An experimental, fast-acting human monoclonal antibody appears safe and effective, according to results of a phase 1 trial published recently in the Journal of Allergy and Clinical Immunology.
BI 655066 was well tolerated and associated with rapid clinical improvement in the single-rising-dose, multicenter, randomized, double-blind, placebo-controlled, within-dose cohort phase 1 trial that included 39 patients with moderate-to-severe psoriasis.
Of those patients, 18 received a single-dose of BI 655066 intravenously, while 13 received the experimental drug subcutaneously; eight patients received placebo. The intravenous dose ranged from 0.01 mg/kg to 5 mg/kg and the subcutaneous dose was either 0.25 or 1 mg/kg.
Regardless of the dose administered via intravenous or subcutaneous route, the researchers reported that the 31 patients who received BI 655066 had clinical improvement beginning at week 2 and maintained through week 66 weeks. Patients in the placebo group had no clinical improvement, according to the results of the study.
“BI 655066 treatment resulted in reduced expression of lesional skin genes associated with IL-23/IL-17 signaling pathways and normalization of psoriatic lesion gene expression profiles to a profile approaching that of nonlesional skin,” the study authors wrote.
The rate of reported adverse events was comparable in both the treatment and placebo groups. Four serious adverse events were reported among BI 655066–treated patients, but were not considered to be related to treatment.
“BI 655066 was well tolerated and associated with rapid, substantial, and durable clinical improvement in patients with moderate-to-severe psoriasis, supporting a central role for IL-23 in psoriasis pathogenesis,” the authors concluded.
Krueger has received personal fees and money for his institution from Pfizer, Janssen, Lilly, Merck, Novartis, Kadmon, Dermira, Boehringer-Ingelheim, and BMS; has received personal fees only from Serono, Biogen Idec, Delenex, AbbVie, Sanofi, Baxter, Xenoport, and Kineta; and has received money for his institution only from Amgen, Innovaderm, Kyowa, and Parexel.