SpineThera Awarded $5 Million Grant From Department of Defense

April 26, 2022

SpineThera Awarded $5 Million Grant From Department of Defense

Plymouth, Minnesota, United States, April 26, 2022 – SpineThera, Inc., a privately held, clinical stage pharmaceutical company focused on the development of SX600 (a novel formulation of sustained-release dexamethasone for treatment of lumbar radiculopathy) announced today that the Department of Defense has awarded the company a grant for $4.97 million that will support development of SX600.  The scope of work supported by this grant award includes nonclinical toxicity testing of SX600 and manufacturing process development and scale-up activities.  Together, these activities will position SX600 for future Phase 3 clinical trials.

Emily Meyering, Vice President of Research and Development stated “Over one in three Americans experiences back pain annually, resulting in suffering and significant expense. Low back pain is of great concern for U.S. military populations, with an overall incidence among active-duty service members of 40.5 per 1000 person-years, with Army soldiers at the greatest risk. SpineThera is committed to bringing a safe and efficacious drug to market, and the incredible support from the Department of Defense will maintain the great product development momentum for SX600 as we look ahead to scale up manufacturing and support later stage clinical trials. This $5M Technology/Therapeutic Development Award is the latest example of the DoD’s ongoing commitment to invest in technologies to meet current and future health needs of our society.”

In addition to previous grant awards and non-dilutive funding from the National Institutes of Health, U.S. Department of Defense, State of Minnesota, AusIndustry, and other sources, this latest award from the Defense of Department brings the total amount of grants and non-dilutive funding to over $18.5M to support the advancement of SpineThera’s SX600 for epidural injection to treat lumbosacral radiculopathy.

About the Grant Award

The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work is supported by the Assistant Secretary of Defense for Health Affairs, through the Peer Reviewed Medical Research Program under Award No. W81XWH-21-1-0425. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. In conducting research using animals, the investigators adhere to the laws of the United States and regulations of the Department of Agriculture.

About SpineThera
SpineThera is a clinical stage pharmaceutical company working to improve the lives of patients by creating injectable drugs utilizing its micro-suspension platform technology.  SpineThera’s micro-suspension provides months long sustained-release of the active pharmaceutical ingredient with superior injectability at ultra-high concentrations.  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. The company’s lead investigational drug product, SX600, is a novel formulation of dexamethasone being developed for lumbar radiculopathy. SpineThera, Inc., is based in Medical Alley, Minnesota, the global epicenter of health innovation and care.

Press Contact
Jeff Missling | jmissling@spinethera.com

September 27, 2021

SpineThera Announces Addition of Vice President of Global Clinical Operations to Management Team

MEDICAL ALLEY, MINNESOTA, UNITED STATES, September 27, 2021 /EINPresswire.com/ -- SpineThera, Inc., a privately held, clinical stage pharmaceutical company focused on the development of SX600 (a novel formulation of sustained-release dexamethasone for treatment of sciatica) announced today that Vicki Gashwiler has joined the company as the Vice President of Global Clinical Operations.
July 26, 2021

SpineThera Announces Issuance of Fourth and Fifth Patents Covering its Sustained-Release Platform Technology

MEDICAL ALLEY, MINNESOTA, UNITED STATES, July 26, 2021 /EINPresswire.com/ -- SpineThera, Inc., a privately held, clinical stage pharmaceutical company focused on the development of SX600 (a novel formulation of sustained-release dexamethasone for treatment of sciatica) announced today that the United States Patent and Trademark Office (USPTO) has recently issued U.S. Patent Number 10,925,883 entitled Pharmaceutical Compositions and Uses Thereof. The issuance of the ‘883 patent will add to the company’s growing worldwide patent portfolio and is already issued in nineteen other countries. The issued claims of this patent family are directed at composition coverage of SpineThera’s novel biodegradable, sustained-release microsphere platform technologies. The company’s lead product, SX600, is currently being evaluated in a Phase 2 clinical trial for lumbar radiculopathy (sciatica) in Australia.
November 25, 2019

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.

Proven health impact

SpineThera produce more effective health-benefit leads, with a higher hit rate, in less time than any other method available today.