Consano Bio Wins FDA Nod for Chronic Sciatica Drug Trial
The U.S. Food and Drug Administration has cleared Consano Bio’s Investigational New Drug application for C-1101, a non-opioid therapy targeting chronic sciatica. This regulatory green light allows the Burlington-based biotech to expand its ongoing Phase 1 clinical trial into the United States, adding to current research efforts in Australia.
The clinical study, designated C-1101-101, utilizes a randomized, double-blinded approach to evaluate the safety and efficacy of the treatment. Researchers are enrolling patients across three sequential dose-escalation cohorts, with each participant receiving a single epidural injection. Andrew Hall, CEO of Consano Bio, noted that the clearance validates the company’s scientific and manufacturing standards, marking a pivotal shift in their transition toward U.S. clinical development.
Unlike traditional interventions that focus on temporary pain management or surgical procedures, C-1101 functions as a disease-modifying, platelet-derived multi-protein biologic. It aims to modulate inflammation and promote cellular repair at the site of spinal nerve root irritation. Given that no pharmaceutical treatments are currently FDA-approved for chronic lumbosacral radiculopathy, the company expects to begin dosing American patients within the coming months.
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