Consano Bio has received FDA investigational new drug (IND) clearance for C‑1101, allowing the company to expand its chronic sciatica clinical program into the United States.
C‑1101 is Consano’s lead investigational therapy for chronic painful lumbosacral radiculopathy (LSR), commonly known as chronic sciatica. The IND authorizes U.S. participation in the company’s ongoing Phase 1 study, which is already underway in Australia. The multi‑center, randomized, controlled, double‑blind trial (C‑1101‑101, NCT07264270) is enrolling symptomatic patients across three sequential dose‑escalation cohorts, with each participant receiving a single epidural injection of C‑1101.
Consano said the clearance reflects continued engagement with the FDA since the company’s founding in 2023 and confirms that the program meets required scientific and manufacturing standards for U.S. clinical testing. The company expects to begin dosing U.S. patients in the coming months.
Chronic sciatica affects millions of people and currently lacks any FDA‑approved pharmaceutical treatment specifically targeting the condition. Existing approaches generally focus on temporary pain relief or invasive procedures. C‑1101 is being developed as a potential first‑in‑class, disease‑modifying, non‑opioid therapy aimed at the underlying biology of chronic LSR rather than only symptom control.
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