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Orilotimod (Apo805K1) is a synthetic tripeptide immunomodulator consisting of the amino acids L-alanine, L-glutamic acid, and L-tryptophan. Developed by ApoPharma (a subsidiary of Apotex), it was primarily investigated for the treatment of moderate to severe chronic plaque psoriasis. The drug is a derivative of thymodepressin, a known immunosuppressive peptide, and is designed to modulate T-cell activity and suppress the inflammatory cascades that drive psoriatic plaque formation. Clinical development reached Phase 2, including a 12-week dose-escalating study (NCT01465412) to evaluate safety, pharmacokinetics, and efficacy using the Psoriasis Area Severity Index (PASI). Although the Phase 2 trials were completed, there has been no significant public evidence of progression to Phase 3, suggesting development may have been discontinued.
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