FDA Fast Tracks C-1101 for Chronic Sciatica

Consano Bio announced that the FDA granted Fast Track Designation to C-1101, its lead investigational, platelet-derived biologic for the treatment of chronic painful lumbosacral radiculopathy (LSR), commonly called chronic sciatica. The designation followed FDA clearance of the company’s investigational new drug (IND) application, according to the release.

C-1101 is a non-opioid, multi-protein biologic designed to modulate inflammation and stimulate cellular repair at the site of nerve injury. Consano said the product contains consistent concentrations of cytokines, growth factors, and matrix proteins and is delivered through an epidural injection. The company described chronic LSR as a condition involving damage or irritation of lower-back spinal nerve roots that can cause radiating leg pain, numbness, and weakness.

Consano said the designation was based on unmet need in LSR and a comprehensive nonclinical data package supporting C-1101’s clinical potential. The release stated that the Fast Track program is intended to facilitate development and expedite review of therapies for serious conditions with significant unmet medical needs.

The company is evaluating C-1101 in C-1101-101 (NCT07264270), a multicenter, randomized, controlled, double-blind phase 1 study in symptomatic patients with chronic painful LSR. The trial includes 3 sequential dose-escalation cohorts, with each participant receiving a single epidural injection. Enrollment is underway in Australia, and the study is extending into the US after the FDA cleared the IND application in July 2026.

Andrew Hall, chief executive officer of Consano Bio, said the designation reflects the unmet need in chronic sciatica and that the company expects to work closely with FDA as the phase 1 program advances. Consano said there are currently no FDA-approved pharmaceutical therapies indicated for LSR, and C-1101 remains under investigation in the phase 1 study described in the announcement.

Source:  Consano Bio. Consano Bio receives FDA Fast Track Designation for C-1101 in chronic, painful lumbosacral radiculopathy (LSR) or chronic sciatica. News release. Consano Bio; August 18, 2026. Accessed August 19, 2026.