Equillium's itolizumab promising in phase 3 graft versus host disease study

Equillium recently announced encouraging outcomes from a late-stage trial evaluating itolizumab, its anti-CD6 monoclonal antibody, as a treatment for graft versus host disease (GvHD). This development follows a positive recommendation from an Independent Data Monitoring Committee (IDMC) after reviewing interim results from the phase 3 EQUATOR study.

The EQUATOR trial has been examining the safety and efficacy of itolizumab, administered intravenously alongside standard high-dose corticosteroids, as a first-line therapy for adults and adolescents experiencing acute GvHD. The IDMC reviewed unblinded data from over 100 patients through the first 29 days of treatment and recommended the continuation of the study without any modifications.

GvHD is a condition that affects about one-third of the 1,200 patients undergoing donor stem cell or bone marrow transplants annually in England. It occurs when the white blood cells in the donated tissue attack the recipient’s organs, thereby weakening their immune system. The condition typically manifests within the first year post-transplant and, while usually mild, can be fatal in around 10% of cases.

Itolizumab works by targeting the CD6-ALCAM signaling pathway. This pathway is crucial in regulating the activity and movement of T cells, which are implicated in various immuno-inflammatory diseases. Bruce Steel, Equillium's CEO, expressed optimism about the potential of itolizumab to significantly benefit patients with acute GvHD, particularly given the high mortality rates and the standard reliance on high-dose corticosteroids as the first-line treatment.

“We have over 100 clinical sites worldwide enrolling patients and look forward to completing the study expeditiously,” said Steel. He emphasized the potential of itolizumab to provide substantial benefits to patients dealing with acute GvHD.

The interim data and the IDMC's recommendation have been forwarded to Ono Pharmaceutical. Ono has until the end of October to decide whether to exercise its option to acquire Equillium’s rights to itolizumab for approximately $35 million.

In addition to the progress with itolizumab, Equillium recently shared positive top-line results from a phase 2 study of its multi-cytokine inhibitor, EQ101, in adults with moderate to severe alopecia areata. These results, announced just two months earlier, indicated a favorable safety and tolerability profile with no serious adverse events. Furthermore, improvements in SALT scores, a measure of hair loss severity, were significantly better than historically low placebo response rates.

The continued development and promising results of itolizumab highlight Equillium's commitment to addressing severe immuno-inflammatory conditions. With the potential acquisition by Ono Pharmaceutical on the horizon, the biotech company is poised for significant advancements in its treatment offerings for GvHD and other related diseases.