Burlington, Massachusetts, U.S., September 10, 2026
Consano Bio, Inc. has announced the publication of peer-reviewed nonclinical research evaluating C-1101, the company’s lead investigational therapeutic for chronic painful lumbosacral radiculopathy (LSR), commonly known as chronic sciatica. The research, published in Frontiers in Bioengineering and Biotechnology, evaluated the biological activity of C-1101 across in vitro and in vivo models and found evidence of immunomodulatory activity, reduced inflammation, cellular repair and reduced neuropathic pain. The findings support the continued clinical development of C-1101, which is currently being evaluated in a randomized, double-blind Phase 1 clinical trial in patients with chronic painful LSR.
C-1101 Shows Anti-Inflammatory and Repair Activity
The published research investigated the effects of C-1101 using laboratory and animal models designed to examine mechanisms relevant to chronic sciatica. C-1101 is a novel platelet-derived multi-protein biologic therapeutic containing consistent concentrations of cytokines, growth factors and matrix proteins. The investigational treatment is designed to modulate inflammation while stimulating and enhancing cellular repair and tissue regeneration at the site of nerve injury. In vitro studies using annulus fibrosus and nucleus pulposus cells from sheep discs showed that C-1101 produced immunomodulatory effects, including changes in the release of both pro-inflammatory and anti-inflammatory cytokines. Researchers also observed changes in pathways associated with inflammation, extracellular matrix activity and cell growth. C-1101 downregulated interferon signaling and extracellular matrix pathways while upregulating pathways associated with the cell cycle and replication, findings that may support further investigation of its potential effects on tissue repair. Additional analysis in dorsal root ganglia showed downregulation of interferon-gamma and other inflammatory pathways, providing further evidence of potential anti-inflammatory and immunomodulatory activity in nerve cells. These mechanistic findings are relevant because chronic painful LSR is associated with nerve-root injury and inflammation that can produce persistent radiating pain.
C-1101 Reduces Neuropathic Pain in Animal Model
The research also examined the functional effects of C-1101 in an in vivo murine model of paclitaxel-induced neuropathic pain. Systemic administration of C-1101 reduced neuropathic cool allodynia at both doses evaluated, providing a functional measure of reduced pain sensitivity. The treatment also produced transient increases in cytokines, while the higher dose reduced markers associated with macrophage and microglial activation in sciatic nerves. According to Consano Bio, the combination of laboratory and animal findings supports the hypothesis that C-1101 could potentially address underlying disease biology rather than pain symptoms alone. The company is investigating whether modulation of inflammation and stimulation of cellular repair can provide a therapeutic approach for patients with chronic painful LSR. However, the published findings remain nonclinical evidence and do not establish that C-1101 will demonstrate comparable efficacy or safety in humans. The company noted that the observed cytokine response warrants additional investigation into the treatment’s mechanism of action.
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Phase 1 Trial Advances C-1101 Clinical Development
Consano Bio is advancing C-1101 in a randomized, double-blind Phase 1 study, designated C-1101-101, in patients with chronic painful LSR. Each participant receives a single epidural injection of the investigational therapy. The clinical program represents the next step in determining whether the biological activity observed in preclinical models can translate into a clinically meaningful therapeutic effect in patients. Chronic painful LSR, or chronic sciatica, occurs when spinal nerve roots in the lower back are damaged or irritated, potentially causing pain, numbness and weakness that radiate from the lower back into the leg. Despite its prevalence and substantial impact on patients, Consano Bio notes that there are currently no FDA-approved pharmaceutical treatments specifically for chronic sciatica. C-1101 has received FDA Fast Track designation and is being developed as an investigational pharmaceutical approach intended to deliver a concentrated combination of proteins directly to the site of nerve injury through an epidural injection. The newly published research provides additional mechanistic evidence supporting the program as it progresses through early clinical development. The forthcoming clinical data will be important in determining whether the anti-inflammatory, immunomodulatory and cellular repair effects observed in preclinical studies can translate into improved outcomes for patients living with chronic painful LSR.
Source: Consano Bio press release
