Benzinga | Aug 11, 2021 04:01PM EDT

Equillium Offers Added Data From EQUALISE Type A Portion Of Study In Systemic Lupus Erythematosus Patients

Analysis of our Type A systemic lupus erythematosus patients without lupus nephritis that had elevated baseline urine protein/creatinine and albumin/creatinine ratios demonstrated a mean decrease of 42% and 53% respectively by Day 57 following two doses of Itolizumab

The Type B lupus nephritis cohort has been expanded to include newly diagnosed patients, in addition to refractory patients, and will evaluate a single subcutaneous dose level based on Type A PK/PD results

LA JOLLA, Calif.--(BUSINESS WIRE)-- Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced additional data from the EQUALISE Type A portion of the study in systemic lupus erythematosus (SLE) patients. The exploratory data set shows that patients without a diagnosis of lupus nephritis (LN) but with elevated urine protein/creatine ratio (UPCR) >200 mg/g (N=6, baseline geometric mean 378 mg/g)1 experienced a mean decrease from baseline in UPCR of 33% and 42% at Days 29 and 57 respectively, following subcutaneous doses of itolizumab on Days 1 and 15. Notably, one subject who had baseline UPCR of 1,505 mg/g declined to 974 mg/g at Day 29 and 857 mg/g by Day 57. Additionally, patients with elevated albumin/creatinine ratio (ACR) >30 mg/g (N=4, baseline geometric mean 97 mg/g)1 experienced a mean decrease from baseline in ACR of 22% and 53% at Days 29 and 57 respectively.

"We are intrigued by this observation from our Type A portion of the study in SLE patients who did not have a diagnosis of lupus nephritis and entered the study with elevated proteinuria, and experienced reductions in UPCR and ACR following two doses of itolizumab," said Dolca Thomas, executive vice president of research and development and chief medical officer of Equillium. "There is ongoing research in the field of rheumatology and nephrology that suggests patients who have elevated proteinuria with UPCR greater than 200 mg/g or ACR greater that 30 mg/g, which is below the typical diagnostic threshold for LN and other kidney diseases, may have subclinical disease - sometimes referred to as silent LN - where early intervention with a safe and active therapy may prevent more severe outcomes. We are continuing to analyze this exploratory data and look forward to initial results from active LN patients in the Type B portion of the EQUALISE study that is now enrolling."

Equillium is implementing an amendment to the Type B portion of the EQUALISE study in LN patients to include newly diagnosed patients in addition to refractory patients. The study will evaluate up to 20 patients dosed at 1.6 mg/kg subcutaneously bi-weekly for up to 24 weeks. The selection of the 1.6 mg/kg dose was based on the totality of the safety, tolerability, and PK/PD data in the Type A portion of the study that demonstrated a plateau in the reduction of CD6 cell surface expression above the 0.8 mg/kg dose; as previously reported itolizumab was safe and well tolerated through the 2.4 mg/kg dose level. Equillium expects to announce interim data from the Type B portion of the study by the end of the year. Equillium has received fast track designation from the FDA for itolizumab for the treatment of patients with lupus nephritis.

1 Missing data: UPCR on one patient at Day 57, ACR on two patients at Day 29