Equillium partner Biocon has commenced a Phase II clinical trial of itolizumab to treat ulcerative colitis (UC) patients.

The placebo-controlled, double-blinded trial will assess the safety and efficacy of itolizumab for subjects who are biologics-naïve with moderate to severe active UC.

These subjects will be categorised into a 1:1:1 ratio to receive 140mg itolizumab, adalimumab or placebo every two weeks for 12 weeks.

The trial will enrol up to 90 subjects at multiple trial sites in India. 

An anti-CD6 monoclonal antibody, itolizumab acts on the CD6-ALCAM pathway. 

This pathway has a key role in modulating effector T cells.

Under an exclusive collaboration with Biocon, Equillium gained rights to itolizumab.

Additionally, to develop and market itolizumab, Equillium has an exclusive option and asset purchase agreement in place with Ono Pharmaceutical earlier this month.

The rights include all treatment indications as well as those to market the therapy in the US, Australia, Canada and New Zealand.

Biocon managing director and CEO Siddharth Mittal said: “We are encouraged by the progress being made on our high-value, multi-indication molecule, itolizumab, in collaboration with Equillium. 

“The commencement of the Phase II clinical study, that will provide data related to its efficacy as a treatment of ulcerative colitis, is an important step forward in our efforts to bring the potential benefit of itolizumab to patients in India suffering from this disease. 

“The development also underpins Biocon’s commitment to bring innovative, affordable medicines, that address unmet patient needs, to market expeditiously.”

According to data from the Phase Ib EQUATE trial of itolizumab in severe acute graft-versus-host disease, the therapy offered meaningful complete responses, especially in people with lower gastroenterological symptoms.