Consano Bio’s C-1101 receives FDA Fast Track Designation for chronic painful lumbosacral radiculopathy, or chronic sciatica, with Phase 1 study ongoing.
Written by: Creola Gonsalves, MS, Biotech
Reviewed by: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to C-1101, Consano Bio, Inc.’s lead investigational platelet-derived biologic for the treatment of chronic, painful lumbosacral radiculopathy (LSR), commonly known as chronic sciatica.
Headquartered in Burlington, Massachusetts, Consano Bio is developing C-1101 as a potentially disease-modifying, non-opioid treatment designed to address the underlying biology of nerve injury rather than simply manage pain. There are currently no FDA-approved pharmaceutical therapies indicated for LSR.
FDA Fast Track Designation for C-1101
The designation was granted based on the unmet medical need in LSR and the comprehensive nonclinical data package submitted in support of C-1101’s clinical potential. The FDA’s Fast Track program is designed to facilitate development and expedite review of therapies intended to treat serious conditions and address significant unmet medical needs.
Significant Burden of Chronic Sciatica
LSR represents a clinically significant subset of low back pain and is reported by Consano Bio as the leading cause of years lived with disability in the U.S. The condition also accounts for an estimated $135 billion in annual U.S. healthcare spending, more than any other condition, according to the company’s release.
LSR is also a major driver of opioid initiation and chronic opioid use in the U.S. For some patients, the condition can persist for years and progress to irreversible nerve damage and permanent disability. It is also associated with depression, anxiety, and elevated rates of suicidal ideation.
Phase 1 Study of C-1101
Consano Bio is advancing C-1101 in the multicenter, randomized, controlled, double-blind Phase 1 C-1101-101 study (NCT07264270). The trial is evaluating symptomatic patients with chronic painful LSR across three sequential dose-escalation cohorts, with each participant receiving a single epidural injection.
The study is enrolling in Australia and is extending into the United States following FDA clearance of Consano Bio’s Investigational New Drug (IND) application in July 2026.
C-1101 Designed to Address Nerve Injury
C-1101 is a novel, platelet-derived multi-protein biologic therapeutic and the first pharmaceutical therapy of its kind in development, according to Consano Bio.
The candidate is designed to treat LSR by modulating inflammation and stimulating and enhancing cellular repair at the site of injury. It contains consistent concentrations of cytokines, growth factors, and matrix proteins designed to help trigger the body’s natural healing response. Delivered through an epidural injection, C-1101 is intended to provide supraphysiologic concentrations of these proteins directly to the site of nerve injury.
Potential Non-Opioid Treatment Approach
Consano Bio is developing C-1101 as a potentially disease-modifying, non-opioid therapy for chronic LSR. The approach is intended to address the underlying biology of nerve injury rather than focus solely on pain management.
The investigational approach could provide an alternative therapeutic strategy in a condition associated with substantial opioid use, although C-1101’s safety and efficacy remain under clinical evaluation.
Executive Perspective
“Fast Track Designation underscores the significant unmet need in chronic sciatica, a serious and debilitating condition,” said Andrew Hall, Chief Executive Officer of Consano Bio. “C-1101 is designed to address the underlying biology of nerve injury rather than simply manage pain. We look forward to close collaboration with the FDA as we advance C-1101 through our ongoing Phase 1 study as a potential new treatment option for these patients.”
The Fast Track designation supports continued clinical development of C-1101 as Consano Bio evaluates its potential as a treatment for chronic painful LSR.
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About the Writer
Creola Gonsalves (Linkedin) is an M.S. Biotechnology postgraduate with a strong interest in clinical research, evidence interpretation, and healthcare writing, with a focus on translating life-science knowledge into meaningful real-world insights.
She is trained in Good Clinical Practice (GCP), clinical research principles, and critical interpretation of randomized clinical trials, with certifications from NIH and Stanford University.
Her research background in biotechnological applications and microbial research strengthens her ability to understand scientific evidence and develop clear, accurate, and research-driven healthcare content.