- Study to evaluate safety and efficacy of novel 3-drug combination versus existing 4-drug standard of care 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 the Bill & Melinda Gates Foundation to support the clinical trial of a treatment-shortening regimen in drug-sensitive tuberculosis.

The 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 bedaquiline (SIRTURO^®) for patients with drug-susceptible pulmonary tuberculosis.

Specifically, the grant will support a phase 2 clinical trial that investigates a novel regimen in shortening the treatment of drug-susceptible tuberculosis by comparing the proportion of study subjects receiving the combination therapy for a duration of 4 months versus the 6-month standard of care. Decreasing treatment duration is likely to impact the number of patients treated and improve overall treatment adherence.^*1

The trial will compare the 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.

The 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 the 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 the Gates Foundation-led Pan-TB Collaboration, a first-of-its-kind collaboration among philanthropic, non-profit and private sectors that aims to accelerate the development of an investigational drug regimen capable of treating all forms of TB.

DELTYBA is available in over 100 countries for the treatment of pulmonary, multidrug-resistant tuberculosis.

1. 1Sotgiu G, et al. Applicability of the shorter 'Bangladesh regimen' in high multidrug-resistant tuberculosis settings. Int. J Inf. Dis. 2017; 56: 190-193.