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Otsuka Awarded Grant for Phase 2 Trial Combining Novel Anti-Tuberculosis Compound OPC-167832 with Delamanid and Bedaquiline

PRINCETON, N.J.–()–Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka), a subsidiary of Otsuka Pharmaceutical Co., Ltd., announces that it has been awarded a grant for up to $17.8 million from the Bill & Melinda Gates Foundation. This will enable Otsuka to advance clinical trials of its investigational compound OPC-167832, in combination with its delamanid (DELTYBA® is the brand name where approved outside the U.S.) and Johnson & Johnson’s bedaquiline (SIRTURO® is the brand name), for patients with drug-susceptible pulmonary tuberculosis (DS-TB).

Employing a phase 2 design, the grant will support the investigation of a novel regimen in shortening the treatment of DS-TB 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

Specifically, the trial will compare the proportion of subjects with 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.

“Otsuka is honored to continue this vital collaboration with the Bill & Melinda Gates Foundation,” said Kabir Nath, president & CEO, Otsuka North America and senior managing director, Global Pharmaceutical Business. “Data gathered from this landmark trial will hopefully improve current management of TB and improve patient adherence by significantly shortening the duration of treatment. Otsuka remains steadfast in its mission to deliver innovative therapeutic options for TB patients worldwide.”

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 (DELTYBA) in a multiple ascending dose / early bactericidal activity (MAD/EBA) study that is ongoing in South Africa (ClinicalTrials.gov Identifier: NCT03678688). 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.

The phase 2 trial of OPC-167832, delamanid (DELTYBA) and bedaquiline (SIRTURO) is expected to begin in 2022 with results available in 2024.

About OPC-167832

OPC-167832 is an anti-TB compound discovered and currently under investigation by Otsuka. It inhibits the enzyme Decaprenylphosphoryl-β-D-ribose 2’-oxidase (DprE1), which is connected to synthesis involving mycobacterial cell walls. This is a different mechanism of action from other currently available anti-TB drugs. In vivo studies in mice suggest that OPC-167832 plus delamanid-containing regimens have the potential to shorten therapy and improve outcomes in drug-susceptible TB and multidrug-resistant TB (MDR-TB).2

About delamanid (DELTYBA)

Delamanid (DELTYBA) inhibits the synthesis of mycolic acid, an essential component of mycobacterial cell walls. It has been in use since 2014 for the treatment of pulmonary MDR-TB in adult patients where it has been difficult to construct a regimen due to tolerability or resistance issues. It has exhibited anti-TB efficacy and a favorable safety profile in multiple Otsuka-sponsored clinical trials, including two Phase 2 studies, an open-label Registry (Trials 204/208/116), and one Phase 3 study (Trial 213).3-5

DELTYBA is available in over 100 countries and regulatory approval has been received in the European Union, Japan, South Korea, Hong Kong, the Philippines, the Russian Federation, India, China, Indonesia, Kazakhstan, Mongolia, Peru, South Africa, Turkey, Turkmenistan and Ukraine. DELTYBA is not approved for use in the U.S.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 1,700 employees in the U.S. develop and commercialize medicines in the areas of mental health, nephrology, and cardiology, using cutting-edge technology to address unmet healthcare needs.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13.3 billion in 2020.

All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at www.otsuka.co.jp/en/.

References

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

2 Hariguchi N, et al. OPC-167832, a Novel Carbostyril Derivative with Potent Antituberculosis Activity as a DprE1 Inhibitor. Antimicrob Agents Chemother 64:e02020-19.

3 Gler M, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med 2012; 366: 2151-2160.

4 Skripconoka V, et al. Delamanid improves outcomes and reduces mortality in multidrug-resistant tuberculosis. Eur Respir J. 2013; 41:1393-400.

5 von Groote-Bidlingmaier F, et al. Efficacy and safety of delamanid in combination with an optimised background regimen for treatment of multidrug-resistant tuberculosis: a multicentre, randomised, double-blind, placebo-controlled, parallel group phase 3 trial. Lancet Respir Med 2019; 7(3):249-259.

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