Equillium’s anti-CD6 monoclonal antibody itolizumab has shown promise in a late-stage study evaluating the drug as a treatment for graft versus host disease (GvHD).
The biotech announced a positive recommendation from an Independent Data Monitoring Committee (IDMC) based on its review of interim results from the phase 3 EQUATOR study.
The trial has been investigating the safety and efficacy of the candidate, administered intravenously, alongside standard care high-dose corticosteroids as a first-line therapy for adults and adolescents with acute cases of the condition.
Equillium outlined that the IDMC reviewed unblinded data on over 100 patients through day 29 of treatment and recommended that the study proceed with continued enrolment without any changes.
Approximately one-third of the 1,200 patients who undergo a donor stem cell or bone marrow transplant each year in England will develop GvHD, which occurs when white blood cells in the donated tissue begin to attack the recipient’s organs and weaken their immune system.
The condition typically affects patients within the first year after a transplant and is usually mild, but can be fatal in 10% of cases.
Itolizumab is designed to selectively target the CD6-ALCAM signalling pathway, which plays a key role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases.
Equillium’s chief executive officer, Bruce Steel, said: “We have over 100 clinical sites worldwide enrolling patients and look forward to completing the study expeditiously.
“We believe that itolizumab may demonstrate a significant benefit for patients suffering from acute GvHD, where mortality rates are very high and first-line standard of care remains high-dose corticosteroids.”
The interim data and IDMC recommendation have been delivered to Ono Pharmaceutical, which has until the end of October to exercise its option to acquire Equillium’s rights to itolizumab for approximately $35m.
The announcement comes just two months after Equillium shared positive top-line results from a phase 2 study of its multi-cytokine inhibitor EQ101 in adults with moderate, severe or very severe alopecia areata.
Results demonstrated a favourable safety and tolerability profile with no serious adverse events, and improvements in SALT scores were above the published historically low placebo response rates.