Astellas Pharma is launching a pioneering first-in-human clinical trial of ASP2246, a novel therapeutic agent designed to potentially improve motor function in chronic ischemic stroke patients through direct intracerebral delivery.
The phase 1/2 trial (NCT07318714) represents an innovative approach to addressing persistent motor dysfunction following stroke, targeting patients with supratentorial perforator area infarction 3-12 months post-event.
Trial Design and Key Elements
- First-in-human, multicenter study
- Enrollment: 84 participants (ages 18-80)
- Two-part design: dose escalation (Part 1) followed by randomized dose expansion (Part 2)
- Interventions include stereotactic brain surgery with intracerebral parenchymal infusion of ASP2246
- Comparator arm includes sham surgery
- Primary completion date: February 2030
Research Context
The trial addresses a critical unmet need in stroke rehabilitation. Current treatments for chronic stroke motor dysfunction remain limited, primarily focusing on rehabilitation and symptomatic management. ASP2246’s direct brain delivery mechanism represents a potentially transformative approach to neurological recovery.
The chronic stroke therapeutic landscape remains fragmented, with few advanced clinical-stage interventions. Key assets under development include NervGen Pharma’s NVG-291, CervoMed’s neflamapimod, Revalesio’s RNS60, and cell-based therapies such as CTX0E03 (PISCES trials). Several neuromodulation and device-based interventions (e.g., Vivistim Paired VNS™ System) are also in clinical use or late-stage development. However, the field is characterized by a paucity of large, late-phase trials and a high degree of translational risk.
Source: ClinicalTrials.gov