UCB announced 48-week post-hoc analyses of pooled Phase 3 data from the BE HEARD I and BE HEARD II studies examining the impact of BIMZELX on skin pain and draining tunnels in adults with moderate-to-severe hidradenitis suppurativa (HS). These results are shared at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California, March 8?12. Analyses showed that BIMZELX-treated patients reported clinically meaningful improvements in skin pain up to 48 weeks across various assessed outcomes, including the HS Symptom Questionnaire (HSSQ) skin pain item, the Patient Global Impression of Severity of Skin Pain (PGI-S-SP) and the Change in Severity of Skin Pain (PGI-C-SP).

Additionally, patients demonstrated greater reductions in draining tunnel count compared to those on placebo at Week 16. Responses were either sustained or improved to Week 48. BIMZELX is not currently approved for the treatment of moderate-to-severe HS by any regulatory authority worldwide.

The efficacy and safety profile of BIMZELX in the treatment of moderate-to-severe HS have not been established and this is an investigational indication only. At baseline, adult patients (N=1,014) were randomized 2:2:2:1 (initial/maintenance) to receive, either BIMZELX 320 mg every two weeks Q2W/Q2W (n=288), BIMZELX Q2W/Q4W (n=292), BIMZELX Q4W/Q4W (n=288) or placebo/BIMZELX Q2W (n=146). Across treatment groups, the mean baseline HSSQ skin pain score was 5.8 (on a scale of 0-10, with higher score indicating more pain).

At baseline, 72.8% of patients had draining tunnels with the count comparable across regimens (mean range 3.3?3.8). Highlights of the BIMZELX data in moderate-to-severe HS presented at AAD 2024: Impact on pain: At Week 48, HSSQ skin pain response was achieved by 64.6?75.7% of patients. At Week 48, HSSQ skin pain score of 0 was achieved by 12.7?19.8% of patients.

From Weeks 0?48, HSSQ skin pain scores reduced by 36.9?43.7% across treatment groups. At Week 48, 55.9?63.7% of patients rated their skin pain "much better" using the PGI-C-SP. At Week 48, 3.9?7.8% rated PGI-S-SP "severe" vs.

28.5-33.3% at baseline and 45.6?47.4 rated PGI-S-SP "mild" vs. 15.1?16.7% at baseline. Impact on draining tunnel count: At Week 16, the draining tunnel percent change from baseline (CfB) was higher with BIMZELX vs.

placebo (-43.9 to -45.7 vs. -21.5%). BIMZELX-treated patients also saw greater absolute changes in draining tunnel count vs.

placebo. The percentage and absolute CfB increased through Week 48 across all BIMZELX groups. At Week 16, greater proportions of BIMZELX-treated patients saw draining tunnel reductions of three or more vs.

those on placebo (58.0?70.6 vs. 35.0%), with responses sustained or improved to Week 48 across regimens (79.4?88.7%).