Semnur Initiates Phase 3 Clinical Trial to assess its SP-102 in lumbar radicular pain/sciatica afflicted patients

Semnur Pharmaceuticals announced the commencement of phase 3 clinical trials in the U.S to evaluate its product SP-102 in patients suffering from lumbar radicular pain/sciatica. It is also worth taking note of that FDA has issues SP-102 Fast track designation to diagnose the same.

SP-1-2 developed as a viscous gel injection to diagnose lumbar radicular pain/sciatica devoid of neurotoxic preservatives, surfactants, solvents or particulates.  400 patients with lumbar radicular pain at up to 35 sites across the U.S will undertake the phase 3 trial. The primary endpoint of the study is mean change in the Numerical Pain Rating Scale for leg pain compared to intramuscular injection of placebo over four weeks.  The secondary endpoints enumerate other measures of pain at 4 and 12 weeks as well as time to repeat injection of SP-102, safety, and disability mainly to curate a database of patients treated with SP-102 safely. The fast-track program was executed to accelerate development and regulatory review of therapeutic programs seeking to address medical needs that are usually unmet.  Semnur authorizes to further communicate to the FDA   on issues related to the drug development plans and data in order to accelerate the cure for non- opioid pain.

Jaisim Shah, Chief Executive Officer, Semnur Pharmaceuticals said “On the heels of our successful Phase 1 / 2 bridging study results, we are excited to be starting our pivotal Phase 3 CLEAR trial to evaluate how a single epidural injection of SP-102 relieves sciatica pain. We’ve received significant interest from physicians to participate in this trial, looking for treatment alternatives for their patients without the burden of opioids.”