Bial has discontinued development of its experimental therapy for a subgroup of Parkinson’s disease patients after a phase 2b study failed to meet both its primary and key secondary efficacy goals.
The Portugal-based company designed the trial to compare BIA 28-6156 with placebo in over 270 Parkinson’s patients carrying a pathogenic variant in the GBA1 gene. Participants assigned to the treatment groups received one of two doses of BIA 28-6156, a compound developed to activate the GCase enzyme in an effort to restore lipid metabolism and lysosomal function. Previous research has associated reduced GCase activity with disease progression in Parkinson’s patients.
Because of its mechanism of operation, BIA 28-6156 had been viewed as a potential disease-altering treatment. However, the phase 2b study failed to provide evidence that the therapy could improve patient outcomes. The trial’s primary endpoint assessed the time until patients experienced clinically noteworthy progression in motor-related aspects of daily living.
The study did not achieve its primary endpoint. Since BIA 28-6156 also failed to outperform placebo on important secondary measures, Bial decided to discontinue development of the candidate for the patient population studied. The company continues to conduct one additional study of BIA 28-6156, which is examining the therapy in individuals with varying levels of renal dysfunction.
Bial has not yet released detailed findings from the unsuccessful phase 2b trial, only stating that the study failed to demonstrate efficacy while indicating that BIA 28-6156 was generally well tolerated. According to the company, no unexpected safety issues emerged during the study. Bial stated that full results will be presented through scientific conferences and peer-reviewed articles.
The decision to halt development of BIA 28-6156 leaves a significant gap in Bial’s research and development pipeline. Aside from this program, the company is currently conducting only non-interventional research involving opicapone and a sublingual formulation of apomorphine, both targeting Parkinson’s disease. Bial secured European rights to the sublingual apomorphine therapy, Kynmobi, in 2021, while opicapone (marketed as Ongentys) received European approval in 2016.
This news comes roughly two months after Bial launched its ‘Dialogue With Parkinson’s’ campaign aimed at improving public understanding of Parkinson’s disease and helping people recognize its often subtle symptoms during the early stages.
Timed to coincide with World Parkinson’s Day 2026, Bial partnered with patient advocacy organization Parkinson’s Europe to highlight the importance of identifying symptoms early and to challenge the common assumption that Parkinson’s disease primarily affects older adults.
In an April 10 release, João Norte, Vice President of Global Marketing, Access and Patient Value at Bial, indicated that conversations with the Parkinson’s community revealed two persistent misconceptions surrounding the disease: the belief that Parkinson’s is exclusively linked to old age and a lack of awareness among individuals regarding their own symptoms.
Norte suggested that these misconceptions may contribute to delayed diagnoses, particularly among younger individuals, where symptoms can appear subtle or unexpected, potentially affecting the timely management of the disease, especially as younger people simply think this is not the time for them to be going through Parkinson’s.
Bial has announced the discontinuation of a Parkinson’s disease drug candidate after the program failed to achieve its objectives in a Phase 2 clinical study. The decision marks a significant setback for Bial, which has invested heavily in advancing innovative therapies for neurological disorders.
The move reflects the difficult reality of drug development, where promising early-stage research does not always translate into clinical success. While the outcome is disappointing, Bial emphasized that rigorous evaluation of trial data is essential to ensuring resources are directed toward the most promising scientific opportunities.
Phase 2 Results Fall Short of Expectations
According to available information, the Phase 2 study did not generate the efficacy results needed to justify continued investment in the asset. As a result, Bial chose to terminate further development rather than move the program into more expensive late-stage trials.
Impact on Bial’s Neurology Portfolio
Although the setback removes a potential future product from its pipeline, Bial continues to maintain a strong commitment to neuroscience research. The company has historically focused on neurological and rare diseases, and this strategic direction is expected to remain unchanged.
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