VIVEX Biologics has announced that the initial clinical trial results of the VAST Trial evaluating VIA Disc were published in The International Journal of Spine Surgery. The paper was the first-ever published 12-month results from Level 1 intradiscal study for treating patients with one or two level symptomatic degenerative disc disease (DDD), VIVEX said in a press release. VIA Disc is a non-surgical, injectable treatment option for patients suffering from chronic lower back pain resulting from DDD.
The paper, titled ‘VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease’, authored by Douglas Beall (Oklahoma City, USA) and colleagues, reported initial results from the 24-patient safety cohort of VIVEX’s VAST Trial evaluating the safety and performance of VIA Disc. Data demonstrate that VIA Disc improved pain and function in patients with DDD by greater than 70%, as measured by visual analogue scale (VAS) and Oswestry Disability Index (ODI), and that these improvements were durable one-year after the procedure.
“I am highly encouraged by the initial results and safety data from the VAST study. Implantation of disc tissue allograft can be done safely, and early evidence suggests greater than 70% improvements in VAS and ODI sustained at 12 months in the allograft groups,” said Beall. “Interventions like VIA Disc have the potential for treating mild-to-moderate degenerative discs that greatly advance an alternative to surgical intervention.”
Lower back pain is the most expensive occupational disorder in the USA and is the leading cause of disability globally. DDD is a major factor contributing to this disability and is the most common etiology of chronic lower back pain in adults. Low back and neck pain in the U.S. were the third-largest condition of spending in 2013, with estimated health care spending of $87.6 billion. Today, there are limited treatment options, including progression to opioids and surgery for patients who fail non-surgical management.
To address this gap in the continuum of care, VIVEX developed VIA Disc to offer patients a novel, non-surgical intervention for treating one to two levels of symptomatic DDD, the company’s press release adds.
Peter Wehrly, chief executive officer of VIVEX, stated: “The early evidence from the VAST study suggests VIA Disc is able to deliver meaningful and durable pain relief, restore function and improve quality of life. We look forward to continuing to build this important clinical body of evidence.”
The VAST Trial is a prospective, randomised, parallel-arm, multicentre study approved to enrol up to 220 subjects at up to 15 clinical sites. Outcomes of the trial were based on assessment of primary and secondary endpoints of six and 12 months after transplant of supplementary allograft compared with placebo or sustained conservative care in subjects who had discogenic pain attributable to disc degeneration as judged by magnetic resonance imaging scoring, physical examination and subject-reported pain.