Consano Bio Receives FDA IND Clearance for C-1101, a First-in-Class Non-Opioid Biologic for Chronic Sciatica
Key Insights
Consano Bio (search)'s C-1101 (search), a potential first-in-class disease-modifying biologic for chronic sciatica, received FDA IND clearance to expand its Phase 1 trial into the United States.
C-1101 (search) is a platelet-derived multi-protein biologic delivered via epidural injection, designed to modulate inflammation and stimulate cellular repair at the site of nerve injury.
The ongoing Phase 1 study (NCT07264270) is a multi-center, randomized, controlled, double-blinded, dose-escalation trial enrolling 24 patients across three sequential cohorts.
Consano Bio (search), Inc., a clinical-stage biotechnology company based in Burlington, Massachusetts, announced on July 20, 2026 that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for C-1101 (search), a potential first-in-class, disease-modifying, non-opioid biologic therapy for chronic painful lumbosacral radiculopathy (LSR), commonly known as chronic sciatica. The clearance authorizes the expansion of the company's ongoing Phase 1 clinical trial to include U.S. clinical sites, complementing the study already underway in Australia.
"IND clearance is a significant step forward for Consano and reflects the rigor of the program we have built," said Andrew Hall, Chief Executive Officer of Consano Bio (search). "From our founding in 2023, we have engaged the FDA continuously and constructively. IND clearance confirms that C-1101 (search) meets the high scientific and manufacturing standards required to begin clinical development in the United States."
A Novel Mechanism of Action
C-1101 (search) represents a departure from conventional therapies for chronic sciatica, which primarily provide temporary pain relief or require invasive surgical procedures. The investigational therapy is a platelet-derived, multi-protein biologic therapeutic designed to address the underlying biology of chronic LSR by modulating inflammation and stimulating and enhancing cellular repair at the site of injury.
The product contains consistent concentrations of cytokines, growth factors, and matrix proteins intended to trigger the body's natural healing response. Delivered via a single epidural injection, C-1101 (search) is designed to provide supraphysiologic concentrations of these proteins directly to the site of nerve injury.
"C-1101 (search) is a potential first-in-class, disease-modifying, non-opioid modality that targets the root biology of chronic sciatica, a condition affecting millions with no FDA-approved pharmaceutical treatment," Hall stated. "We expect to begin dosing U.S. patients in the coming months and intend to build on our strong relationship with the agency as we move C-1101 through U.S. development toward registration and approval."
Phase 1 Trial Design
The Phase 1 study (C-1101 (search)-101, NCT07264270) is a multi-center, randomized, controlled, double-blinded, dose-escalation trial designed to evaluate the safety and tolerability of C-1101 in patients with chronic sciatica. The study is enrolling 24 symptomatic patients across three sequential dose-escalation cohorts, with each participant receiving a single epidural injection.
Beyond safety and tolerability, additional assessments include measures of change in pain, physical function, and sleep quality — all key indicators of clinical improvement in chronic, painful LSR. The first patient in the trial was successfully dosed, as announced by the company on May 26, 2026.
"People living with chronic lumbosacral radiculopathy (search) have limited treatment options and often struggle to find lasting relief," said Paul Verrills, MD, lead investigator in Australia for the C-1101 (search)-101 study and founder of MetroPain in Melbourne, Australia. "We are eager to evaluate C-1101 in a clinical setting to better understand its safety profile and therapeutic potential. This trial represents an important step toward identifying new approaches for a condition that has been underserved for far too long."
Unmet Medical Need
Chronic, painful LSR is a lower back pain condition caused by damage or irritation of spinal nerve roots in the lower back, leading to radiating pain, numbness, and weakness from the spine into the leg. For many patients, these symptoms are disabling, limiting mobility and quality of life. Despite its prevalence and widespread societal and economic impact, there are currently no FDA-approved pharmaceutical treatments for chronic sciatica.
Consano Bio (search), founded in 2023 and headquartered in the Greater Boston area, is dedicated to transforming the treatment of painful and debilitating orthopedic conditions through a new class of multi-protein biologic therapeutics.