Consano Bio has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for C-1101, an investigational treatment being developed for chronic, painful lumbosacral radiculopathy (LSR), commonly known as chronic sciatica.
C-1101 is Consano Bio’s lead clinical-stage platelet-derived biologic. The company is developing the treatment to address the underlying nerve injury linked to chronic sciatica rather than simply managing pain.
There are currently no FDA-approved pharmaceutical treatments specifically indicated for LSR, creating a significant unmet need for patients living with the condition.
LSR is a common form of lower back pain caused by irritation or damage to nerves in the lower spine. The condition can cause persistent pain and, in some patients, may lead to nerve damage and long-term disability.
Chronic sciatica can also have a major impact on patients’ quality of life and has been linked to increased use of opioids, as well as higher rates of depression, anxiety and suicidal thoughts.
“Fast Track Designation underscores the significant unmet need in chronic sciatica,” said Andrew Hall, CEO of Consano Bio. He said C-1101 is designed to target the biology behind nerve injury and that the company plans to work closely with the FDA as development continues.
The FDA granted the designation based on the unmet need associated with chronic LSR and nonclinical data submitted by Consano Bio supporting the potential of C-1101.
The Fast Track program is intended to help speed the development and review of medicines for serious conditions where existing treatment options are limited. The designation can provide companies with opportunities for closer communication with the FDA during development and regulatory review.
Consano Bio is currently testing C-1101 in a Phase 1 clinical trial known as C-1101-101. The randomized, controlled and double-blind study is evaluating the treatment in patients with symptomatic chronic painful LSR.
The trial includes three dose-escalation groups, with each participant receiving a single epidural injection. The study is being conducted across multiple centers and initially began enrolling patients in Australia.
Consano Bio is now expanding the study into the United States after receiving FDA clearance for its Investigational New Drug application in July 2026.
The company hopes the ongoing study will provide important safety and early clinical data as it advances C-1101 as a potential treatment for people living with chronic sciatica.
If successful, C-1101 could offer a new approach for a condition that currently has limited pharmaceutical treatment options and can cause long-lasting pain and disability.