GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT INC

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 THROUGH 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 WAS A PHASE III CLINICAL TRIAL EVALUATING THE EFFICACY, SAFETY, AND TOLERABILITY OF A NOVEL AND POTENTIALLY SHORTER DRUG REGIMEN (BPAMZ) FOR PATIENTS WITH DRUG-SENSITIVE (DS) AND DRUG-RESISTANT (DR) 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 DRUG REGIMEN WAS 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. THE RESULTS OF THIS CLINICAL TRIAL WERE PUBLISHED IN LANCET INFECTIOUS DISEASES. SUTEZOLID - SUTEZOLID IS A PROMISING CLINICAL-STAGE TB DRUG CANDIDATE FROM THE OXAZOLIDINONE CLASS. TB ALLIANCE HAS IMPLEMENTED AN OPEN DEVELOPMENT APPROACH TO ADVANCE THE PHASE 2 TB DRUG CANDIDATE, SUTEZOLID, WHICH COULD BE A COMPONENT OF A NEXT-GENERATION TB REGIMEN. TB ALLIANCE HAS MADE SUTEZOLID AVAILABLE FOR STUDY BY ALL RESEARCHERS WHO COMMIT TO MAKING THEIR RESULTS AVAILABLE TO THE BROADER TB RESEARCH COMMUNITY. THIS NOVEL APPROACH HAS CONTRIBUTED TO THREE CLINICAL TRIALS THAT BEGAN IN 2023. NC-009 - NC-009 IS A PAN-PHASE 2 CLINICAL TRIAL INCORPORATING ELEMENTS OF PHASE 2A, B, AND C TO EVALUATE THE SAFETY AND EFFICACY OF A COMBINATION OF A NEW EXPERIMENTAL COMPOUND, TBAJ-876, WITH PRETOMANID AND LINEZOLID, COMPONENTS OF TB ALLIANCE'S BPAL REGIMEN. THIS REGIMEN HAS THE POTENTIAL TO SHORTEN AND IMPROVE TREATMENT FOR BOTH DRUG-SENSITIVE AND DRUG-RESISTANT FORMS OF TB. RESULTS FROM PRECLINICAL AND PHASE 1 STUDIES WERE PRESENTED AT THE 2023 UNION CONFERENCE ON LUNG HEALTH AND SHOWED THAT THE NEW COMPOUND, TBAJ-876, WHEN COMPARED WITH BEDAQUILINE (A TB MEDICINE IN THE SAME DRUG CLASS), ELIMINATED TB BACTERIA FASTER AND HAD A POTENTIALLY SAFER PROFILE. NC-009 WILL TEST DIFFERENT DOSES OF TBAJ-876 IN COMBINATION WITH PRETOMANID AND LINEZOLID AGAINST THE CURRENT STANDARD OF CARE FOR DRUG-SENSITIVE TB - ISONIAZID, RIFAMPICIN, PYRAZINAMIDE, AND ETHEMBUTOL (HRZE). ANOTHER ARM OF THE TRIAL WILL ALSO TEST PRETOMANID AND LINEZOLID IN COMBINATION WITH BEDAQUILINE (BPAL), A REGIMEN NOW RECOMMENDED BY THE WORLD HEALTH ORGANIZATION TO TREAT SOME FORMS OF DR-TB, AGAINST DRUG-SENSISTIVE TB. THE STUDY AIMS TO ENROLL 300 PARTICIPANTS WITH DRUG-SENSITIVE TB AT 21 CLINICAL TRIAL SITES IN FIVE COUNTRIES: GEORGIA, PHILIPPINES, SOUTH AFRICA, TANZANIA, AND UGANDA. LIFT-TB (LEVERAGING INNOVATION FOR FASTER TREATMENT OF TB) - THIS ACCESS 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. AS OF 2023, MORE THAN 70 COUNTRIES HAVE PROCURED THE SIX-MONTH, ALL-ORAL BPAL REGIMEN TO TREAT MORE THAN 40,000 PEOPLE WITH DRUG-RESISTANT TB. FAST TRACK THE CURE - IN SUPPER OF THE WORLD HEALTH ORGANIZATION'S CALL TO ACTION TO ACCELERATE ACCESS TO SHORTER DR-TB CURES FOR ALL, THE FAST TRACK THE CURE MOVEMENT BRINGS COMMUNITIES AROUND THE WORLD TOGETHER TO RAISE AWARENESS AND FACILITATE ACCESS TO NEW DR-TB TREATMENTS, WHILE RAMPING UP ADVOCACY TO CONVINCE WORLD LEADERS THAT SIX-MONTH DR-TB CURES MUST BE WIDELY ADOPTED AND AVAILABLE TO ALL WHO NEED THEM. FAST TRACK THE CURE IS ALSO COLLABORATING CLOSELY WITH STOP TB TO ENSURE STRATEGIC ALIGNMENT AND PARTNERSHIP AND WITH THE CHALLENGE FACILITY FOR CIVIL SOCIETY MOVEMENT, BY ALIGNING WITH THEIR COMMUNITY ENGAGEMENT, CAPACITY BUILDING, AND DEMAND CREATION PILLARS AND FOCUS. SLASH-TB - TB ALLIANCE AND THE SWISS TROPICAL AND PUBLIC HEALTH INSTITUTE HAVE DEVELOPED SLASH-TB (SAVINGS FROM LEVERAGING & ADOPTING SHORTER & HIGHLY EFFECTIVE TB TREATMENTS), A MODEL TO ESTIMATE COST SAVINGS FOR HEALTH SERVICE SYSTEMS, PATIENTS, FAMILIES, AND/OR CAREGIVERS WHEN USING THE BPAL/M REGIMENS AS COMPARED TO STANDARD DRUG-RESISTANT TB TREATMENTS.

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.