The FDA has granted fast-track designation to Consano Bio’s C-1101, an investigational biologic for chronic sciatica.
C-1101 is being developed to treat chronic painful lumbosacral radiculopathy, or chronic sciatica. The epidural injection is a platelet-derived biologic designed to address inflammation and promote cellular repair at the site of nerve injury. There are currently no FDA-approved pharmaceutical treatments indicated for the condition, according to an Aug. 18 news release from the company.
The designation follows the FDA’s clearance in July of Consano Bio’s investigational new drug application for C-1101. The agency’s fast-track program is intended to expedite the development and review of therapies for serious conditions with unmet medical needs.
Consano Bio is evaluating C-1101 in a randomized, controlled, double-blind phase 1 study of patients with chronic sciatica. The study is enrolling patients in the U.S. following the FDA’s clearance of the investigational drug application, the release said.
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