SpineThera receives u.s. patent covering sustained-release injectable corticosteroid, sx600, a non-opioid drug in development for low back pain

SpineThera’s clinical development program for SX600 will evaluate sustained-release, injectable treatment options for pain in and near the spine

Minneapolis, MN – August 22, 2019 - SpineThera, Inc., a privately held, clinical stage pharmaceutical company, announced today that the United States Patent and Trademark Office has issued Patent 10,350,222 related to its non-opioid, sustained-release drug technology.  

“As we continue to develop our lead drug, SX600, a sustained-release, injectable, micro-suspension corticosteroid to address the unique requirements of an epidural injection to treat back pain, this new patent strengthens and broadens our intellectual property portfolio,” said Jeff Missling, Founder and CEO of SpineThera.

Patent No. 10,350,222 provides composition of matter protection for SX600 and complements previously issued U.S. Patent Nos. 8,927,529 and 9,572,771, which provide protection to methods of treatment. The active ingredient in SX600 is dexamethasone acetate, which has been reformulated into an injectable micro-suspension containing microparticles that are smaller than the particles in a standard corticosteroid suspension and smaller than a red blood cell. The active drug is encapsulated within these tiny biodegradable microparticles, which provide sustained release delivery of dexamethasone.  

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.

“We are extremely pleased with the continued evolution of the patent portfolio of SX600” said Paul Medeiros, president of Imbrium Therapeutics. “The issuance of this new patent acknowledges the novelty of this formulation, and its availability will support our work to meet the important medical need for non-opioid alternatives for the treatment of chronic pain.”

“We are pleased with the progress in the development of SpineThera’s novel steroid product for epidural injection for patients who suffer from low back pain,” said Craig Landau, MD, President and CEO, Purdue Pharma. “We are committed to alleviating pain through new and innovative non-opioid medicines. SX600 represents an example of our commitment to address the evolving needs of patients and their healthcare providers through the research & development of non-opioid solutions.”

This press release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that SX600, an investigational agent, will successfully complete development or gain FDA approval.

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.

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 oncology chemotherapeutics, treatments for disorders of the central nervous system, and non-opioid approaches to the management of pain. 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.