQ-109Sequella Inc.Fig Diamine SQ-109 1, 2-ethylenediamine ethambutolebsq-109 EB SQ-109 EB EB EB In vitro SQ-109 Diarylquinoline TMC-207 SQ-109 6) 4. 非結核性抗酸菌症の治療薬 Diarylquinoline TMC-207 M.avium complexmactm in vitro EDP-420 EP : Bridged Bicyclic Ketolide; Enanta Pharm Inc.MAC 11) EDP-420 CAM clarithromycinmacrolide EDP-420 IIFig. 2
5 137 Educational Lecture / ew TB Drugs and Chemotherapy /. Doi H W H H H H H Me Me Clinical trial regimens in progress Symbol MFLX GFLX TMC-207 PC PA-824 SQ-109 LL-3858 M G J P S L H H H2 Candidate H H Me ew candidate drug for treatment of MAC infection Table Capuramycin (Sequella Inc. / Sankyo) EDP-420 (EP : Bridged Bicyclic Ketolide; Enanta Pharm Inc.) Fig. 2 H CH2 Trial regimen (RHZE: as Standard) RMZE / RHZM RHZG *BR J RZE RPZE RHZS H Clinical phase 5. 新抗結核薬 候補化合物の臨床試験と薬剤構成 現在進行中の新薬の臨床試験の各種薬剤構成を一覧に して Table 3 に示した TMC-207 を除き いずれの新薬も RFP との併用を前 提にしており PZA と EB はいずれの新規候補化合物と 併用しても競合する要素がないことから そのまま温存 H H H 3-2. CPZE-45 (The Lilly TB Drug Discovery Initiative) III II III II II II I I II R: RFP (rifampicin), H: IH (isoniazid), Z: PZA (pyrazinamide), E: EB (ethambutol) *BR: Background Regimens; PZA, KM (kanamycin), ETH (ethionamide), FLX (ofloxacin), CS (cycloserine) CH F H2 Me Me 1/2 H2 F 3-3. DC-159a (Daiichi-Sankyo Pharm) Fig. 3 ew Anti-TB drug candidates newly synthesized in Japan, in preclinical stage 換えられ 抗結核薬のラインアップから消えゆく宿命を 負っている 6. わが国で合成され開発途上にあるその他の 候補化合物 1 Capuramycin (Sequella Inc.) Fig されている MFLX PC PA-824 の臨床試験は Capuramycin は TL1 translocase 1 inhibitor と 略 称 さ いずれも IH H の位置にそれぞれの新薬を置き換えた れている 三共製薬により合成され 誘導体展開とスク 併用レジメンによる臨床導入が図られており 近い将来 リーニングアッセイを経て Seqella Inc. にライセンスア IH は結核化学療法レジメンから消失することを示唆し ウトされた候補化合物で 抗酸菌特異的な抗菌活性を示 ている 新 EB 誘導体 Diamine SQ-109 は EB に置き換え すが 経口吸収性がないことから噴霧吸入製剤として前 たレジメンを志向している なお Diarylquinoline TMC- 臨床試験の開発段階にある 7) IC 50 TL1 10 mcg/ml ; 207 の臨床試験 Phase II は MDR-TB 患者を対象として MIC 8 mcg/ml M. tuberculosis 相乗効果の高いPZA との併用を基本に TMC-207 プラス 2 CPZE-45 Caprazamycin B 誘導体 The Lilly TB backgroundレジメン PZA kanamycin KM ethionamide Drug Discovery Initiative Fig TH ofloxacin FLX terizidone/cycloserine CS を適 宜組み合わせた構成で実施されている Caprazamycin は放線菌の培養液から抽出分離された核 酸系抗生物質である Caprazamycin 類は結核菌に対する 結核とエイズという 2 種類の異なる化学療法の同時治 特異的な狭域の抗菌活性スペクトルを示し 上記の 療 TB-HIV では 相互に拮抗する主要薬剤 RFP と蛋 Capuramycin 同様に結核菌の細胞壁ペプチドグリカン生 白阻害剤等 を含む化学療法上の問題点が 現時点では 合成における translocase 1 の阻害剤として作用すると考 解消できないままに残されている しかし いずれ次世 えられる 8) 初期の化合物 caprazamycin B CPZ-B から 代の標準併用治療レジメンでは RFP も他の新薬に置き 誘導体展開し スクリーニングで得られた CPZE-45 は
6 CPZ-B MIC 3.13 mcg/ml M.tuberculosisCPZ-BCPZE-45 M(X)DR-TB CPZE-45 RFP CPZE-45 RFP 1/41/5 RFP Caprazamycin-B CPZE-45 Liposidemycin 3 DC-159aew Generation of Respiratory Quinolone ; Daiichi-Sankyo Pharm Co.Fig DC-159a QR-MXDR-TB MIC DC-159a MFLX GFLXIHRFP EBAearly bactericidal activity DC-159a IHRFP MFLX DC-159a Lung/Serum: AUC ratio:> 4 M.avium-intracellulare complexmac 9) 10) DC-159a 2007 Gram 7. M(X)DR-TB,TB-HIV に対する治療の可能性 ; 結核化学療法の今後. DDS Drug Delivery SystemDDS Aerosolized Drug in DDS PLGAlipid-microspherenanosphereliposome / HIV inhalation DDS targeting DDS controlled release long-lasting activity DDS TB-HIV cytochrome P450isoenzymeCYP3A4 MXDR-TB TB-HIV HIV TB-HIV viral load relapse case TB-HIV persistencylatency low responsibility high tolerability HIV /21 8. 結び 78
