RAANANA, Israel, Dec. 6, 2016 /PRNewswire/ -- XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) (“XTL” or the “Company”), a clinical-stage biopharmaceutical company developing its lead product for the treatment of autoimmune diseases including lupus, today reported financial results for the three and nine months ended September 30, 2016, as well as a clinical and operational update on the development program for its lead drug candidate hCDR1 in the treatment of Systemic Lupus Erythematosus (SLE).
“During the first nine months of 2016 we achieved important milestones towards commencing our Phase 2 hCDR1 study, which we believe is designed to reveal strong efficacy results for our drug in the treatment of SLE. The trial design is based on very encouraging feedback from the U.S. FDA regarding BILAG as the efficacy endpoint and 0.5 mg as the weekly dosage of hCDR1. These are parameters that produced successful results in a prior trial,” stated Josh Levine, CEO of XTL. “We continue to build our hCDR1 IP portfolio with three patents granted for hCDR1 and the filing of two new patent applications in the US since the beginning of the year. We are also investigating hCDR1’s potential use in other autoimmune indications.”
Clinical and Operational Update:
- Prepared to Commence Phase 2 Trial
XTL completed the clinical trial design of its Phase 2 study of hCDR1 in the treatment of SLE. The protocol was designed in consultation with its world renowned Clinical Advisory Board and based on encouraging feedback from a pre-investigational new drug (IND) meeting package submission to the U.S. Food and Drug Administration (FDA). The trial design includes a treatment arm dosing weekly at 0.5 mg hCDR1 and BILAG, a measure of lupus disease activity, 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. XTL believes the FDA’s guidance will improve the likelihood of a successful trial. The FDA’s guidance also included parameters on patient inclusion criteria and patient population for safety requirements for marketing approval.
- Production Batches of hCDR1 Ready for Phase 2 Trial
XTL completed production of representative batches of hCDR1 with BioConnection NV earlier in 2016. These manufactured batches advance XTL’s chemistry, manufacturing and controls (CMC) program for the planned Phase 2 trial of hCDR1.
- Strengthened Intellectual Property Portfolio
During the third quarter, hCDR1 was granted an important patent in Europe titled, “Parenteral Formulations of Peptides for the Treatment of Systemic Lupus Erythematosus,” which addresses non-oral drug formulations of hCDR1 in the treatment of SLE. Patents were also issued for hCDR1 in Hungary and Israel earlier this year. In a move to further broaden hCDR1’s intellectual property rights, two new patent applications were filed with the U.S. Patent and Trademark Office to protect doses of hCDR1 at and below 0.5 mg weekly in the treatment of SLE.
Financial Overview
XTL reported $2.3 million in cash and cash equivalents as of September 30, 2016. Funds will be used to advance the hCDR1 clinical program for the treatment of SLE, to investigate its use in other indications and to identify additional assets for the treatment of other autoimmune diseases.
Research and development expenses for the quarter ended September 30, 2016 were $35,000 compared with $134,000 for the same period in 2015. For the nine months ended September 30, 2016 research and development expenses were $390,000 compared with $245,000 for the same period in 2015. The year to date increase reflects the Company’s increased investment in the hCDR1 clinical program and preparations for a Phase 2 clinical trial. Development activities include the completion of the trial design for the planned Phase 2 trial of hCDR1 for the treatment of SLE, production of the drug product for that trial and investigation of the use of hCDR1 in other autoimmune indications. Initiation of the Phase 2 clinical trial in SLE will require the Company to raise additional capital.
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