SpineThera announces first patient dosed in salient phase 1/2 clinical study sx600, an investigational non-opioid epidural steroid injection is being evaluated for the treatment of sciatica

MEDICAL ALLEY, Minnesota. – November 25, 2019 –SpineThera, Inc., and its subsidiary SpineThera Australia Pty Ltd, announced today the first dose has been administered in the SALIENT (Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain) Phase 1/2 clinical study of SX600, a non-opioid epidural steroid injection in development for the treatment of sciatica.

Jeff Missling, founder and CEO, SpineThera, said, “The first patient dosed in the SALIENT Phase 1/2 clinical study represents an important step in the development of this innovative medication, which, if approved by the FDA, could represent the first and only steroid injection indicated for epidural administration.”

SALIENT is a double-blind, randomized, placebo-controlled, parallel-group, first-in-human study evaluating the efficacy and safety of two doses (12.5 mg and 25 mg) of SX600 as a sustained-release, injectable treatment option for pain in and near the spine.

In October 2018, Purdue Pharma L.P. and SpineThera, Inc.  announced that the companies entered into an agreement that provides Purdue the exclusive option to acquire SpineThera, Inc. and gain worldwide rights to its products and technology platforms, including lead asset SX600.  Imbrium Therapeutics was founded in 2019 as an operating subsidiary of Purdue Pharma. With its distinct mission, therapy area focus, and leadership team, Imbrium is committed to applying its capabilities in science and medicine to rapidly advance the development of new, favorably differentiated therapeutic agents in the areas of cancer, CNS and non-opioid pain.

“The first patient dosed with SX600 is an exciting moment in the investigation of this novel, sustained-release, injectable, micro-suspension corticosteroid, and brings us closer to our goal of addressing the unique requirements of an epidural injection to treat back pain,” said Paul Medeiros, president of Imbrium Therapeutics. “This is an important milestone as we seek to understand the capabilities of SX600, in treating this potentially debilitating condition[i].”

“Most people will experience a form low back pain, such as sciatica, at some point in their lifetime, and it is the most common cause of job-related disability, as well a leading contributor to missed work days.[ii] With the SALIENT clinical study, we seek to address this important unmet medical need,” said Craig Landau, MD, president and CEO, Purdue Pharma L.P. “The SX600 clinical development program aligns with Imbrium’s focus to rapidly advance the development of non-opioid alternatives to treat pain.”

To learn more about the study, please visit clinicaltrials.gov.

About SpineThera

SpineThera designs and develops sustained-release, injectable drugs to meet the unique safety requirements for administration in and near the spine. Our goal is to develop proprietary drugs that offer patients and physicians new treatment options that reduce risk, improve outcomes, and manage overall treatment costs in markets with few or no approved drugs. SX600, our lead product candidate, is an investigational drug. SpineThera, Inc., is based in Medical Alley, Minnesota, the global epicenter of health innovation and care. SpineThera Australia Pty Ltd is a wholly owned subsidiary of SpineThera, Inc., and is the sponsor of the SALIENT study.

About Imbrium Therapeutics L.P.

Imbrium is a clinical-stage biopharmaceutical company dedicated to advancing medical science through the development of important new pharmacologic and biologic therapeutics. We are pursuing non-opioid approaches to the management of pain, oncology chemotherapeutics, and treatments for disorders of the central nervous system. As an operating subsidiary of Purdue Pharma L.P., Imbrium strives to develop and bring to market new medicines that serve the unmet needs of patients, physicians and health systems worldwide. We have built a robust and diversified pipeline of investigational drug candidates, and we actively collaborate with industry and academic partners to identify and advance future impactful medicines. For more information, please visit www.imbriumthera.com.

[i] American Association of Neurological Surgeons. Low Back Pain. August 2019. Accessed Sept 4, 2019. Retrieved from https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Low-Back-Pain.

[ii]  National Institute of Neurological Disorders and Stroke. Low Back Pain Fact Sheet. August 2019. Accessed Aug 29, 2019. Retrieved from https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Low-Back-Pain-Fact-Sheet#3102_10.