Semnur Pharmaceuticals touted data today from a Phase I/II pharmacokinetic trial of its injectable, non-opioid pain-killer, SP-102. The trial enrolled 12 patients with radicular pain.
The trial met its primary endpoint and showed that single epidural injection of SP-102 could provide a sustained analgesic effect for 1 month.
The company touted its product, which is delivered via epidural injection, as the 1st non-opioid gel formulation in development for lumbar radicular pain.
“We are very excited with the data from this 1st-in-human proof-of-principle study, which allows us to proceed with the planned Phase III safety and efficacy trials in the U.S. SP-102 is designed to address the limitations of existing steroid formulations, which are used off-label for the treatment of lumbar radicular pain, and has a strong potential to meet the current unmet medical needs,” Dr. Dmitri Lissin, chief medical officer, said in prepared remarks. “We anticipate sharing more details from the Phase I/II trial at upcoming meetings and with the expectation to start the pivotal multi-center U.S. Phase III trial this year.”
There were no serious adverse events and the injections were well tolerated, according to Semnur. Over the course of 1 month, patients reported an average 20% to 40% reduction of daily average back and leg pain.
“We believe these data validate our novel program and bolster our confidence that SP-102 can provide radicular pain/sciatica patients with persistent and prolonged pain relief. Lumbar radicular pain, otherwise known as sciatica, is commonly treated by off-label epidural steroid injections. There are an estimated 10 to 11 million epidural steroid injections administered per year in the U.S. alone,” CEO Jaisim Shah added. “These clinical results are our 1st seminal milestone for Semnur and provide encouraging news for the many millions of people who are confronting chronic radicular pain/sciatica. The pain associated with radicular/sciatica can be debilitating, and we believe that SP-102 could be the first approved non-opioid treatment option for patients suffering from this painful progressive condition.”
“At a time of opioid epidemic in U.S.A. and 100 million patients with chronic pain, it is encouraging to see new non-opioid formulations being developed for use by interventional pain physicians,” Dr. Asokumar Buvanendran, from Rush University Medical Center, said.
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