Cimziatin (certolizumab pegol) is the world's first PEGylated, Fc-free anti-tumour necrosis factor (TNF). Unlike other anti-TNF drugs currently available, its Fc-free nature means that it avoids potential cellular cytotoxicity, said its developers, UCB. Incidentally, UCB is also developing cimziatin for indications in Crohn's disease and rheumatoid arthritis.
The first study involving patients treated with the investigational drug demonstrated that subcutaneous regimens of both the 200mg and 400mg liquid formulations significantly reduced the redness, thickness and scaliness of psoriasis lesions compared with placebo, according to data shown to attendees of the European Academy of Dermatology and Venereology (EADV) Annual Meeting.
"The results… suggest that it has the potential for further development into a valuable new treatment option for this difficult-to-treat disease," said Professor Jean-Paul Ortonne, Department of Dermatology, Hospital Larchet, Nice, France.
During the Phase II, randomised, double-blind placebo-controlled dose-ranging study, the drug was given every fortnight over a period of 12 weeks to 176 patients with moderate to severe chronic plaque psoriasis, 60 (34 per cent) of who had previously been treated with other biologics (including 41 with other anti-TNFs).
In the sub-group of patients treated with a prior biologic (either anti-TNF or T-cell modulator), the difference in Psoriasis Area and Severity Index (PASI) 75 response (the 'gold standard' for the assessment of extensive psoriasis) between the active and placebo groups was 80 per cent and 86 per cent in the 200mg and 400mg arms respectively (p<0.001). Similar results were observed in the further subgroup of patients who had just received prior anti-TNF therapy.
"These results suggest that patients with moderate to severe psoriasis treated with cimziatin may achieve high levels of response, irrespective of prior biologic use," remarked Olav Hellebo, senior vice president and president of Inflammation Operations, UCB.
Meanwhile, 66.7 per cent of patients in the cimziatin 200mg arm and 61.4 per cent of patients in the 400mg arm reported an adverse event, the majority of which were of mild or moderate intensity, compared to 67.2 per cent of patients in the placebo arm, said UCB. All the study participants are currently being followed-up until relapse or for a maximum of 24 weeks.
Psoriasis is a chronic skin disease of scaling and inflammation that affects around 125m people worldwide, mainly adults, including 2 per cent of the European population (one in 50 people). It is often hard to get rid of and recurrences are common so new drugs that can more effectively treat the condition are required.
Current treatments include drugs that target the pathophysiological effects of TNF-alpha, which is a cytokine that plays a key role in mediating pathological inflammation, and when produced in excess in the body, is implicated in a wide variety of diseases, including psoriasis.
UCB is not alone in its quest to develop a new treatment for this skin ailment. Earlier this month Abbott has announced it is "very excited" with its novel psoriasis treatment, from results in Phase II trials.
According to Abbott, the drug ABT-874 stands apart from other biologic drugs that treat psoriasis because it is the first treatment to target a part of the inflammatory response not addressed in other therapies.
While other drugs, such as the currently available Humira (adalimumab), as well as UCB's cimziatin, bind to TNF-alpha, Abbott's investigational compound ABT-874, a fully human monoclonal antibody, is touted as having a novel mechanism whereby it targets and neutralises interleukin-12 and interleukin-23, two proteins involved in the inflammatory response.
According to the firm, nine out of 10 patients with moderate to severe psoriasis in four of five dosing groups achieved 75 per cent improvement in symptoms after 12 weeks. This was compared to three per cent improvement of patients that received the placebo.
In addition, more than half of the 180 patients that took part in the trial achieved a 90 per cent improvement, the firm reported.
"It's the best clearance results than anything we have seen out there to date," Abbott spokeswoman Tracy Sorrentino told BioPharma-Reporter.com in an earlier interview.