Immunomedics reports encouraging results for Sjogren's syndrome
Immunomedics has reported encouraging results from its Phase I/II trial with its compound, epratuzumab, for the treatment of Sjogren's syndrome, an autoimmune disease that currently affects between two to four million Americans.
Immunomedics has reported encouraging results from its Phase I/II trial with its compound, epratuzumab, for the treatment of Sjogren's syndrome, an autoimmune disease that currently affects between two to four million Americans.
Fifteen patients with primary Sjogren's syndrome were enrolled in this open-label, non-randomised, two-centre study to assess feasibility, safety, and early evidence of efficacy. Over an eight-week period, patients received 360 mg/m2 of epratuzumab every two weeks for a total of four doses. Fourteen patients received all four infusions without reactions with a median infusion time of fifty minutes. One patient discontinued the third infusion due to an acute infusion reaction, but completed the fourth infusion with no further reaction.
Patients reported improvements in their clinical signs and symptoms that include: dry eyes, dry mouth, fatigue, tender joints, tender points, tear and salivary flow. Specifically, twenty-four hours after the last treatment, symptomatic improvements ranging from 100% of patients experiencing tender joints to 33% of patients with salivary flow were observed. Moreover, when these patients were evaluated twelve weeks post therapy, 86% of patients who showed tender joints improvement retained clinical benefit, as did 20% of patients with increased salivary flow. A final evaluation is planned for six months after the last epratuzumab dose.
Evidence suggests that B-cells may play a key role in the inflammatory cascade of Sjogren's syndrome or lupus. Consistent with the company's past clinical experience with epratuzumab, the investigators also found a reduction of 50% to 60% in circulating B-cells in the patients enrolled in the trial. This data suggests that B-cell modulation may be the primary mechanism of action of epratuzumab, and that complete depletion of B-cells is not necessary to provide a clinical benefit.
'Current therapies for Sjogren's syndrome do not adequately treat the signs and symptoms, which is why these results are so encouraging,' commented Dr Ivan Horak, executive vice president, research and development, and cso of Immunomedics. 'Our first set of epratuzumab data demonstrates clinical improvement in this difficult-to-treat population of patients with Sjogren's syndrome. We intend to meet with the FDA shortly to discuss further development of epratuzumab in this indication.'
About Epratuzumab
Epratuzumab is a humanized monoclonal antibody that targets CD22 antigen, found on the surface of B-lymphocytes, a type of white blood cell. Epratuzumab is being evaluated in patients with Sjogren's syndrome and is also Immunomedics' lead product candidate in two pivotal Phase III trials for the treatment of patients with moderate and severe systemic lupus erythematosus (SLE). The FDA granted a Fast Track designation to the clinical development program for epratuzumab for the treatment of patients with SLE. Epratuzumab has also demonstrated good safety, tolerability, and clinical efficacy in more than 340 patients with non-Hodgkin's lymphoma, resulting in reports published in The Journal of Clinical Oncology and Clinical Cancer Research.
About Sjogren's Syndrome
Sjogren's syndrome is a chronic autoimmune syndrome characterised by lymphocyte infiltration of salivary glands resulting in symptomatic eye and mouth dryness. Sjogren's syndrome can be associated with extraglandular presentations such as musculoskeletal features including fatigue and fibromyalgia in nearly 50% of patients and fewer patients complain of arthralgias. According to the Sjogren's Syndrome Foundation, the condition affects approximately two million to four million Americans, mostly middle-age women.