ACP-711 Shows Promising Safety Profile in Phase 1 Multiple-Ascending-Dose Study for Essential Tremor
Key Insights
Acadia Pharmaceuticals and Saniona (search) successfully completed Phase 1 multiple-ascending-dose study of ACP-711 (search) in healthy volunteers, demonstrating favorable safety and tolerability profile.
The study reported no serious adverse events, with most reported events being mild and no safety concerns observed in laboratory, cardiovascular, or neurological assessments.
Companies are pursuing regulatory approval to expand the study to include elderly volunteers and evaluate higher doses, with essential tremor (search) designated as the lead therapeutic indication.
Acadia Pharmaceuticals (Nasdaq: ACAD) and Saniona (search) (OMX: SANION) have announced positive initial results from their Phase 1 multiple-ascending-dose (MAD) study of ACP-711 (search), marking a significant step forward in their neuroscience drug development program.
The clinical trial (EUCT: 2024-514514-12-00) successfully evaluated ACP-711 (search), previously known as SAN711, across multiple dosing cohorts in healthy volunteers. The drug demonstrated a robust safety profile, with all participants completing the study and no serious adverse events reported. Investigators noted that the majority of adverse events were mild in nature, with no concerning findings in safety laboratory tests, cardiovascular monitoring, or neurological examinations.
Safety and Tolerability Profile
"The safety and tolerability data from this Phase 1 study provide a strong foundation for advancing ACP-711 (search)'s development program," said a spokesperson from the research team. The comprehensive safety assessment included multiple parameters:
- Complete laboratory safety panels
- Cardiovascular monitoring
- Neurological examinations
- Adverse event tracking and assessment
Strategic Development Plans
Based on these encouraging results, the development program has identified essential tremor (search) as the lead therapeutic indication. The companies have temporarily paused the study while seeking regulatory approval to:
- Expand the study population to include elderly healthy volunteers
- Evaluate higher repeated doses
- Optimize the therapeutic potential for the target indication
This strategic pause will allow for careful evaluation of the current data and preparation for the next phase of development, ensuring the most appropriate path forward for ACP-711 (search)'s clinical program.
About ACP-711
ACP-711 (search) represents a novel approach in neuroscience drug development, building on Acadia's established expertise in neurological disorders. The company has previously achieved significant milestones, including FDA approval for treatments in Parkinson's disease psychosis (search) and Rett syndrome (search).
The drug's development aligns with Acadia's broader mission of advancing breakthroughs in neuroscience to address unmet medical needs. The company's pipeline includes multiple programs targeting neuroscience and neuro-rare diseases, with ACP-711 (search) now positioned as a promising candidate for essential tremor (search) treatment.