Vivex Biologics has announced the completion of subject enrollment in its ASCEND clinical trial, a pivotal study evaluating the safety and effectiveness of VIA Disc NP for the treatment of symptomatic degenerative disc disease (DDD).
The Miami (US) based company boasted that the milestone was reached ahead of schedule, with the trial now on track to deliver top-line results in the first quarter of 2026.
Chronic lower back pain caused by degenerative disc disease occurs when the cushioning discs between the vertebrae lose their water content and structural integrity, leading to pain, reduced mobility, and diminished quality of life. Current treatment options range from physical therapy and anti-inflammatory medications to opioids and invasive spinal surgeries, each carrying limitations, risks, or long-term consequences, including long-term dependence.
A Minimally Invasive Approach
VIA Disc NP is a minimally invasive, off-the-shelf, human nucleus pulposus tissue allograft. It is intended to supplement degenerated intervertebral discs and restore their cushioning function, helping to reduce pain and improve mobility. The therapy is administered as a single intradiscal injection, making it a potential alternative to more invasive procedures or long-term reliance on pain medications.
The ASCEND study is a randomized, double-blind, sham-controlled, multi-center Phase I/II trial (NCT06615505) conducted at five sites across Australia. It enrolled 110 participants who have suffered from chronic lumbar discogenic pain for more than six months and have not responded to at least three months of conservative therapy. Participants were randomized 1:1 to receive either the VIA Disc NP injection or a sham procedure.
The trial’s primary efficacy endpoint is the proportion of patients achieving a minimally clinically important difference (MCID) in their back pain score, defined as a 30% or greater reduction from baseline on the visual analogue scale (VAS) at six months post-procedure. The primary safety endpoint measures the proportion of participants experiencing treatment-related adverse events within 12 weeks.
A Second Major Trial Underway
In addition to ASCEND, Vivex is advancing another clinical study—the RESTORE trial (NCT06778447)—in the United States. This randomized, sham-controlled study will enroll up to 496 participants aged 22 to 85 across as many as 20 clinical sites. The trial features an initial open-label roll-in period, after which participants are randomized 2:1 to receive either VIA Disc NP or a sham procedure.
RESTORE’s primary efficacy endpoint mirrors that of ASCEND but extends the observation period to 12 months. Participants in the sham group who continue to experience symptoms after a year will have the opportunity to cross over and receive VIA Disc NP, followed by an additional year of follow-up. The study is expected to reach primary completion in May 2027.
With ASCEND enrollment complete, the focus now shifts to data collection and analysis. The trial’s results, expected in early 2026, will be critical in determining whether VIA Disc NP can move closer to broader adoption in the management of degenerative disc disease.
If successful, the therapy could offer a new standard of care for patients who have exhausted conservative treatments but are not ready, or willing, to undergo invasive surgery. Its potential to reduce reliance on opioid pain medication also aligns with ongoing public health efforts to address the opioid crisis.
