Clinical Trials Arena

Further data presented from UCB’s Phase III studies of bimekizumab

The most recent data adds to the initial announcement that the candidate met primary and secondary endpoints in the Phase III studies.

Further data from UCB’s two Phase III studies shows bimekizumab has demonstrated "clinically meaningful improvement" for patients with moderate-to-severe hidradenitis suppurativa (HS).

The first analyses of pooled data from the two Phase III bimekizumab studies (BE HEARD I and BE HEARD II) reports that bimekizumab-treated patients showed higher response rates in the primary endpoint (HiSCR50) at Week 16 vs. placebo (58% Q2W/Q2W, 55.9% Q2W/Q4W, 56.1% Q4W/Q4W vs. 33.4% for placebo).

Study meets primary and secondary endpoints

In December 2022, the company reported initial data revealing that the trials had met primary and secondary endpoints.

Head of the US UCB, Emmanuel Caeymaex, said: “Patients with HS live with one of the most burdensome chronic systemic skin diseases. There is a compelling need for new treatment options that can offer high and durable clinical response.”

The BE HEARD I and II studies (NCT04242446 and NCT04242498) included an initial 16-week period before a 32-week treatment period. There were a total of 1,014 adult patients, who were randomised to four arms.

GlobalData forecasts global sales for bimekizumab of $2.59bn in 2029. GlobalData is the parent company of the Clinical Trials Arena.

Trial results showed improved responses in all groups

Bimekizumab-treated patients had improved responses at week 48 with approximately six in ten patients achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75). More than eight out of ten patients who achieved Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at week 16 maintained the response through week 48.

There was a numerically higher patient response in bimekizumab patients vs. placebo at week 16 at Hidradenitis Suppurativa Clinical Response 100 (HiSCR100). At week 48, approximately three out of ten patients achieved HiSCR100.

The safety profile of bimekizumab remained consistent with previous studies with no new safety concerns observed.

The safety and efficacy of bimekizumab in HS have not been established, and it is not approved for use in HS by any regulatory authority worldwide. In the US, the efficacy and safety of bimekizumab have not been established for any indication and it is not approved by the US Food and Drug Administration.