8:02AM XTL Biopharma announced it has signed a licensing agreement with Yeda Research and Development Company to develop hCDR1, (XTLB) 2.73 : Co announced it has signed a licensing agreement with Yeda Research and Development Company to develop hCDR1, a Phase II-ready asset for the treatment of Systemic Lupus Erythematosus.
Two placebo controlled Phase I trials and a placebo controlled Phase II trial were conducted by Teva Pharmaceutical (TEVA) which had previously in-licensed hCDR1 from Yeda. The Phase I and Phase II studies consisted of over 400 patients, demonstrating that hCDR1 is well tolerated by patients and has a favorable safety profile. The PRELUDE trial did not achieve its primary efficacy endpoint based on the SLEDAI scale, resulting in Teva returning the asset to Yeda. However, the PRELUDE trial showed encouraging results in its secondary clinical endpoint, the BILAG index, and, in fact, the 0.5 mg weekly dose showed a substantial effect. Multiple post-hoc analyses also showed impressive results for this dose using the BILAG index. Such dose will be the focus of the clinical development plan moving forward.
The FDA has since directed that the primary endpoint in future trials for Lupus therapies, including those for hCDR1, should be based on either the BILAG index or the SLE Responder Index. Given the FDA's recommendation and the positive findings from the PRELUDE trial, XTL intends to initiate a new Phase II clinical trial, which will include the 0.5 mg (and a 0.25 mg) weekly dose of hCDR1.
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