Treatment with IDP-118 (halobetasol propionate and tazarotene), a lotion developed by Valeant Pharmaceuticals, successfully improved the signs and symptoms of plaque psoriasis, according to the results of a second and confirmatory Phase 3 clinical study.
The double-blind, randomized clinical trial (NCT02462070) evaluated IDP-118’s effectiveness and safety in 203 adults with moderate to severe psoriasis. Its primary endpoint was the percentage of subjects with treatment success, as defined as at least a two-grade improvement from baseline on an investigator global assessment (IGA) score, and an IGA score equating to “clear” or “almost clear” skin.
IGA scores are determined based on investigator evaluation of the overall signs and symptoms of plaque psoriasis, scored on a scale of 0 (clear), 2 (mild), 3 (moderate), or 4 (severe).
After eight weeks, the lotion showed statistical importance to a comparator lotion, with a treatment success rate of 35.76 compared to 6.98 percent, Valeant reported in a press release. Patients in the 12-week study, which included eight weeks of daily treatment, achieved “clear” to “almost clear” skin scores at eight weeks, and at least a two-grade improvement in IGA at weeks 12, six, four and two, the study’s secondary goals.
“Investing in R&D and developing innovative products that improve people’s lives continue to be priorities as we enter 2017,” Joseph C. Papa, chairman and chief executive officer, said in the release. “We are optimistic about the results of this confirmatory Phase 3 study, which demonstrate that the novel formulation in IDP-118, with its dual mechanism of action, can achieve greater efficacy at a much lower concentration while reducing irritation in patients who use a corticosteroid-retinoid combination to treat psoriasis.”
IDP-118 is a combination of two currently approved medications, halobetasol propionate, a corticosteroid, and tazarotene, a retinoid prodrug also used to treat acne. Each of these medications can cause adverse reactions that affect how long it is used. Based on results from its studies, Valeant believes that by combining these two ingredients, IDP-118 allows for longer use with potentially minimal skin reactions.
Valeant reported the results of its initial Phase 3 clinical trial (NCT02462122) in 215 adults with moderate to severe plaque psoriasis in December. Treatment with IDP-118, again for eight weeks, resulted in a statistically significant success rate of 45.33 percent, compared to 12.51 percent for a comparator lotion. This 12-week study also defined success as at least two-grade improvement on IGA scores at eight weeks.
The Phase 3 clinical program was preceded by a multicenter, double-blind, randomized Phase 2 clinical trial (NCT02045277), where IDP-118 achieved a treatment success rate of 52.5 percent, superior to each of its active ingredients (halobetasol propionate and tazarotene), and to a comparator lotion.