XTL Biopharmaceuticals has announced it has submitted the full protocol for its advanced stage clinical trial of hCDR1 in the treatment of systemic lupus erythematosus (SLE, commonly referred to as lupus) to Yeda Research and Development Company in Israel.
According to the Phase II clinical study titled “Safety and efficacy of hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study“ and published in LUPUS Science & Medicine, hCDR1 has a unique mechanism of action and clinical data on more than 400 patients gathered from three clinical studies.
“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. 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,” XTL’s CEO Josh Levine said in a press release.
The Phase 2b clinical trial of hCDR1 has been completed and the compound showed a favorable safety profile in more than 400 patients and efficacy in at least one clinically relevant endpoint.
XTL previously announced a pre-IND (investigational new drug) application meeting package submission to the U.S. Food and Drug Administration.
The company now awaits an answer on its proposed clinical trial. The submission of the clinical protocol sets a milestone for XTL in the development of hCDR1, which the company is developing under Yeda’s license. Yeda Research and Development is the commercial arm of the Weizmann Institute of Science, a public research university in Rehovot, Israel.
“We are encouraged by the progress that XTL has made to date with hCDR1 and we look forward to XTL’s continued development of the drug for the treatment of SLE,” said Amir Naiberg, CEO of Yeda.
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