XTL Biopharmaceuticals Unveils Expanded hCDR1 Preclinical Data for the Treatment of Sjögren’s Syndrome

  • Additional data shows a statistically significant effect in the gene expression of two additional genes that have a role in the pathogenesis of Sjögren's syndrome (SS) 
  • Substantial unmet medical need in estimated four million U.S. patients 
  • Filed patent covers the effect of hCRD1 on such gene expression with implications for the treatment of SS  

RAANANA, Israel I April 5, 2017 I XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company developing treatments for autoimmune diseases, today announced the Company has received additional preclinical data regarding the role of hCDR1 as a potential treatment for Sjögren's syndrome (SS) from Prof. Edna Mozes of The Weizmann Institute of Science and the developer of hCDR1.  

The expansion of these in-vitro data includes peripheral blood mononuclear cells (PBMC) obtained from additional blood samples from patients with primary SS. The data to date show that incubation with hCDR1 results in a statistically significant reduction in the gene expression of four pathogenic cytokines known to be involved in SS and lupus (including B-lymphocyte stimulator or BLyS), as well as upregulation of an immunosuppressive gene and a marker for activity of regulatory T cells. Such effects were previously seen in similar studies involving lupus patients. Concurrently, hCDR1 is in development for the treatment of systemic lupus erythematosus (SLE), has been tested in over 400 patients, and is ready to enter a global Phase 2 trial for SLE.

"We are pleased by the results of this extension study, which reinforce the potential of hCDR1 to provide patients with Sjögren's syndrome with the first-ever approved therapy to treat the systemic manifestations of the disease," said Josh Levine, CEO of XTL. "Given Sjögren's syndrome and systemic lupus erythematosus may have similar but distinct disease manifestations, these data further support the positive results of our prior Phase 2 study of hCDR1 in treating SLE. Both SLE/lupus and SS have large unmet clinical needs, with few satisfactory treatment options and both indications have seen recent failures in clinical studies with the notable exception of the recent successful Phase 2 in Lupus Nephritis of Voclosporin being developed by Aurinia Pharmaceuticals."

Based on hCDR1's well-known mechanism of action and favorable safety profile, XTL plans to pursue an accelerated clinical development path for the treatment of SS. Additionally, a second patent application has been filed with the U.S. Patent and Trademark Office for hCDR1 in the treatment of SS.

About Sjögren's syndrome 

Sjögren's syndrome is a systemic autoimmune disease with some autoantibodies and clinical manifestations similar to those detected in SLE. Although many patients experience dry eyes, dry mouth, fatigue and joint pain, Sjögren's syndrome may also cause dysfunction of organs such as the kidneys, gastrointestinal system, blood vessels, lungs, liver, pancreas, and the central nervous system. Patients also have a substantially higher risk of developing lymphoma. Today, as many as four million Americans are living with this disease, according to the Sjögren's Syndrome Foundation.

Current standard of care in the U.S. includes treating specific symptoms such as dry eyes, dry mouth, and arthritis. Systemic manifestations are often treated with drugs used to treat other autoimmune diseases, such as hydroxychloroquine, methotrexate, or azathioprine. However, these treatments are not sufficient in many patients and may have significant side effects. There is no approved specific drug for the treatment of systemic manifestations in Sjögren's syndrome.

About hCDR1 

hCDR1 is a novel compound with a unique mechanism of action and clinical data on over 400 patients in three clinical studies. The drug has a favorable safety profile, is well tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint. For more information please see a peer reviewed article in Lupus Science and Medicine journal (full article).

About XTL Biopharmaceuticals Ltd. (XTL) 

XTL Biopharmaceuticals Ltd., is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune diseases. The Company's lead drug candidate, hCDR1, is a world-class clinical asset for the treatment of autoimmune diseases including systemic lupus erythematosus (SLE) and Sjögren's Syndrome (SS). The few treatments currently on the market for these diseases are not effective enough for many patients and some have significant side effects. hCDR1 has robust clinical data in three clinical trials with 400 patients and over 200 preclinical studies with data published in more than 40 peer reviewed scientific journals.

XTL is traded on the Nasdaq Capital Market (XTLB) and the Tel Aviv Stock Exchange (XTLB.TA). XTL shares are included in the following indices: Tel-Aviv Biomed, Tel-Aviv MidCap, and Tel-Aviv Tech Index.

SOURCE: XTL Biopharmaceuticals

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