Designation follows recent FDA clearance of the Company's IND application for C-1101, an investigational, potentially disease-modifying non-opioid biologic

BURLINGTON, Mass., Aug. 18, 2026 /PRNewswire/ -- Consano Bio, Inc., a clinical-stage biotechnology company advancing novel therapeutics designed to address serious, painful orthopedic conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to C-1101, the Company's lead investigational, platelet-derived biologic for the treatment of chronic, painful lumbosacral radiculopathy (LSR), commonly known as chronic sciatica. Presently, there are no FDA-approved pharmaceutical therapies indicated to treat LSR.

LSR represents a clinically significant subset of low back pain and is the leading cause of years lived with disability in the U.S.¹ and accounts for more U.S. health care spending than any other condition, at an estimated $135 billion annually.² It is also a major driver of opioid initiation and chronic opioid use in the U.S.³, and for many patients, persists for years and can progress to irreversible nerve damage and permanent disability. Beyond the association with opiate use, LSR is also strongly associated with depression, anxiety, and rates of suicidal ideation well above those of the general population.

"Fast Track Designation underscores the significant unmet need in chronic sciatica, a serious and debilitating condition," said Andrew Hall, Chief Executive Officer of Consano Bio. "C-1101 is designed to address the underlying biology of nerve injury rather than simply manage pain. We look forward to close collaboration with the FDA as we advance C-1101 through our ongoing Phase 1 study as a potential new treatment option for these patients."

The designation was granted based on the unmet needs in LSR and the comprehensive nonclinical data package submitted in support of C-1101's clinical potential. The FDA's Fast Track program is designed to facilitate development and expedite review of therapies intended to treat serious conditions and address significant unmet medical needs.

Consano Bio is currently advancing C-1101 in a multi-center, randomized, controlled, double-blind Phase 1 study (C-1101-101, NCT07264270) in symptomatic patients with chronic painful LSR across three sequential, dose-escalation cohorts with each participant receiving a single epidural injection. The study is enrolling in Australia and is extending into the United States following FDA clearance of the Company's Investigational New Drug (IND) application in July 2026.

About Chronic Lumbosacral Radiculopathy (LSR)
Chronic, painful LSR, or chronic sciatica, is a chronic 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. There are no FDA-approved pharmaceutical treatments for chronic sciatica despite its prevalence and widespread societal and economic impact.

About C-1101
C-1101 is Consano Bio's lead investigational clinical candidate and the first pharmaceutical therapy of its kind in development: a novel, platelet-derived multi-protein biologic therapeutic. It is designed to treat LSR, or chronic sciatica, 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 designed to help trigger the body's natural healing response. Delivered via an epidural injection, C-1101 is intended to provide supraphysiologic concentrations of these proteins directly to the site of nerve injury.

About Consano Bio
Consano Bio is a clinical-stage biotechnology company dedicated to transforming the treatment of painful and debilitating orthopedic conditions through a new class of multi-protein biologic therapeutics. For more information, visit www.consanobio.com.

Contacts:

Consano Bio
Rahul Bansal
VP, Finance & Investor Relations
rbansal@consanobio.com
(908) 230-6689

Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
(231) 632-0002
dirish@tiberend.com 

Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
(646) 577-8520
cmcdonald@tiberend.com

¹JAMA. 2018;319(14):1444-1472. doi:10.1001/jama.2018.015
²Dieleman JL, et al. JAMA. 2020;323(9):863-884. doi:10.1001/jama.2020.0734
³Deyo RA, Von Korff M, Duhrkoop D. Opioids for low back pain. BMJ. 2015;350:g6380. doi:10.1136/bmj.g6380

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SOURCE Consano Bio