Global Alliance For Tb Drug Development Inc

TO ACCELERATE THE DISCOVERY & DEVELOPMENT OF NEW DRUGS TO FACILITATE THE CONTROL OF TUBERCULOSIS THROUGHOUT THE WORLD AND THE ACCESSIBILITY OF THESE DRUGS TO THE GLOBAL COMMUNITY.

RESEARCH AND DEVELOPMENT - TB ALLIANCE IS A NOT-FOR-PROFIT PRODUCT DEVELOPMENT PARTNERSHIP (PDP), UNIQUELY POSITIONED TO LEVERAGE A GLOBAL NETWORK OF PUBLIC AND PRIVATE PARTNERS TO MOST EFFICIENTLY ADVANCE TB DRUG DEVELOPMENT. A PDP BUILDS PARTNERSHIPS BETWEEN THE PUBLIC, PRIVATE, ACADEMIC, AND PHILANTHROPIC SECTORS TO DRIVE THE DEVELOPMENT OF NEW PRODUCTS FOR UNDERSERVED MARKETS. PDPS RETAIN DIRECT MANAGEMENT OVERSIGHT OF THEIR PROJECTS, THOUGH MUCH OF THE LABORATORY AND CLINICAL WORK IS DONE THOUGH EXTERNAL RESEARCH FACILITIES AND CONTRACTORS. WE COMBINE THE RESEARCH AND DEVELOPMENT EXPERTISE OF OUR STAFF WITH THE SKILLS AND RESOURCES OF OUR PARTNERS TO HARNESS THE MOST PROMISING SCIENCE WHEREVER IT MAY EXIST AROUND THE WORLD. THIS MODEL MINIMIZES COSTS, INCLUDING OVERHEAD AND INVESTMENTS IN INFRASTRUCTURE, WHILE OPTIMIZING SCIENTIFIC CAPABILITY TO SPEED NEW TB DRUG DEVELOPMENT. OUR BUSINESS MODEL AND DIVERSE PARTNERSHIPS ALLOW TB ALLIANCE TO LEVERAGE ADDITIONAL PARTNER SERVICES FOR EVERY DOLLAR INVESTED IN ITS PROGRAMS. SIMPLICITB - SIMPLICITB IS EVALUATING THE EFFICACY, SAFETY AND TOLERABILITY OF A NOVEL AND POTENTIALLY SHORTER DRUG REGIMEN (BPAMZ) FOR PATIENTS WITH DRUG-SENSITIVE (DS) AND DRUG-RESISTANT(MDR) PULMONARY TUBERCULOSIS (SPECIFICALLY MULTIDRUG-RESISTANT TB AND MONO-RESISTANCE TO ISONIAZID OR RIFAMPICIN). THE BPAMZ REGIMEN IS COMPRISED OF FOUR DIFFERENT ANTIMICROBIALS: BEDAQUILINE (B), PRETOMANID (PA), MOXIFLOXACIN (M)AND PYRAZINAMIDE (Z). THE NEW DRUG REGIMEN IS ADMINISTERED FOR FOUR MONTHS TO PATIENTS WITH DS-TB, AND FOR SIX MONTHS TO PATIENTS WITH MDR-TB OR MONO-RESISTANCE TO RIFAMPICIN OR ISONIAZID. RESULTS IN THE DS-TB ARM WILL BE COMPARED TO A CONTROL GROUP OF THE STANDARD SIX-MONTH DRUG REGIMEN FOR DS-TB (HRZE). ZENIX - THE PHASE 3 ZENIX CLINICAL TRIAL EVALUATED THE BPAL REGIMEN TO TREAT EXTENSIVELY DRUG RESISTANT TUBERCULOSIS (XDR-TB) AND THOSE WITH PRE-XDR-TB AND MULTI-DRUG RESIDENT TB (MDR-TB) WHOSE PRIOR TREATMENT HAS FAILED OR WHO HAVE NOT TOLERATED THEIR TREATMENT. IT SOUGHT TO OPTIMIZE LINEZOLID DOSING AS PART OF THE BPAL REGIMEN, EVALUATING BOTH THE LINEZOLID DOSE AND THE LINEZOLID DURATION. THE TOP-LINE RESULTS OF ZENIX WERE PRESENTED AT IAS 2021, SHOWING THAT THE EFFECTIVENESS OF THE BPAL REGIMEN COULD BE MAINTAINED WITH REDUCED DOSING OF LINEZOLID. THESE RESULTS HAVE BEEN ACCEPTED FOR PUBLICATION IN A PEER REVIEWED PAPER. THE RESULTS OF THE ZENIX TRIAL WERE INCORPORATED INTO A RAPID COMMUNICATION ON FORTHCOMING WORLD HEALTH ORGANIZATION GUIDELINES FOR THE TREATMENT OF DRUG-RESISTANT TB, ISSUED IN MAY 2022. THESE GUIDELINES WILL ENABLE A SIGNIFICANTLY BROADER PATIENT POPULATION TO BE TREATED WITH BPAL-BASED REGIMENS. LIFT-TB (LEVERAGING INNOVATION FOR FASTER TREATMENT OF TB) - THIS PROGRAM, LAUNCHED IN 2020, SEEKS TO INCREASE TREATMENT COMPLETION RATES FOR DRUG-RESISTANT TB THROUGH ADOPTION AND SCALE UP OF NEW REGIMENS, BEGINNING WITH BPAL. IT FOCUSES ON SEVEN HIGH-BURDEN SOUTHEAST AND CENTRAL ASIAN COUNTRIES THAT SHOULDER APPROXIMATELY 1 IN 5 OF THE GLOBAL TB CASES.

PUBLIC AFFAIRS AND POLICY - TB ALLIANCE MAINTAINS CRITICAL ALLIANCES WITH PUBLIC AND PRIVATE ORGANIZATIONS TO RAISE AWARENESS ABOUT TUBERCULOSIS ("TB") AND ADVOCATE FOR PUBLIC AND PRIVATE INVOLVEMENT IN RESEARCH FOR THE PUBLIC GOOD. SPECIFICALLY, TB ALLIANCE NEGOTIATES TERMS THAT SUPPORT THE DEVELOPMENT AND ACCESS OF NEW AFFORDABLE ANTI-TB DRUGS EQUITABLY FOR THOSE AREAS MOST IN NEED WHILE ENCOURAGING THE PRIVATE SECTOR ON THE DEVELOPMENT OF THESE MEDICINES. TB ALLIANCE CONTINUES TO PURSUE AN EXPLICIT COMMITMENT TO OUR "AAA MANDATE" - THAT ALL NEW PRODUCTS WILL BE ADOPTED, AVAILABLE AND AFFORDABLE TO THOSE WITH TB.

BUSINESS DEVELOPMENT - TB ALLIANCE NEGOTIATES, IMPLEMENTS AND MANAGES AGREEMENTS WITH PUBLIC AND PRIVATE ORGANIZATIONS WORLDWIDE AND DOES SO BY ADHERING TO SOUND BUSINESS PRACTICES WHILE ENSURING THE PUBLIC GOOD. SPECIFICALLY, TB ALLIANCE NEGOTIATES TERMS THAT SUPPORT THE DEVELOPMENT AND ACCESS OF NEW AFFORDABLE ANTI-TB DRUGS EQUITABLY TO THOSE AREAS MOST IN NEED WHILE ENCOURAGING THE PRIVATE SECTOR TO HELP DEVELOP NEW MEDICINES FOR TB INDICATIONS.