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.
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Contacts
Jeff Missling | jmissling@spinethera.com
