A therapy that XTL Biopharmaceuticals is developing for autoimmune diseases significantly reduced the expression of several cell signaling molecules called cytokines that play a role in the development of Sjögren’s syndrome (SS) associated with lupus, the company reported.
The news came in a press release updating XTL’s efforts to develop hCDR1 for systemic lupus erythematosus (SLE), SS, and other autoimmune diseases.
The company said in vitro, or lab-derived, data showed that hCDR1 lowered the expression of several of the cytokines linked to SS, an immune system disorder that causes dry eyes and a dry mouth. Sjogren’s syndrome often accompanies other immune system disorders, like SLE.
XTL also reported the completion of the design of a Phase 2 clinical trial investigating hCDR1 as an SLE treatment. The international study will begin after the company applies for investigational new drug (IND) status with the U.S. Federal Drug Administration.
The trial design includes a dose of 0.5 mg hCDR1 a week. The primary endpoint of the therapy’s effectiveness will be patients’ scores on the British Isles Lupus Assessment Group Responder Index.
The company designed the Phase 2 study after the FDA encouraged it to move forward on hCDR1. The guidance the agency offered about the trial design included patient population parameters and safety criteria.
An article reporting favorable results of a Phase 2 study (NCT00203151) assessing hCDR1 in lupus patients was published in Lupus Science and Medicine in 2015. The research, “Safety and efficacy of hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study,” showed that 0.5 mg doses of hCDR1 provided significant improvements to lupus patients. BILAG was the study’s measuring instrument.
“2016 was an important year for us, as we continued to lay the foundation for the advancement of hCDR1 towards a global Phase 2 trial designed to have a high likelihood of success based on prior clinical study findings in lupus (SLE),” said Josh Levine, the CEO of XTL.
“In addition, we strengthened the intellectual property of our lead asset, hCDR1, by filing patents on the dosing of our drug for lupus and identifying a potential second indication for our lead asset by filing a use patent for the treatment of Sjögren’s syndrome (SS) based on pre-clinical in vitro data,” he said. “This new data has the potential to significantly increase the market size for hCDR1 in a second indication and further supports the findings found in previous clinical studies performed on lupus.”
HCDR1 is a disease-specific drug that targets autoimmune processes by inducing the generation of regulatory T-cells. The cells can trigger immune signaling cascades that affect immune molecules contributing to lupus, including active B- and T-cells, autoantibodies, and cytokines. The changes are believed to induce a balance in the disturbed immune system of lupus patients.
Robert Fox, MD, and Simon Bowman, MD, two leading experts in rheumatology, will be members of a clinical advisory board that helps guide XTL’s Phase 2 trial.
The company also announced that Dr. Daphna Paran is its new medical director. Paran, an internal medicine and rheumatology specialist, is a world-renowned expert on lupus treatment.