The IND clearance authorizes expansion of Consano Bio’s ongoing Phase 1 clinical trial to include U.S. clinical sites, complementing the study currently underway in Australia. The multi-center, randomized, controlled, double-blinded Phase 1 study (C-1101-101, NCT07264270) is evaluating C-1101 in patients with chronic sciatica. The study is enrolling symptomatic patients across three sequential, dose-escalation cohorts with each participant receiving a single epidural injection.

“IND clearance is a significant step forward for Consano and reflects the rigor of the program we have built,” said Andrew Hall, Chief Executive Officer of Consano Bio. “From our founding in 2023, we have engaged the FDA continuously and constructively. IND clearance confirms that C-1101 meets the high scientific and manufacturing standards required to begin clinical development in the United States. C-1101 is a potential first-in-class, disease-modifying, non-opioid modality that targets the root biology of chronic sciatica, a condition affecting millions with no FDA-approved pharmaceutical treatment. We expect to begin dosing U.S. patients in the coming months and intend to build on our strong relationship with the agency as we move C-1101 through U.S. development toward registration and approval.”