– Pharmacokinetic data supports previous preclinical results, demonstrating an extended product residency time at the site of epidural injection
– Single epidural injection of SP-102 resulted in sustained analgesic effect, lasting over the entire observational period of one month
– SP-102 is a novel injectable gel formulation containing no particulates, solids, surfactants or preservatives in the drug product
LOS ALTOS, Calif., June 26, 2017 /PRNewswire/ — Semnur Pharmaceuticals, Inc. (“Semnur”) today announced successful Phase 1 / 2 pharmacokinetic bridging trial of the lead product SP-102. The trial was conducted in the patients with radicular pain, achieved its primary pharmacokinetic endpoint, and also demonstrated that a single epidural injection of SP-102 can lead to a sustained analgesic effect lasting one month.
SP-102 is the first non-opioid novel gel formulation in development for the treatment of lumbar radicular pain, containing no neurotoxic preservatives, surfactants, solvents or particulates. The SP-102 formulation is administered by epidural injection and extends the residency time at the site of injection based on preclinical and patient studies.
“We are very excited with the data from this first-in-human proof-of-principle study, which allows us to proceed with the planned Phase 3 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. We anticipate sharing more details from the Phase 1/2 trial at upcoming meetings and with the expectation to start the pivotal multi-center U.S. Phase 3 trial this year,” said Dmitri Lissin, MD, Chief Medical Officer of Semnur.
The trial also showed that adverse events were comparable between the two treatments. There were no serious adverse events (SAE) and SP-102 injections were well tolerated. The single epidural injection of SP-102 showed a clear trend in a sustained analgesic effect, lasting over the entire observational period of one month, demonstrated by Mean 20-40 percent reductions of daily average back and leg pain in 12 subjects enrolled in the study.
In the U.S., more than 30 million people live with low back and radicular pain, with this population expected to grow in the low-single digit percentages annually.3,4 Many patients experience pain at moderate-to-severe levels with intolerance and/or inadequate response to current analgesic therapies such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs).5,6 There is a great need for highly effective analgesic medications to provide patient relief without the toxicity and tolerability challenges of NSAIDs and opioids.4 Opioid prescriptions account for about 40 percent of the chronic pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternative pain therapies without the medical and societal challenges.4,7
“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 ten to eleven million epidural steroid injections administered per year in the U.S. alone.1 These clinical results are our first 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,” said Jaisim Shah, Chief Executive Officer of Semnur Pharmaceuticals, Inc.
“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,” said Asokumar Buvanendran, MD, Vice Chair, Research & Director of Orthopedic Anesthesia, Professor, Department of Anesthesiology at Rush University Medical Center, Chicago.
About Semnur Pharmaceuticals Inc.
Semnur Pharmaceuticals, Inc. is a clinical-stage specialty pharmaceutical company based in Los Altos, CA, 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. For more information, visit www.semnurpharma.com.
About Scintilla Pharmaceuticals, Inc. and Semnur Pharmaceuticals, Inc. acquisition
On August 15, 2016, Scintilla Pharmaceuticals, Inc. (“Scintilla”), a subsidiary of Sorrento Therapeutics, Inc. (NASDAQ: SRNE) (“Sorrento”), has entered into a binding term sheet to acquire Semnur Pharmaceuticals, Inc. (“Semnur”). Scintilla’s lead program is Resiniferatoxin (“RTX”) for the treatment of intractable cancer pain. Semnur’s lead product, projected to commence Phase 3 clinical trials in 2017, is a non-opiate epidural steroid injectable gel to treat radicular pain. “Semnur represents a unique asset for Scintilla that is highly complementary to its existing assets. Semnur’s pipeline of late-stage and near commercialization product opportunities targets some of the largest pain markets available and addresses critical unmet medical needs,” said Dr. Henry Ji, President and CEO of Sorrento. The acquisition is pending contingent upon customary closing conditions. For more information, visit www.scintillapharma.com.
This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Semnur Pharmaceuticals, Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the outcome of the data from a clinical trial for SP-102, Semnur’s prospects, future clinical trials and the results thereof, market and patient population trends, M&A strategy and the pending acquisition by Scintilla, and ability to accelerate the development of its lead program in the clinic. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to that SP-102 may not meet all endpoints of the clinical study and that the data may not support an NDA submission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as may be required by law.
Stephen H. Ma
Semnur Pharmaceuticals, Inc.
4970 El Camino Real, Suite 205
Los Altos, CA 94022
Main: (888) 315-8706
(1) NEJM July 3, 2014 Editorial: Epidural Glucocorticoid Injections in Patients with Lumbar Spinal Stenosis; Gunnar B.J. Andersson, M.D., Ph.D
(2) Institute of Medicine, National Center for Health Statistics, and Datamonitor December 2009
(3) Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 76 & 80
(4) Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 40
(5) Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 62
(6) Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 62
(7) Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 8
SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc. A proprietary name review by the FDA is planned.
SEMNUR PHARMACEUTICALS™ is a trademark owned by Semnur Pharmaceuticals, Inc.
All other trademarks and trade names are the property of their respective owners.