Targeting the Root of Pain: A New Era for Chronic Sciatica Therapeutics

Chronic lumbosacral radiculopathy, also known as chronic sciatica, has long challenged clinicians and patients alike, with no FDA-approved pharmaceutical therapies available and existing treatments offering only temporary relief. Consano Bio is shifting that paradigm with a novel approach: a novel, platelet-derived multi-protein biologic therapeutic (C-1101) in development as a potential first-in-class, non-opioid, designed to address the biology of nerve injury and inflammation at its source.

 

Founded in 2023 and headquartered in the Greater Boston area, Consano Bio is dedicated to transforming the treatment of painful and debilitating orthopedic conditions. With the first patient now dosed in a Phase 1 clinical trial, this strategy reflects broader innovation in drug development focused on localized, disease-modifying therapies for chronic nerve-related pain.

 

In this Bench2Bedside conversation, we speak with CEO Andrew Hall about Consano Bio’s transition into the clinic, marked by first patient dosed in its Phase 1 study, and the implications for treating nerve-related pain.

Bench2Bedside: Tell our readers a bit about Consano Bio and the scientific rationale behind your off-the-shelf, platelet-derived growth factor approach to treating chronic lumbosacral radiculopathy.

Andrew Hall:
Consano Bio was founded around a simple but underexplored idea: many chronic pain conditions, including lumbosacral radiculopathy, are driven by localized biological injury that never properly resolves. Platelets and plasma proteins play a central role in normal healing, inflammation resolution, and tissue repair, yet most therapies for chronic sciatica ignore these pathways entirely.

Our approach builds on decades of biological understanding, including the long-standing clinical interest in platelet-rich plasma, which has explored the role of platelet-derived factors in supporting tissue repair. What has been missing is pharmaceutical standardization and reproducibility. Rather than relying on variable, clinic-prepared or patient-specific products, C-1101 is a purified,  multi-protein biologic derived from human platelets in plasma collected from healthy donors, containing consistent concentrations of cytokines, growth factors, and matrix proteins. Delivered via an epidural injection, C-1101 provides supraphysiologic concentrations — well above the body’s natural levels — of these proteins directly to the site of nerve injury. The goal is to shift the local environment from chronic inflammation toward repair, addressing the underlying biology of the disease rather than masking symptoms.

 

B2B: You recently announced that the first patient has been dosed in your Phase 1 clinical trial for the treatment of chronic sciatica. Can you walk us through the design of this study and what this milestone represents for Consano and the broader development program?

Andrew Hall:
Thank you. This is an important milestone for us because it marks our transition from a research-focused organization to a clinical-stage company. The study is a multicenter, randomized, controlled, blinded Phase 1 trial (C-1101-101, NCT07264270) designed to evaluate the safety and tolerability of C-1101 following a single epidural injection.  In addition to safety, the study incorporates exploratory clinical endpoints relevant to future regulatory development, including measures of pain, physical function, and sleep quality, to help inform dose selection and guide subsequent trials. Patients are enrolled across three sequential cohorts, with the study designed to enroll 24 patients in total, with each cohort receiving a different dose level, allowing us to carefully assess dose escalation while limiting exposure to a single administration per participant.

From a broader perspective, dosing the first patient validates years of scientific, manufacturing, and regulatory work. It also establishes the clinical foundation we’ll need to evaluate biological activity and, ultimately, whether targeting the root causes of nerve injury can translate into meaningful benefit for patients with chronic sciatica.

 

B2B: Chronic lumbosacral radiculopathy affects millions of patients worldwide, yet treatment options remain limited. Could you describe the underlying biology of the disease and why existing pharmacologic, interventional, and surgical approaches often fall short?

Andrew Hall:
Chronic lumbosacral radiculopathy is fundamentally a disease of nerve injury and persistent inflammation. In many patients, disc material or structural changes in the spine trigger an inflammatory response around the nerve root. When that inflammation doesn’t resolve, it creates a hostile microenvironment that damages the nerve and perpetuates pain, weakness, and dysfunction.

Existing treatments don’t directly address this biology. Systemic pain medications often fail to reach the site of injury in sufficient concentrations. Steroid injections can temporarily suppress inflammation but don’t promote healing and are not designed for chronic use. Device-based interventions and surgery may disrupt pain signaling or decompress anatomy, but they don’t restore nerve health. As a result, many patients cycle through treatments that offer partial or short-lived relief without changing the course of the disease. To underscore the unmet need: lower back pain including lumbosacral radiculopathy is the number one cause of disability in the U.S. and has been for three consecutive years, with the cost to the U.S. healthcare system estimated at $135 billion annually. It is also the number one reason for opioid initiation. Despite this prevalence, there are currently no FDA-approved pharmaceutical treatments for chronic sciatica.

 

B2B: Please walk us through how Consano’s platelet-derived protein therapy is designed to work mechanistically, and how delivering defined growth factors differs from more invasive interventions.

Andrew Hall:
C-1101 is designed to act locally at the site of nerve injury by delivering a concentrated and defined set of platelet- and plasma-derived proteins that are central to tissue repair. These proteins work together to modulate inflammation, support cellular repair processes, and help restore a healthier microenvironment around the affected nerve root.

The concept of using platelets to drive cellular repair and consequential therapeutic benefit, is not novel. Innovation around self-sourced (autologous) platelet rich plasma has been ongoing for decades. What differentiates our approach is consistency and control. Unlike patient-specific (autologous) or point-of-care approaches that depend on individual biology and preparation — which leads to significant variability in composition and activity — C-1101 is a, off-the-shelf product derived from healthy donors. In contrast, C-1101 is manufactured under pharmaceutical standards, allowing us to precisely characterize the product and study it rigorously in clinical trials. Compared with invasive procedures that destroy or bypass nerve function, our aim is to support healing rather than disrupt biology.

 

B2B: Looking ahead, what milestones are you hoping to achieve over the next 12 to 24 months as this trial progresses and as you continue to build momentum across the Consano pipeline?

Andrew Hall:
Our near-term focus is on executing the Phase 1 trial with rigor and discipline, generating high-quality safety and translational data that inform next steps. As the study progresses, we’re looking to better understand dose selection, biological signals of activity, and how our approach performs in a clinical setting.

In parallel, we’re continuing to strengthen the broader platform by advancing our intellectual property, manufacturing capabilities, and scientific understanding of platelet-derived multi-protein therapeutics. We presented preclinical data at the Orthopaedic Research Society 2026 Annual Meeting demonstrating C-1101’s anti-inflammatory effects in activated human immune cells, modulation of inflammatory pathways, activation of growth-related pathways, and reduced pain sensitivity in a rodent model of peripheral neuropathy — all supporting its potential for disease modification. We will also be presenting at the BIO International Convention in June 2026. Over the next 12 to 24 months, our goal is to build a solid clinical and scientific foundation that supports expansion into later-stage studies and, potentially, additional nerve-related pain indications where disease-modifying therapies are urgently needed.

Consano Bio

CEO: Andrew Hall, MS

Headquarters:  Burlington, MA

Lead Product:  C-1101

Treatment Indication: Chronic, painful lumbosacral radiculopathy (LSR), also known as chronic sciatica

Stage of Development: Phase 1