XTL Biopharmaceuticals submits protocol for advanced clinical trial of hCDR1 to treat SLE

XTL Biopharmaceuticals Ltd. announced in a press release that it has submitted full study protocol for an advanced stage clinical trial of hCDR1 for the treatment of systemic lupus erythematosus.

The announcement follows the publication of phase 2b trial results. According to the press release, hCDR1 has demonstrated efficacy in at least one clinically relevant endpoint and had a favorable safety profile.

XTL has submitted its pre-investigational new drug meeting package to the FDA, and the company expects to receive the first written responses from FDA during the next few weeks in reference to its proposed clinical study.

XTL is developing the compound under license from Yeda, the technology transfer arm of the Weizmann Institute of Science, according to the release.

“We are pleased to have met this important milestone and to continue our partnership with Yeda in the development of this novel drug for the benefit of lupus patients,” Josh Levine, the chief executive officer of XTL, said in the release. “We are making good progress in all of our regulatory, clinical and chemistry, manufacturing and control (CMC) activities, and expect to meet the remaining development milestones.”

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