VERTANICAL Achieves Significant Milestone in Chronic Low Back Pain Treatment with VER-01 Results

VERTANICAL's Breakthrough in Chronic Low Back Pain Treatment

Overview of VER-01 Findings

VERTANICAL recently announced the successful outcome of its Phase 3 trials for VER-01, a new treatment for chronic low back pain (CLBP). Published in the influential journals Nature Medicine and Pain Therapy, these studies demonstrate VER-01's ability to significantly reduce pain intensity compared to a placebo, with effects sustained over a 12-month period. This could mark a potentially groundbreaking advancement in pain management, as chronic low back pain affects over 500 million people globally and is a leading cause of disability.

Clinical Trial Details

The results from two Phase 3 studies provide compelling evidence of VER-01's efficacy. In a placebo-controlled trial involving 820 patients, those treated with VER-01 reported an average reduction of 1.9 points on a 10-point scale for pain relief after just 12 weeks of treatment. This improvement increased to an impressive 2.9 points after six months, indicating sustained relief. The study found that participants also experienced significant improvements in sleep quality and physical function, aspects frequently compromised by chronic pain.

Moreover, VER-01 was well tolerated by patients, showing no signs of dependence or withdrawal symptoms. Adverse reactions, primarily mild to moderate, were generally transient and occurred mainly during the initial phase of the treatment.

ELEVATE Study - Comparing VER-01 and Opioids

In a parallel study named ELEVATE, VER-01 was compared directly with standard opioid treatments. This study, which enrolled 384 participants, reaffirmed VER-01’s superiority not only in pain relief but also in gastrointestinal tolerability. Patients on opioids faced a significantly higher incidence of constipation, while those on VER-01 were four times less likely to experience this issue. Crucially, VER-01 provided effective pain relief without the severe side effects commonly associated with opioids, including addiction risks.

Prof. Roger Knaggs, President of the British Pain Society, highlighted that the two Phase 3 studies position VER-01 as a potentially transformative therapy for chronic pain management.

The Future of VER-01

Following these promising results, VERTANICAL has applied for marketing authorization for VER-01 across several European markets. Furthermore, they plan to initiate a Phase 3 study in the United States in early 2026 to support an FDA submission. If approved, VER-01 could become a revolutionary treatment option for chronic back pain patients worldwide.

About VERTANICAL

Founded in 2007, VERTANICAL is focused on developing innovative therapeutic solutions for chronic pain. With its headquarters in Munich, Germany, VERTANICAL is recognized for its advanced biopharmaceutical development practices and extensive clinical research program.

In conclusion, the trial results underscore a crucial shift in chronic pain treatment paradigms. By offering an alternative to both over-the-counter analgesics and opioids, VER-01 could vastly improve patient quality of life and address the significant challenges posed by current therapies. The results bring hope to countless individuals who suffer from chronic low back pain, awaiting effective and safer treatment alternatives.