OSAKA, Japan — May 28, 2026
Ono Pharmaceutical Co., Ltd. announced the presentation of new clinical data from its Phase 2 study evaluating ONO-2808, an investigational S1P5 receptor agonist, for the treatment of multiple system atrophy (MSA) at the 7th World Parkinson Congress (WPC) 2026 held in Phoenix, Arizona. The new findings demonstrated encouraging trends in slowing disease progression while maintaining a safety profile comparable to placebo, strengthening Ono Pharma’s position in the growing neurodegenerative disease treatment market. Based on the Phase 2 results, the company confirmed plans to advance ONO-2808 into a pivotal Phase 3 clinical study, marking an important development milestone for a disease area with extremely limited treatment options.
ONO-2808 Shows Promising Signals in Multiple System Atrophy
Multiple system atrophy is a rare and rapidly progressive neurodegenerative disorder characterized by impaired movement, autonomic dysfunction, and severe neurological decline. Currently, there are no approved disease-modifying therapies capable of slowing disease progression, leaving significant unmet medical need for patients and clinicians worldwide.
According to the Phase 2 randomized, double-blind, placebo-controlled study data presented at WPC 2026, ONO-2808 demonstrated a tendency toward suppressing disease progression compared with placebo based on key clinical and imaging assessments. Researchers observed encouraging trends in modified Unified Multiple System Atrophy Rating Scale (mUMSARS) scores as well as MRI-based brain volume measurements, suggesting the therapy may help slow neurological deterioration associated with the disease. These findings are particularly significant given the historically limited success of clinical programs targeting neurodegenerative disorders.
ONO-2808 targets the S1P5 receptor, a pathway believed to play an important role in neuroprotection and central nervous system function. By modulating this receptor, researchers hope the therapy may reduce neuroinflammation and protect nerve cells from progressive degeneration, potentially offering a novel therapeutic approach for patients with MSA.
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Safety Profile Supports Advancement Into Phase 3
The company reported that the incidence of treatment-emergent adverse events in the Phase 2 study was similar between the ONO-2808 and placebo groups, with no unexpected safety signals identified during the trial. Maintaining a favorable safety profile is considered particularly important in neurodegenerative diseases such as MSA, where patients often experience severe functional decline and limited therapeutic tolerance.
Ono Pharma stated that the encouraging combination of clinical activity, imaging data, and tolerability supported the decision to advance ONO-2808 into a pivotal Phase 3 development program. The upcoming late-stage study is expected to further evaluate the therapy’s potential to slow disease progression and improve long-term neurological outcomes in patients with MSA.
The data presentation at the World Parkinson Congress also highlights growing global scientific focus on rare neurological diseases and the increasing investment in therapies targeting underlying neurodegenerative mechanisms rather than symptom management alone.
Ono Pharma Expands Neurology Pipeline Strategy
Founded in Japan, Ono Pharmaceutical Co., Ltd. continues expanding its global research pipeline beyond oncology and immunology into neurology and rare diseases. The company has increasingly invested in advanced therapeutic platforms targeting difficult-to-treat conditions with high unmet medical need.
ONO-2808 represents part of Ono Pharma’s broader strategy to strengthen its neuroscience portfolio while expanding international clinical development capabilities. The company believes innovative approaches targeting neurodegenerative pathways could create future growth opportunities within the rapidly evolving central nervous system therapeutics market.
With the transition into Phase 3 development, ONO-2808 could become one of the most closely watched investigational therapies in the MSA treatment landscape, particularly as researchers continue searching for effective disease-modifying options capable of slowing progression in patients suffering from this devastating neurological disorder.
Source: Ono Pharma press release
