TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced that a phase III monotherapy study of satralizumab (development code: SA237), SAkuraStar Study (NCT02073279) for the treatment of neuromyelitis optica spectrum disorder (NMOSD), which currently has no approved treatments, has achieved the primary endpoint. The primary endpoint was time to first protocol-defined relapse in the double-blind period. A statistically significant reduction in the risk of relapse was confirmed in patients who received satralizumab, compared to those who received placebo. Furthermore, the safety profile of satralizumab was consistent with that seen in previous studies. Further details will be presented at a future medical meeting.
“We are pleased that satralizumab showed benefits also in a monotherapy setting following the previous results as add-on to baseline treatment in patients with NMOSD,” said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. “We will work diligently to prepare for regulatory filing so that we can offer a new treatment option to patients with NMOSD as soon as possible.”
SAkuraStar Study
Summary:
A phase III multicenter, randomized, double-blind,
placebo-controlled study to evaluate the efficacy and safety of
satralizumab administered to patients with NMOSD
Primary Endpoint
Time to first protocol-defined
relapse adjudicated by an independent review committee in the
double-blind period
Main Secondary Endpoints
Visual Analogue Scale (VAS) score
for pain
Functional Assessment of Chronic Illness Therapy (FACIT)
Fatigue score
Study Design:
- About 90 male and female patients aged from 18 to 74 years were randomized.
- Patients were randomized to either of the following two treatment groups in a 2:1 ratio. Satralizumab (120 mg) or placebo was subcutaneously administered at Week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals.
-
The double-blind period ended when the total number of
protocol-defined relapse had reached 44 or at 1.5 years after the
enrollment of the last patient, whichever occurred first.
After completion of the double-blind period, patients in both groups were able to continue treatment with satralizumab in an open-label extension period.
- Patients with neuromyelitis optica (NMO, as defined by the diagnostic criteria in 2006) and those with NMOSD (as defined by the diagnostic criteria in 2007) with anti-aquaporin-4 (AQP4) antibodies were enrolled.
[Reference]
Press release issued on October 15, 2018
Chugai
Presents Results from Phase III Study of Satralizumab in NMOSD at
ECTRIMS 2018
https://www.chugai-pharm.co.jp/english/news/detail/20181015120001_561.html
About Chugai
Chugai Pharmaceutical is one of Japan’s leading research-based
pharmaceutical companies with strengths in biotechnology products.
Chugai, based in Tokyo, specializes in prescription pharmaceuticals and
is listed on the 1st section of the Tokyo Stock Exchange. As an
important member of the Roche Group, Chugai is actively involved in R&D
activities in Japan and abroad. Specifically, Chugai is working to
develop innovative products which may satisfy the unmet medical needs,
mainly focusing on the oncology area.
In Japan, Chugai’s research
facilities in Gotemba and Kamakura are collaborating to develop new
pharmaceuticals and laboratories in Ukima are conducting research for
technology development for industrial production. Overseas, Chugai
Pharmabody Research based in Singapore is engaged in research
focusing on the generation of novel antibody drugs by utilizing Chugai’s
proprietary innovative antibody engineering technologies. Chugai
Pharma USA and Chugai
Pharma Europe are engaged in clinical development activities in the
United States and Europe.
The consolidated revenue in 2017 of
Chugai totalled 534.2 billion yen and the operating income was 103.2
billion yen (IFRS Core basis).
Additional information is available
on the internet at https://www.chugai-pharm.co.jp/english.
