XTL Biopharmaceuticals announced that a patent has been issued covering the Europe Union for its leading drug candidate, hCDR1 (edratide), a potential treatment for systemic lupus erythematosus (SLE).
The European Patent Office issue (EP1594434) is titled “Parenteral Formulations of Peptides for the Treatment of Systemic Lupus Erythematosus,” and covers formulations of hCDR1 and the use of these pharmaceutical compositions in the treatment of SLE.
hCDR1 is designed to ameliorate the SLE-related autoimmune process by specific upstream immunomodulation through the generation of regulatory T-cells, the company said on its website. These T-cells initiate a series of molecular events involving beneficial effects on autoreactive T- and B-cells, autoantibodies and various pathogenic cytokines and immunosuppressive molecules, which are thought to restore immune balance.
In three clinical studies generating data on more than 400 patients, the drug has shown a favorable safety profile, was well-tolerated and demonstrated efficacy in at least one clinically meaningful objective.
“This important patent in Europe augments the robust intellectual property position we are building globally. hCDR1 has been granted patents in markets including the U.S., Canada, Australia, Korea, Japan, India, and China,” Josh Levine, XTL’s chief executive officer, said in a press release. “Europe is one of the largest markets in the world for SLE, with few effective treatment options available. Through our upcoming Phase 2 trial, we look forward to developing hCDR1 as a potential treatment to serve this unmet need.”
The drug received a patent by the Hungarian Intellectual Property Office in March, the company previously announced.
According to the Lupus Foundation of America, an estimated 1.5 million Americans have lupus, and 5 million people worldwide. Most are women in their childbearing years. New treatments for SLE are a priority, since only one drug has been approved by the U.S. Food and Drug Administration (FDA) in the past 50 years, Benlysta (belimumab), approved in 2011.
A scientific article reporting favorable results of a Phase 2 study (NCT00203151) of hCDR1 in lupus patients, “Safety and efficacy of hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study,” was published in 2015 in the journal Lupus Science and Medicine.