7 Educational Lecture/ew TB Drugs and Chemotherapy /.Doi 139 MXDR-TB 12) 13) 57 Stop TB Partnership TB-Alliance MXDR-TB TB/ HIV 14) 文献 1 Pletz MW, De Roux A, Roth A, et al.: Early bactericidal activity of moxifloxacin in treatment of pulmonary tuberculosis : a prospective, randomized study. Antimicrob Agents Chemother ; 48 : 780 _ Cynamon MH, Sklaney M : Gatifloxacin and ethionamide as the foundation for therapy of tuberculosis. Antimicrob Agents Chemother ; 47 : 2442 _ Stover CK, Warrener P, VanDevanter DR, et al.: A smallmolecule nitroimidazopyran drug candidate for the treatment of tuberculosis. ature ; 405 : 962 _ Matsumoto M, Hashizume H, Tomoshige T, et al.: PC , a nitro-dihydro-imidazo-oxazole derivatives with promising action against tuberculosis in vitro and in mice. PLoS Medicine ; 3 : 11 : 0001 _ Andries K, Verhasselt P, Guillemont J, et al.: A diarylquinoline drug active on the ATP synthase of Mycobacterium tuberculosis. Science ; 307 : 223 _ ikonenko BV, Protopopova M, Samala R, et al. : Drug Therapy of Experimental Tuberculosis (TB) : Improved utcome by Combining SQ109, a ew Diamine Antibiotic, with Existing TB Drugs. Antimicrob Agents Chemother ; 51 : 1563 _ Koga T, Fukuoka T, Doi, et al.: Activity of capuramycin analogues against Mycobacterium tuberculosis, Mycobacte- rium avium and Mycobacterium intracellulare in vitro and in vivo. J Antimicrob Chemother ; 54 : 755 _ Igarashi M, akagawa, Doi, et al.: Caprazamycin B, novel anti-tb antibiotics, from Streptomyces sp. J Antibiot ; 56 : 580 _ Doi, Disratthakit A: In vitro Anti-Mycobacterial Activity of A ew Generation of Respiratory Quinolone, DC-159a. 46th ICAAC, Poster o. F-0491, Doi, Disratthakit A, giso S, et al.: In vivo Efficacy of DC-159a, a ew Generation of Respiratory Quinolone against Experimental Murine Tuberculosis due to Multi- Drug-Resistant Mycobacterium tuberculosis. 46th ICAAC, Poster o. F-0492, Bermudez LE, Motamedi, Chee C, et al.: EDP-420, a bicyclolide (bridged bicyclic macrolide), is active against Mycobacterium avium. Antimicrob Agents Chemother ; 51 : 1666 _ CDC : Emergence of Mycobacterium tuberculosis with extensive resistance to second-line drugs worldwide, 2000 _ MMWR Weekly, March 24, 2006 ; 55 : 301 _ Goodhi R, Moli A, Sturn AW, et al. : Extensive drug- resistant tuberculosis as a cause of death in patients coinfected with tuberculosis and HIV in a rural area of South Africa. Lancet ; 368 : 1575 _ TB-Alliance: Handbook of Anti-Tuberculosis Agents. Tuber- culosis (ELSEVIER) ; 88 : 2 : 85 _ 169.
8 The 83rd Annual Meeting Educational Lecture EW HRIZS F EXT GEERATI CHEMTHERAPY FR MYCBACTERISIS orio DI Abstract : Stop TB Partnership (WH) reported Global TB Research and Development Projectson the basis of the annual survey (ctober 2007) : Basic Research : 9 projects, Drug Discovery : 32 projects, Preclinical: 8 projects, Clinical Testing : 13 projects are in proceeding. Among them, promising 7 of the new Anti-TB drug candidates: itroimidazopyran PA-824, Moxifloxacin MFLX, Gatifloxacin GFLX, Diarylquinoline TMC-207/R207910, itroimidazo-oxazole PC , Pyrrole LL-3858 and Diamine SQ-109 are in progress in clinical trial Phase I _ III. In 2006, Working Group on ew TB Drugs (WGD)/Stop TB Partnership and Global Alliance for TB Drug Development (GATB/TB Alliance) target: by 2010, 1 _ 2 new drugs will be registered for TB; by 2015, 7 new drugs registered for TB indication, and treatment will be shortened regimens of 3 _ 4 months with affordable and highly effective drugs. Key words : Anti-TB drug, Chemotherapy, M(X)DR-TB, TB/HIV co-infection case Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association Correspondence to: orio Doi, Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, 3 _ 1 _ 24, Matsuyama, Kiyose-shi, Tokyo 204 _ 8533 Japan. ( ndoi@jata.or.jp)
Summary
世界における新しい抗結核薬開発の現状 土井教生 ( 財 ) 結核予防会結核研究所研究部 / 主任研究員 はじめに ( 2007. 1. 15 現在 ) 新抗結核薬開発の分野では目下 米国 Bill and Melinda Gates Foundation と Rockefeller 財団その他の資金援助と CDC(Centers for Disease Control and Prevention)
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3 1 24 ndoi@jata.or.jp 30 1 phase nitroimidazopyran PA-824 phase rifalazil KRM-1648 long-lasting 8-methoxy-fluoroquinolone gatifloxacin GFLX moxifloxacin MXFX ketolide ABT-773 HMR-3647 MAC MAC Caprazamycin-B
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