Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono") announced that efficacy signals for ONO-2808, a S1P5 receptor agonist, were observed in the interim analysis of the Phase 2 clinical trial (ONO-2808-03 study) which assessed the safety and efficacy of ONO-2808 compared to placebo in patients with multiple system atrophy (MSA). In the exploratory interim analysis of this study, it was observed that the progression of MSA tended to be slower in the ONO-2808 group in terms of the clinical outcome endpoint, Unified Multiple System Atrophy Rating Scale (UMSARS). All doses were well tolerated with a manageable safety profile. Ono will present the results at an upcoming medical and scientific conference.

ONO-2808-03 Study
The ONO-2808-03 study is a multicenter, randomized Phase 2 clinical trial in early MSA patients within 5 years of symptom onset in Japan and the US. In the 2-part study, the core part, participants received ONO-2808 (3 doses) or placebo orally once daily for 24 weeks. The objective of the core part is to assess the safety, tolerability, pharmacokinetics and potential efficacy of ONO-2808 in comparison with placebo. After the completion of the core part, ONO-2808 will be administered for up to 80 weeks in the extension part to assess the safety, tolerability and potential efficacy of long-term treatment with ONO-2808.