Equillium’s add-on lupus treatment improved a biomarker of kidney function in an unblinded phase 1 study, setting the ball rolling toward Ono Pharmaceuticals’ court for future development work.
Itolizumab helped reduce patients’ urine protein creatinine ratio (UPCR) when tacked onto steroids and immunosuppressants mycophenolate mofetil or mycophenolic acid, Equillium reported Monday. The company reported that six out of 16 evaluable patients with lupus nephritis in the trial’s type B portion had a complete response through week 36, defined as a greater than 50% reduction in UPCR and a ratio lower than 0.7 g/g. Elevated UPCR levels can be indicative of kidney dysfunction.
Equillium didn’t directly spell out what the overall response rate was among treated patients but said it was comparable to Aurinia Pharmaceuticals’ approved lupus treatment Lupkynis, which notched a 70% ORR at the six and 12-month mark in a phase 3 study.
The most common side effects in Equillium’s study were a lack of white blood cells called lymphocytes and leg swelling. Two patients reported at least one serious side effect but neither were related to itolizumab.
“These itolizumab results occurred in the setting of patients tapering their systemic corticosteroids, maintaining stable kidney function, or eGFR, and increasing serum albumin while on study,” Chief Medical Officer Maple Fung said in a release.
The question now is whether or not Ono, Equilliam’s itolizumab partner, will opt-in to further development. Equillium described the data as the first of two readouts that Ono can use to make its decision. A firm answer is expected in the second half of the year.
Lupus is the third of three indications Equillium is aiming itolizumab at, following acute graft-versus-host disease and ulcerative colitis. The latter is being studied in a clinical trial in India sponsored by Biocon. Phase 3 results in patients with graft-versus-host disease are expected in the third quarter, the second readout informing Ono’s opt-in decision.
Beyond itolizumab, Equillium will soon report data on midstage alopecia asset EQ101 in the second quarter. The company maintains full worldwide rights to the drug.