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pp-077

Injection

Dossier type
CTD
Dossier status
Under development
Country of origin
Japan
GMP approvals
Japan
Comments
Indication: Acute cervical spinal cord injury, targeting neuroprotection, axonal regeneration, and functional motor recovery. Clinical stage: Phase I/II placebo-controlled double-blind comparative study completed with proof of concept; Phase III multicenter, non-randomized confirmatory study using intrathecal KP-100IT completed; additional clinical studies in Japan planned. Mechanism / Target: action on c-MET receptors to promote neuronal survival, inhibit apoptosis, enhance angiogenesis, and support axonal repair and regeneration in injured spinal cord tissue. Route / form: Intrathecal injection into the cerebrospinal fluid, administered repeatedly over the early post-injury period (as in clinical trials). Differentiation: First-in-class regenerative biologic targeting multiple repair pathways in acute spinal cord injury; demonstrated safety and clinical proof of concept in early trials; holds orphan drug designation in Japan for this indication..
Manufacturer #38606

A clinical-stage biopharmaceutical firm pioneering regenerative medicines based on a human growth factor protein. It develops therapies for intractable and rare diseases — including spinal-cord injury, organ damage, and tissue scarring — with global development and commercialization ambitions.

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