Date: 2014-01-08
Type of information: Licensing agreement
Compound: hCDR1
Company: XTL Biopharmaceuticals (Israel) Yeda Research and Development Company (Israel)
Therapeutic area: Autoimmune diseases
Type agreement: licensing
Action mechanism: hCDR1, a peptide developed by Prof. Edna Mozes of the Department of Immunology, The Weizmann Institute of Science, acts as a disease-specific treatment to modify the SLE-related autoimmune process by specific upstream immunomodulation through the generation of regulatory T cells, reducing inflammation and resuming immune balance.
Disease: systemic lupus erythematosus
Details: * On January 8, 2014, XTL Biopharmaceuticals, a clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of pharmaceutical products for the treatment of unmet clinical needs, has announced it has signed a licensing agreement with Yeda Research and Development Company Ltd. (\"Yeda\") to develop hCDR1, a Phase II-ready asset for the treatment of systemic lupus erythematosus (SLE).
Two placebo controlled Phase I trials and a placebo controlled Phase II trial (PRELUDE) were conducted by Teva Pharmaceutical Industries, 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 (SRI). 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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