XBiotech has plans to advance its dermatology programme for its human antibody bermekimab with the commencement of a Phase IIb clinical study in patients suffering from moderate to severe hidradenitis suppurativa (HS).
The randomised, double-blind, placebo-controlled trial will analyse the safety and efficacy of bermekimab at different subcutaneous doses when compared with placebo.
It will also analyse the efficacy of bermekimab in HS and guide dosing strategies for the expected Phase III registration study.
The firm intends to enrol the first patient during the third quarter of 2019.
HS is a chronic, inflammatory skin disorder affecting areas rich in apocrine glands.
The Phase IIb study comes after two earlier clinical studies of bermekimab to treat HS.
XBiotech recently analysed bermekimab in a Phase II trial involving two groups of patients with HS.
These patients were those who had no prior treatment with biologics, while the other group was of those who had failed the only approved biological therapy to treat HS.
The trial was conducted at eleven research centres across the US. It indicated that bermekimab was similarly effective in HS patients irrespective of previous treatment with the current approved therapy.
Results of the study indicated that weekly treatment with bermekimab was related with statistically significant improvement in HS, as measured by the FDA-sanctioned Hidradenitis Suppurativa Clinical Response score (HiSCR).
The study showed that 61% of patients with no prior biological therapy achieved positive HiSCR at 12 weeks, while 63% of patients who had failed earlier biological therapy also achieved a positive HiSCR.
As HS is associated with severe pain, it was a key measure in the study.
At the study’s endpoint, patients with no previous biological therapy had a 64% reduction in pain compared with baseline, while those who had earlier failed anti-TNF therapy had a 54% reduction in pain. Only 43% of patients achieved HiSCR in its Phase III study that did not allow antibiotics and there was no great reduction in pain for Humira treated patients in the Phase III study.
XBiotech president and CEO, John Simard said: “We are extremely excited about the potential of bermekimab to treat inflammatory skin disease. We are eager to advance this programme in HS and to ultimately deliver a new treatment to patients suffering from this devastating disease.”