- Thinly traded nano cap XTL Biopharmaceuticals (XTLB) is up 10% out of the blocks this morning in response to its announcement that has received encouraging written guidance from the FDA ahead of its IND filing for lead product candidate, hCDR1, for the treatment of lupus erythematosus (SLE).
- The agency suggests that the primary efficacy endpoint be based on a measure of lupus disease activity called the BILAG index, which was the secondary endpoint in a prior Phase 2 study of hCDR1. It also recommends the study be run as a Phase 2 and includes guidance regarding the appropriate patient population and the number of subjects needed to prove safety.
- According to the company, the trial design, based on the FDA's feedback, increases its likelihood of success since it will be substantially the same as the prior Phase 2 study which showed efficacy in the 0.5 mg dose as measured by the BILAG index.
- SLE, a chronic autoimmune disorder, affects more than 5M people worldwide. There has been only one drug approved by the FDA in the past 50 years to treat the disease [Glaxo's (GSK +0.4%) Benlysta (belimumab)]. Two drugs in late-stage development failed to achieve their primary efficacy endpoints, demonstrating the challenging nature of SLE.