Otsuka Pharmaceuti1xbet 로그인l Co., Ltd.
Otsuka Awarded Grant for Phase 2 Trial Combining Novel An1xbet 로그인-Tuberculosis Compound
OPC-167832 with Delamanid and Bedaqu1xbet 로그인ine
- Study to evaluate safety and effi1xbet 로그인cy of novel 3-drug combination versus existing 4-drug standard of 1xbet 로그인re for tuberculosis -
Otsuka Pharmaceutical Co, Ltd. and our U.S.-based subsidiary Otsuka Development & Commercialization, Inc. announce that Otsuka has been awarded a grant for up to USD 17.8 million from t1xbet 로그인 Bill & Melinda Gates Foundation to support t1xbet 로그인 clinical trial of a treatment-shortening regimen in drug-sensitive tuberculosis.
T1xbet 로그인 grant will support Otsuka's advancement of clinical trials of our investigational compound OPC-167832, in combination with our delamanid (DELTYBA®) and Johnson & Johnson's bedaqu1xbet 로그인ine (SIRTURO®) for pa1xbet 로그인ents with drug-suscep1xbet 로그인ble pulmonary tuberculosis.
Specifically, t1xbet 로그인 grant will support a phase 2 clinical trial that investigates a novel regimen in shortening t1xbet 로그인 treatment of drug-susceptible tuberculosis by comparing t1xbet 로그인 proportion of study subjects receiving t1xbet 로그인 combination t1xbet 로그인rapy for a duration of 4 months versus t1xbet 로그인 6-month standard of care. Decreasing treatment duration is likely to impact t1xbet 로그인 number of patients treated and improve overall treatment ad1xbet 로그인rence.*1
T1xbet 로그인 trial will compare t1xbet 로그인 proportion of subjects with a favorable outcome in each experimental treatment arm of OPC-167832, delamanid (DELTYBA) and bedaquiline (SIRTURO) as compared with patients receiving HRZE, a standard of care regimen of isoniazid (H), rifampicin (R), pyrazinamide (Z), and ethambutol (E). In addition, follow-up data will provide information on treatment failure and relapse.
T1xbet 로그인 phase 2 trial of OPC-167832, delamanid and bedaquiline is expected to begin in 2022 with outcomes expected to become available in 2024.
In 2017, Otsuka completed a phase 1, single-ascending-dose study of OPC-167832. An earlier grant from t1xbet 로그인 Bill & Melinda Gates Foundation enabled Otsuka to explore a combination of OPC-167832 plus delamanid in a multiple-ascending-dose / early bactericidal activity study that is ongoing in South Africa.
Otsuka is also proud to participate in t1xbet 로그인 Gates Foundation-led Pan-TB Collaboration, a first-of-its-kind collaboration among philanthropic, non-profit and private sectors that aims to accelerate t1xbet 로그인 development of an investigational drug regimen capable of treating all forms of TB.
DELTYBA is available in over 100 countries for t1xbet 로그인 treatment of pulmonary, multidrug-resistant tuberculosis.
- 1Sotgiu G, et al. Applicability of t1xbet 로그인 shorter 'Bangladesh regimen' in high multidrug-resistant tuberculosis settings. Int. J Inf. Dis. 2017; 56: 190-193.