Otsuka Announces Worldwide Access Plan for Delamanid with Stop TB Partnership's Global Drug Facility - Seite 2

optimised patient management. Beyond delamanid, the initiative
includes the development of a first-ever paediatric formulation for
MDR-TB, diagnostic solutions, mHealth tools, and potential future
anti-TB drug candidates. Otsuka is also engaging in close to a dozen
third-party research collaborations looking at shorter, more
effective and more patient-friendly ways to fight MDR-TB. Included in
this, Otsuka is proud to work with Médecins Sans Frontières, Partners
in Health and Interactive Research & Development on the endTB project
which will evaluate new regimens for the treatment of MDR-TB and
reduce existing country-level barriers to the uptake of new TB drugs
while building a broader evidence-base for WHO recommendations.

About Delamanid

The efficacy of delamanid was studied in a large, randomized,
placebo-controlled phase 2 trial that included a 2-month treatment
period and a 1-month follow-up of 481 MDR-TB patients (Trial 204),
with 213 patients continuing to a 6-month open-label treatment trial
(Trial 208), and concluding with a 24-month follow-up study of 421
out of the originally randomized 481 patients (Trial 116). Adding 100
mg delamanid twice daily to a WHO-recommended optimized background
regimen (OBR) was associated with a statistically significant 53%
increase (p=0.008) in the percentage of patients achieving sputum
culture conversion (SCC) at 2 months (45.4%) compared to those with
placebo added (29.6%).[2],[3]

SCC is an indicator of when a patient is no longer infectious. The
more rapid clearance of TB bacilli is important since SCC at two
months is strongly correlated with improved patient outcomes.

Clinical trial results demonstrated that adverse events were
evenly distributed in the delamanid and placebo treatment groups with
the exception of QT prolongation. Electrocardiogram QT prolongation
was reported in 9.9% of patients receiving delamanid as 100 mg twice
daily compared to 3.8% of patients receiving placebo plus OBR. This
was not accompanied by any clinical symptoms such as syncope or
arrhythmias.[2]

A phase 3 trial of delamanid is fully enrolled, and involves six
months of treatment with delamanid plus OBR in patients with MDR-TB,
including those with co-existing HIV infection. The trial is taking
place in Estonia, Latvia, Lithuania, Moldova, Peru, the Philippines,
and South Africa with results expected in 2018. Additionally,
enrollment continues for a clinical program exploring the use of
delamanid in pediatric MDR-TB and is evaluating a dispersible
formulation for use with younger children and infants.

Delamanid has received regulatory approval in the European Union,
Japan and the Republic of Korea and registrations are underway in
China, Hong Kong, Indonesia, the Philippines and Turkey; delamanid is
not currently approved in the US. In 2014, the WHO published an
interim policy guidance on "The Use of Delamanid in the Treatment of
Multidrug-Resistant Tuberculosis"[4] and in 2015 delamanid was added
to the WHO's Essential Medicines List.

For more information, please visit: http://otsuka-onpg.com/

1. World Health Organization. Global Tuberculosis Report 2015.
Geneva, Switzerland. WHO/HTM/TB/2015.22

2. Gler MT, Skripconoka V, Sanchez-Garavito E, et al. Delamanid
for multidrug-resistant pulmonary tuberculosis. N Engl J Med.
2012;366:2151-60

3. SCC for groups dosed with delamanid were statistically higher
compared to placebo (45.4-29.6/29.6=0.5333) (p=0.008). Results from
secondary analysis of SCC based on solid media were consistent with
those of the primary analysis. The study found that by the end of
week five, 24% of subjects in the delamanid 100 mg BID group achieved
SCC compared with 13% of study subjects in the placebo group.

4. World Health Organization. The use of delamanid in the
treatment of multidrug-resistant tuberculosis - interim policy
guidance. 2014, Geneva, Switzerland. WHO/HTM/TB2014.23

ots Originaltext: Otsuka GmbH
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Marc Destito
Communications Director
Global TB Project
[e-mail]
[phone]