BURLINGTON, Mass., July 20, 2026
Consano Bio has announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for C-1101, the company’s lead investigational therapy for chronic painful lumbosacral radiculopathy (LSR), commonly known as chronic sciatica. The regulatory milestone enables the biotechnology company to expand its ongoing Phase I clinical trial into the United States, complementing the study currently being conducted in Australia. Designed as a potential first-in-class, disease-modifying, non-opioid biologic therapy, C-1101 targets the underlying biological causes of chronic sciatica rather than simply providing temporary pain relief. The IND clearance represents a major advancement for Consano Bio as it seeks to address a significant unmet medical need affecting millions of patients worldwide who currently have no FDA-approved pharmaceutical treatment for chronic sciatica.
FDA Clearance Expands U.S. Clinical Development Program
The FDA IND clearance authorizes Consano Bio to begin enrolling patients at U.S. clinical sites as part of its ongoing Phase I randomized, controlled, double-blinded, multi-center study (C-1101-101). The trial is evaluating the safety, tolerability, and preliminary clinical activity of C-1101 in patients diagnosed with chronic painful lumbosacral radiculopathy. Participants are being enrolled into three sequential dose-escalation cohorts, with each patient receiving a single epidural injection of the investigational therapy. Expanding the study into the United States is expected to accelerate clinical development while generating additional safety and efficacy data to support future regulatory submissions. Company leadership noted that continuous collaboration with the FDA since Consano Bio’s founding has helped establish the scientific and manufacturing standards necessary to advance the program into U.S. clinical testing.
Novel Biologic Targets the Root Cause of Chronic Sciatica
Unlike conventional therapies that primarily focus on short-term pain management through analgesics, corticosteroids, or invasive surgical procedures, C-1101 is designed to directly target the underlying biological mechanisms responsible for chronic nerve injury. The investigational therapy is a platelet-derived multi-protein biologic containing carefully controlled concentrations of cytokines, growth factors, and extracellular matrix proteins intended to modulate inflammation while stimulating tissue repair and nerve healing. Administered through a targeted epidural injection, the therapy delivers supraphysiologic levels of regenerative proteins directly to the site of nerve damage. By promoting the body’s natural healing response rather than masking symptoms, C-1101 has the potential to become the first disease-modifying pharmaceutical therapy specifically developed for patients suffering from chronic sciatica.
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Addressing a Significant Unmet Need in Pain Management
Chronic lumbosacral radiculopathy, commonly referred to as chronic sciatica, is one of the most prevalent causes of persistent lower back and leg pain, resulting from irritation or injury to spinal nerve roots. Patients frequently experience radiating pain, numbness, tingling, and muscle weakness that significantly impair mobility and quality of life. Despite affecting millions of individuals globally, there are currently no FDA-approved pharmaceutical therapies specifically indicated for chronic sciatica, leaving patients dependent on pain medications, steroid injections, physical therapy, or surgery. Consano Bio’s development strategy positions C-1101 as a potentially transformative treatment capable of changing the long-term management of this debilitating condition. With U.S. clinical development now authorized, the company expects to initiate patient dosing in the coming months while continuing to advance C-1101 toward later-stage clinical trials, regulatory approval, and eventual commercialization.
Source: Consano Bio press release
