Semnur Pharmaceuticals has started a Phase lll clinical trial of SP-102 to treat patients with lumbar radicular pain, also known as sciatica.
As part of the randomised, double-blind, placebo-controlled trial named ‘Corticosteroid Lumbar Epidural Analgesia for Radiculopathy’ (CLEAR), 400 patients with lumbar radicular pain will be enrolled at around 35 sites across the US.
The trial’s primary endpoint is to achieve a mean change in the numerical pain rating scale for leg pain compared to intramuscular injection of placebo over four weeks.
Secondary endpoints of the trial include other measures of pain at four and 12 weeks, as well as time to repeat the SP-102 injection, safety, and disability.
The CLEAR trial features an open-label extension to build the safety database of patients treated with SP-102, which is a non-opioid corticosteroid formulated as a viscous gel injection.
SP-102 has received the fast-track designation from the US Food and Drug Administration (FDA) for use in the treatment of lumbar radicular pain.
Semnur Pharmaceuticals chief medical officer Dr Dmitri Lissin said: “Patients with lumbosacral spinal conditions return frequently to their doctors looking for pain relief.
“We are eager to investigate what may be the first FDA-approved epidural injection that the interventional pain physicians could offer their patients for persistent relief of their pain, caused by nerve root compression usually by herniated intervertebral discs.
“We designed SP-102 to address expectations of medical community for a safer and longer-lasting injectable medication to reduce inflammation and pain.”
In addition, Semnur reported successful results from a Phase l/ll bridging study of SP-102 in patients with lumbar radicular pain.
The trial has achieved its primary pharmacokinetic endpoint of an extended product residency time at the site of injection and showed how a single dose of SP-102 led to an improvement of more than 30% in leg and back pain over 30 days.