New data from a phase II trial of Boehringer Ingelheim’s psoriasis candidate BI 655066 back up earlier results showing it is more effective than a rival drug from Johnson & Johnson.
After nine months’ treatment, 69% of moderate-to-severe plaque patients treated with the highest dose (180mg) of Boehringer’s interleukin-23 inhibitor had clear or almost clear skin, compared to 30% of patients treated with J&J’s Stelara (ustekinumab), which blocks both IL-12 and IL-23.
Patients on BI 855066 also achieved this level of skin clearance in around eight weeks – around half the time recorded for Stelara, and the response lasted for around two months longer (32 weeks versus 24 weeks), according to the company.
“Achieving clear skin quickly and maintaining clearance is an important goal for patients that have to deal with the daily impact of psoriasis,” said the study’s lead investigator, Kim Papp of Canada’s Probity Medical Research.
Boehringer also reported updated phase II results – originally released in March which showed that after 12 weeks of treatment, BI 655066 achieved nearly-clear skin in 81% of patients, compared to 30% of the Stelara group. At the time, Papp said that the study suggested Stelara’s IL-12 activity was making little or no contribution to the drug’s efficacy.
Stelara achieved sales of $1.3bn last year as a better-tolerated alternative to tumour necrosis factor (TNF) inhibitors in psoriasis therapy, but looks set to come under significant pressure from new drugs which have shown superior efficacy in trials.
That list includes Novartis’ IL-17 inhibitor Cosentyx (secukinumab), recently approved for psoriasis in US, Europe and Japan, and AstraZeneca’s brodalumab which hits the same target.
Meanwhile, the market for non-TNF-based therapies for psoriasis looks set to get increasingly crowded, with two other IL-23 inhibitors – J&J’s guselkumab and Merck & Co/Sun Pharma tildrakizumab – both reporting phase II clinical data in the last few months, and Lilly’s anti-IL-17 drug ixekizumab also progressing through late-stage testing.