Valeant Pharmaceuticals has announced positive results from their second pivotal Phase III clinical trial for their plaque psoriasis topical, IDP-118. The drug is a combination of halobetasol propionate and tazarotene – both of which are approved for the treatment of psoriasis.
The Phase III clinical trial involved 203 adult patients with moderate to severe psoriasis, and took place over an 8-week study period. IDP-118 met its primary endpoint of achieving a “clear” to “almost clear” score in 35.76 percent of patients, compared to just 6.98 percent with the vehicle alone.
“Investing in R&D and developing innovative products that improve people’s lives continue to be priorities as we enter 2017,” said Joseph C. Papa, Chairman and Chief Executive Officer. “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.”
When used on their own, halobetasol propionate and tazarotene have both been associated with adverse events, which could limit their use. According to previous clinical studies conducted by Valeant, the dual mechanism of action of IDP-118 could help reduce the risk of adverse events, thereby expanding use of the active ingredients.
In a previous Phase III clinical trial, IDP-118 was associated with a 45.33 percent treatment success rate at eight weeks, compared to 12.51 percent for the vehicle alone. This study involved 215 adult patients with moderate to severe plaque psoriasis.
The dual formulation was also shown to be more effective that the individual drugs in a Phase II clinical trial. IDP-118 showed a treatment success rate of 52.5 percent over halobetasol propionate and tazarotene, as well as the vehicle.
Valeant has one other plaque psoriasis drugs in the pipeline, known as brodalumab. While a US Food and Drug Administration (FDA) advisory committee has recommended that the regulator approve brodalumab, the drug’s link to six patient suicides during the course of the clinical trials have complicated the FDA’s decision.