SpineThera, Inc., a privately held, clinical-stage pharmaceutical company focused on the development of SX600 (a novel formulation of extended-release dexamethasone microspheres for transforaminal epidural injection [TF-EI] for the management of sciatica pain) today announced promising results from its Phase 2 proof-of-concept trial, SALIENT, supporting advancing the SX600 clinical development program and the potential for SX600 to represent a meaningful advance in the management of radicular leg pain (sciatica).

• Clinically meaningful effectiveness was demonstrated for SX600 compared with placebo
  • 71% of patients who received SX600 25 mg had ≥ 50% improvement from baseline in worst daily leg pain (WDLP) compared with 13% of patients who received placebo at 60 days (the primary endpoint and assessment time), representing a large magnitude of effect
• Importantly, this effect was durable after a single TF-EI
  • SX600 25 mg was associated with lasting, clinically relevant pain relief in a high proportion of patients, with ≥ 64% of patients who received SX600 25 mg experiencing ≥ 50% improvement in their WDLP from baseline from Day 30 through Day 180
• Improvements in pain relief were associated with meaningful improvements in function (Oswestry Disability Index), quality of life (QOL, SF-36), patient perceived efficacy, and reduction in the use of rescue pain medication
• Dexamethasone exposure was consistent with nonclinical data and clearly represents an extended-release drug profile with plasma dexamethasone detected through 90 days following a single TF-EI
• The overall safety profile was favorable and generally comparable with placebo

The SALIENT trial was a randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of SX600 administered by TF-EI to patients with unilateral radicular leg pain secondary to lumbar disc herniation. In total, 56 patients were randomized (17 [SX600 25 mg] 21 [SX600 12.5 mg], 18 [placebo]). The primary endpoint was the proportion of patients with ≥ 50% improvement in mean WDLP at 60 days post dosing. This magnitude of pain reduction is considered substantial by the IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) group as well as clinically relevant for patients with sciatica.^1,2 Patients were evaluated for analgesic efficacy, patient-reported measures of disability, QOL, and perceived efficacy, and safety through 180 days after dosing.

“SX600 has the potential to be a truly meaningful improvement in how we manage our patients suffering with radicular leg pain and the associated functional disability. The extended duration of effect, coupled with associated improvements in both disability and QOL, and favorable safety profile support the potential for SX600 to be a best-in-class therapy and strong, non-opioid addition to our armamentarium to combat this common, painful condition,” said Dr. Guy Ludbrook, Professor of Anesthesia at the Royal Adelaide Hospital, Head of Acute Care Medicine at the University of Adelaide, Director of PARC Clinical Research, and Principal Investigator in the SALIENT trial.

“In this Proof-of-Concept study with very strict entry criteria, we have demonstrated very encouraging results that represent clinically meaningful effectiveness associated with a large effect size despite relatively modest patient numbers. The fact that more than two-thirds of patients who received SX600 25-mg had a ≥ 50% improvement in their radicular leg pain at every timepoint from Day 30 through Day 180 represents SX600 to truly be an extended duration therapy option for patients with sciatica,” said Dr. Bill Houghton, SpineThera’s former Chief Medical Officer and Medical Director for the SALIENT trial.

“We are delighted with these exciting results and very appreciative of the SpineThera team and SALIENT trial Investigators passion and hard work. These results mark a key milestone for SpineThera, and we look forward to entering the next stage in development for this promising asset,” said Jeff Missling, CEO and Board Chairman.

About SpineThera

SpineThera is a clinical stage pharmaceutical company working to improve the lives of patients by creating injectable drugs utilizing its patented 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 the management of sciatica pain. SX600, dexamethasone acetate microspheres for micro-suspension injection, was designed as a targeted, extended-release corticosteroid with the potential to demonstrate a substantially improved benefit-risk profile relative to current epidural steroid injections for radicular leg pain. SpineThera, Inc., is based in Medical Alley, Minnesota, the global epicenter of health innovation and care.

References

1. Giraudeau B, Rozenberg S, Valat JP. Assessment of the clinically relevant change in pain for patients with sciatica. Ann Rheum Dis. 2004;63(9):1180-1.

2. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21.

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