XTL Biopharmaceuticals Ltd., a clinical-stage biopharmaceutical company developing its lead product for the treatment of lupus, has filed a new patent application with the US Patent and Trademark Office (USPTO) to protect doses of hCDR1 lower than 0.5 mg weekly, in the treatment of Systemic Lupus Erythematosus (SLE).
The new patent application is based on clinical evidence that lower doses of hCDR1 may be as efficient, or in some instances more efficient, than the higher doses previously tested in the treatment of SLE. Lower doses of hCDR1 may improve clinical outcomes in SLE patients when used as a standalone treatment, or when used as a combination therapy in addition to standard of care. Improved outcomes may include the potential to control disease activity in patients who do or do not require steroids. For patients who do require steroids, an hCDR1 combination therapy may decrease the dosage of steroids required to control disease activity.
"We are pleased to expand the intellectual property assets around hCDR1, based on clinical data showing hCDR1 may be effective at doses lower than the 0.5 mg weekly, which has shown statistically significant efficacy as compared to placebo in a prior Phase 2 study," said Josh Levine, CEO of XTL. "While, as a new chemical entity, hCDR1 already will be entitled to data exclusivity, this patent application adds to a robust and growing portfolio of applications and issued patents in key markets around the world."
XTL completed its phase 2 clinical trial design for hCDR1 in the treatment of SLE earlier this year. The trial design includes a treatment arm dosing weekly at 0.5 mg hCDR1 and BILAG as the measure for the primary efficacy endpoint. Data from the prior phase 2 study clearly showed a statistically significant effect of a 0.5 mg dose of hCDR1 on the BILAG index.
hCDR1 is a novel compound with a unique mechanism of action and has 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.
Lupus is a chronic inflammatory autoimmune disease involving many systems in the human body, including joints, kidneys, central nervous system, heart, hematological system and others. The biologic basis of the disease is dysregulation of the immune (defense) system, leading to production of self (auto) antibodies attacking the normal organs and causing irreversible damage. According to the Lupus Foundation of America, at least 1.5 million Americans have the disease (more than 5 million worldwide) with more than 16,000 new cases diagnosed each year. The majority of patients are women of childbearing years. There has been only one drug approved by the FDA in the last 50 years and recently two of the few drugs in advanced development did not meet their primary endpoints in phase 3 trials.