ONO-2808 / Ono Pharmaceutical, Deciphera Pharmaceuticals - LARVOL DELTA

A Trial of ONO-2808 in Participants With the Parkinsonian Subtype of Multiple System Atrophy (MSA-P) (clinicaltrials.gov) - P3 | N=486 | Not yet recruiting | Sponsor: Ono Pharmaceutical Co., Ltd.

New P3 trial • CNS Disorders • Movement Disorders • Multiple System Atrophy • Parkinson's Disease

A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy (clinicaltrials.gov) - P2 | N=92 | Active, not recruiting | Sponsor: Ono Pharmaceutical Co., Ltd. | Trial completion date: Jan 2027 ➔ Oct 2027

Trial completion date • CNS Disorders • Movement Disorders • Multiple System Atrophy

Safety, tolerability, and preliminary efficacy of ONO-2808, a sphingosine-1-phosphate receptor 5 agonist, in multiple system atrophy (WPC 2026) - P2 | "ONO-2808 demonstrated acceptable safety. Safety and exploratory efficacy results at 24 weeks support continued clinical development for patients with MSA."

Clinical • Late-breaking abstract • CNS Disorders • Hepatology • Hypotension • Liver Failure • Movement Disorders • Multiple System Atrophy

Ono Pharma Announces Poster Presentation of New Clinical Data from Phase 2 Study of ONO-2808 (S1P5 Receptor Agonist) in Multiple System Atrophy at the 7th World Parkinson Congress (WPC) (Yahoo Finance) - "TEAEs incidence was similar to placebo (91%, n=21/23) and ONO-2808 (93%, n=64/69), with no unexpected safety signals. As exploratory efficacy endpoints, in the subgroup of parkinsonism-predominant type (MSA-P), the change from baseline (95% CI) of the mUMSARS score at 24 weeks was 3.90 (1.76 to 6.04) in the placebo group, compared to 1.39 (-0.85 to 3.64) and 1.16 (-1.1 to 3.41) in the medium-dose and high-dose groups, respectively. In brain volume assessment using MRI (magnetic resonance imaging), the ONO-2808 group showed a tendency toward a dose-dependent response to the suppression of brain atrophy progression. These data suggest that ONO-2808 has the potential for continued development, and Ono and its affiliate company Deciphera plan to initiate a pivotal Phase 3 study."

New P3 trial • P2 data • Multiple System Atrophy

A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy (clinicaltrials.gov) - P2 | N=92 | Active, not recruiting | Sponsor: Ono Pharmaceutical Co. Ltd | Trial completion date: Aug 2025 ➔ Jan 2027

Trial completion date • CNS Disorders • Movement Disorders • Multiple System Atrophy

Ono Announces Encouraging Efficacy Signals of ONO-2808, a S1P5 Receptor Agonist, in an interim analysis of Ongoing Phase 2 Clinical Trial in Patients with Multiple System Atrophy (Ono Pharmaceuticals Press Release) - "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."

P2 data • Multiple System Atrophy

A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy (clinicaltrials.gov) - P2 | N=92 | Active, not recruiting | Sponsor: Ono Pharmaceutical Co. Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Multiple System Atrophy

A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Ono Pharmaceutical Co. Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Multiple System Atrophy

A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Ono Pharmaceutical Co. Ltd

New P2 trial • CNS Disorders • Movement Disorders • Multiple System Atrophy

A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of ONO-2808-01 in Healthy Participants (clinicaltrials.gov) - P1; N=94; Completed; Sponsor: Ono Pharmaceutical Co. Ltd; Recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders