The research, presented at the
In the analysis (poster number 44) of the double-blind, sham-controlled, Phase 3 study, patients with LDH were randomized to receive either a single intradiscal injection of SI-6603 1.25 Units or a sham injection, followed by 52 weeks of observation (Weeks 1, 2, 4, 6, 13, 26, 39, 52). The modified intention-to-treat (mITT) population included 341 participants (SI-6603 n=169; sham n=172). The study met its primary endpoint, showing significantly greater improvement vs. sham in worst leg pain at Week 13 (least squares mean [LSM] difference: -7.5; p=0.0263) with notable differences as early as Week 4 (-6.0; p=0.0418) and Week 6 (-7.4; p=0.0146).
Beginning at Week 1, more participants in the SI-6603 group vs. sham had a negative straight leg raise test (p=0.0054) which was sustained to Week 52 (p=0.0003). Notable differences in 50% responders for worst leg pain (i.e., meaning a 50% improvement from baseline) also favored SI-6603 vs. sham at Week 4 (p=0.0189), Week 6 (p=0.0297) and Week 13 (p=0.0165). There were no treatment-related serious adverse events with SI-6603.
'The early treatment response observed in this analysis is promising for those suffering from radicular leg pain resulting from lumbar disc herniation and who may experience severe, debilitating pain which can affect their mobility, and impact their ability to go about their usual activities. This is an area of significant unmet patient need and if approved, SI-6603, which targets the source of radicular leg pain, may help fill a current treatment gap between conservative pain management and surgery,' said
An analysis (poster number 171) of healthcare resource utilization and costs for patients with LDH who underwent LDH surgical procedures was also presented at ASPN 2024. Of the more than one million patients with LDH in the medical claims database, 58,328 underwent LDH surgeries within one year of initial diagnosis.
During the first year following initial diagnosis, patients treated with surgery had more LDH-related outpatient visits than non-surgery-treated patients (mean: 17.0 vs. 10.3) and a higher proportion of LDH-related hospitalizations (36.3% vs. 0.9%). Nearly half (48.2%) of surgery-treated patients received at least one epidural steroid injection (ESI) within the first year, with 49% of them receiving multiple ESIs. Total LDH-related healthcare cost during the first year was
About the Phase 3 Trial Data Analysis
In this double-blind, sham-controlled, parallel Phase 3 study - known as the Discovery 6603 clinical trial (NCT03607838) - participants were randomized 1:1 to receive either SI-6603 (1.25 U) or sham injection followed by 52 weeks of observation. The primary endpoint was defined as the change from baseline to Week 13 in average worst leg pain during the past 24 hours over the previous seven days, as assessed by Visual Analogue Scale, a pain rating score from 0 - 100 with a higher score indicating greater pain intensity. Key secondary endpoints included the change from baseline in average worst leg pain at 52 weeks, percentage of participants with negative straight leg raise test, and 50% responder rates for worst leg pain and Oswestry Disability Index. Endpoints were assessed using a mixed model for repeated measures analysis on the modified intention-to-treat population, which represented all randomized participants who received the study injection analyzed according to the assigned treatment. Missing data was handled using a mixed-effect model, without explicit imputation.
The trial included
About the Healthcare Utilization and LDH Surgery Analysis
For this study, investigators reviewed medical claims data from the IQVIA PharMetrics Plus database of 1,086,552 adults ages 30 to 70 years diagnosed with LDH
About Lumbar Disc Herniation
About 9 million adults in the
SI-6603, which contains condoliase as its active pharmaceutical ingredient, is an investigational product being studied for the treatment of radicular leg pain associated with lumbar disc herniation via a single, direct intradiscal injection. SI-6603 (condoliase) reduces nerve root compression and thereby pain.
SI-6603 was developed by
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