FDA issues written guidance to XTL Biopharmaceuticals about upcoming IND filing for SLE drug hCDR1

XTL Biopharmaceuticals Ltd. announced the company has received written guidance from the FDA following submission of a full study protocol for hCDR1 as a treatment for systemic lupus erythematosus, according to a company press release.

The guidance recommends the study, which follows a phase 2b study of hCDR1, should be designed as a phase 2 study and include a primary efficacy endpoint based on a British Isles Lupus Assessment Group (BILAG) index.

“We are very pleased with the FDA’s written response to our pre-[investigational new drug] filing meeting package and see it as a vote of confidence in our ability to bring a much needed treatment to people living with lupus,” Josh Levine, chief executive officer of XTL, said in the release.

Other aspects of trial design recommended by the FDA will be reviewed by XTL’s clinical advisory board before finalization of the study protocol.

“This study has an increased likelihood to succeed, in our view, because the FDA’s guidance encourages the study to be substantially similar to the prior phase 2 trial which demonstrated efficacy in the 0.5-mg dose using the BILAG index, the secondary endpoint of that trial,” Levine said in the release. “We believe the FDA’s guidance validates the value and relevance of the safety and efficacy data from the prior phase 2 trial including data on the patient population and statistically significant effect of a 0.5-mg dose of hCDR1 on the BILAG endpoint. Using a primary efficacy endpoint based on the BILAG index, we are hopeful that our upcoming study will produce robust data towards supporting a future [new drug application] NDA filing.”

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