Research & Development
Semnur Pharmaceuticals Initiates Phase 3 Trial of SP-102 in Lumbar Radicular Pain/Sciatica
11 January 2018 - - Mountain View, California-based clinical stage specialty pharmaceutical company Semnur Pharmaceuticals, Inc. has initiated a Phase 3 clinical trial in the US to evaluate its lead product SP-102 in patients with lumbar radicular pain/sciatica, the company said.
In addition, the US Food and Drug Administration has granted SP-102 fast track designation for the treatment of lumbar radicular pain/sciatica.
SP-102 is a non-opioid corticosteroid formulated as a viscous gel injection, designed to prolong its analgesic effect at the site of the epidural injection, as demonstrated in clinical and preclinical studies. SP-102 does not contain neurotoxic preservatives, surfactants, solvents or particulates, which is expected to result in a better safety profile than commonly used off-label injected corticosteroids.
The CLEAR (Corticosteroid Lumbar Epidural Analgesia for Radiculopathy) clinical study is a randomized, double-blind, placebo-controlled Phase 3 trial that will enroll 400 patients with lumbar radicular pain at up to 35 sites across the US.
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 include other measures of pain at 4 and 12 weeks as well as time to repeat injection of SP-102, safety and disability.
The study includes an open-label extension to build the safety database of patients treated with SP-102.
Semnur's successful Phase 1/2 bridging study in patients with lumbar radicular pain achieved its primary pharmacokinetic endpoint of an extended product residency time at the site of injection, as well as demonstrated that a single injection of SP-102 led to over 30% improvement in leg and back pain over 30 days. Semnur's pivotal Phase 3 CLEAR trial is designed to satisfy regulatory requirements for a 505(b) (2) new drug application with the FDA.
Semnur Pharmaceuticals is focused on the development and commercialization of best in class novel non-opioid pain therapies. Semnur's lead program, SP-102, is a non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica.