Israel-based XTL Biopharmaceuticals, a clinical stage biotech company that focuses on the development of new drugs for the treatment of autoimmune diseases, has announced that its lead drug candidate, hCDR1, has been granted a patent by the Hungarian Intellectual Property Office.
The patent, “Synthetic Human Peptides and Pharmaceutical Compositions Comprising Them for the Treatment of Systemic Lupus Erythematosus,” joins a series of other patents granted for the drug in other major European markets as well as the U.S., Canada, Korea, Japan, and China.
The drug hCDR1 (Edratide), a novel synthetic peptide compound based on the complementarity-determining region 1 (CDR1) of a human anti-DNA monoclonal antibody (mAb), leads to a series of molecular events that culminate with the downregulation of SLE-associated autoreactive immune cells (T- and B-cells).
The company has gathered clinical efficacy and safety data on the drug compound in three clinical trials that included more than 400 patients and also preclinical data from more than 200 preclinical studies. Some of these results have been published and show that hCDR1 is safe and well tolerated. This treatment has also shown encouraging efficacy results, with significant effects in some clinically meaningful endpoints.
“About one out of every 750 women in Europe has systemic lupus erythematosus (SLE), with virtually no effective treatment options. We look forward to advancing our clinical program for hCDR1, which we believe holds promise to benefit this patient population,” Josh Levine, CEO of XTL, said in a press release. “As we head into our global Phase 2 trial in the U.S. and the EU, we benefit from our IP position and from our Small or Medium Sized Business Enterprise (SME) status which the European Medicines Agency (EMA) recently granted to our Company.”
The company expects to begin a new Phase 2 trial this year.
Aurinia Pharmaceuticals recently announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to voclosporin, a next-generation calcineurin inhibitor under development to treat patients with lupus nephritis (LN) and other autoimmune diseases.
LN is a kidney inflammation caused by systemic lupus erythematosus (SLE) in which patients may develop proteinuria, hematuria, and a decrease of renal function.