Lupuzor, a non-immunosuppressant therapy for lupus created by Dr. Sylviane Muller’s team at the CNRS Immunopathologie et Chimie Thérapeutique laboratory, is progressing to a Phase 3 clinical trial, the last stage before possible market approval. Several American and European physicians and investigators recently gathered in Paris to discuss the launch of this trial.
Lupuzor is part of a family of peptides that can correct immune system dysfunctions. One of these protein fragments, P140, was shown to delay the development of lupus in mouse models of the disease, while at the same time not compromising the immune system’s ability to fight eventual infective agents.
The therapy’s Phase 1, Phase 2a and Phase 2b trials, supervised by ImmuPharma-France which holds a license patent over this peptide family, showed positive results, leading to the drug candidate’s advancement to Phase 3. Importantly, during Phase 2 trials, lupus was found to regress in 62% of patients after three months of treatment, which constitutes the best regression result yet achieved for this pathology. The Phase 3 trial, as in Phase 2b, will be a double-blind study with patients receiving the drug at 200 µg per injection, via the subcutaneous route. The duration of the study will be extended to a full year.
The trial will enroll 200 patients, recruited from 10 U.S. centers and 35 centers in Europe. The trial is expected to begin this month in the U.S. and by mid-January in Europe, with recruitment to be completed by mid-2016 (and by the close of 2015 in the U.S.). The final results are anticipated for the end of 2017.
If expectations of promising results are met and the drug is approved, it could become a central therapy for lupus patients. Lupuzor holds great promise as a much-needed target therapy, since most agents used for disease management, such as corticosteroids and immunosuppressants, are not only non-specific but also weaken the immune system, leaving the patient in a vulnerable position.
According to a press release, preclinical findings also point to Lupuzor’s potential benefit for other chronic autoimmune pathologies, such as Sjögren’s syndrome and Crohn’s disease.