Otsuka Pharmaceutical Co., Ltd., and its indirect subsidiary Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka), announce that the latter has been awarded a grant for up to US $10 million from the Bill & Melinda Gates Foundation to advance clinical development of Otsuka's investigational compound to treat tuberculosis (TB), OPC-167832, in combination with delamanid as the backbone of a pan-TB regimen in line with the World Health Organization's (WHO) Target Regimen Profiles (TRP).

The WHO TRPs are meant to assist drug developers in identifying important drug regimen features and aligning these with patient and programmatic needs at a country level. A pan-TB regimen could revolutionize TB treatment by offering an effective, 3-or-4 drug, fully oral regimen with an acceptable safety profile that could be administered to almost all patients with active TB regardless of their drug resistance profile.

In 2017, Otsuka completed a phase 1, single-ascending-dose study of OPC-167832. OPC-167832 is also being evaluated in pre-clinical studies using the hollow fiber system at the Baylor Scott & White Research Institute and in additional non-clinical studies in collaboration with the U.S. National Institutes of Health / National Institute of Allergy and Infectious Diseases.

The grant will allow Otsuka to further evaluate OPC-167832 as part of a novel trial design combining multiple-ascending-dose and early-bactericidal-activity studies for evaluation in drug-susceptible TB patients, scheduled to begin in the fourth quarter of 2018. It will also allow Otsuka to explore a combination of OPC-167832 plus delamanid for future evaluation of pan-TB regimens.

About OPC-167832

OPC-167832 is an anti-TB compound discovered and currently under investigation by Otsuka. It inhibits the enzyme DprE1, which is connected to synthesis involving mycobacterial cell walls. This is a different mechanism of action from other currently available anti-TB drugs.

About Delamanid

Delamanid inhibits the synthesis of mycolic acid, an essential component of mycobacterial cell walls. Regulatory approval has been received in the EU, Japan, South Korea, Hong Kong, the Philippines, Turkey and India where it is marketed as Deltyba^™.