Ferring Pharmaceuticals and Seikagaku Corporation announced the presentation of data looking at the efficacy and safety profile of SI-6603 (generic name: condoliase), an investigational product intended to treat radicular leg pain associated with lumbar disc herniation (LDH). The research, presented at the American Society of Interventional Pain Physicians (ASIPP) Annual Meeting, included a registrational Phase 3 trial and an integrated safety analysis of six clinical studies, as well as a real-world analysis of current treatment options and gaps in clinical management of patients with newly-diagnosed LDH. The registrational Phase 3 trial was a double-blind, sham-controlled, parallel study in which patients (n=352) with LDH were randomized to receive either a single intradiscal injection of SI-6603 1.25 Units or a sham injection.

The study met its primary endpoint, with participants in the SI-6603 treatment group showing significantly greater improvement in worst leg pain score vs. the sham group at Week 13 following treatment (least squares mean [LSM] change from baseline of -41.7 vs. -34.2; p=0.0263).

Overall, 71.9% of participants in the SI-6603 group experienced at least one treatment-emergent adverse event (TEAE) vs. 60.3% in the sham group, of which 28.1% and 10.3%, respectively, were considered treatment related. No treatment-related serious adverse events (SAE) occurred.

The integrated safety analysis of data from completed Phase 2 and 3 clinical trials for SI-6603 found that up to Week 13, TEAEs were reported in 65.9% patients treated with SI-6603 1.25 U and 54.3% who received sham or placebo, of which 25.8% versus 13.1%, respectively, were considered treatment-related. Most TEAEs were considered mild to moderate in severity. At Week 13, the incidence of SAEs was similar for both groups (2.6% vs.

3.3%, respectively), and only one SAE (back pain) was considered related to SI-6603.