MC2 Therapeutics reports positive Phase III results for experimental psoriasis cream

MC2 Therapeutics on Tuesday announced that its investigational psoriasis cream MC2-01 (calcipotriene/betamethasone) demonstrated "significant superiority" in a Phase III trial in terms of both treatment success and patient reported treatment convenience compared to Leo Pharma's Taclonex (calcipotriene/betamethasone) topical suspension. MC2 Therapeutics indicated that it plans to submit a marketing application for its product with the FDA in the first half of 2019.

The study enrolled 796 patients with psoriasis vulgaris who were randomly assigned to treatment with MC2-01 or Taclonex. The primary efficacy endpoint was the proportion of patients at week eight who achieved treatment success, defined as at least a two-point decrease from baseline in the Physician Global Assessment score.

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Results from the study demonstrated that 40.1 percent of patients in the MC2-01 group exhibited treatment success, versus 24 percent of those treated with Taclonex, meeting the primary endpoint of non-inferiority.

In regards to secondary goals, MC2-01 was associated with a 64.8-percent reduction in modified Psoriasis Area and Severity Index score from baseline to week eight, compared to a reduction of 52.3 percent for Taclonex. The company said MC2-01 was also "superior" to Taclonex in terms of patient treatment convenience, and the cream provided a "robust reduction" in itch at week four, as measured by the frequency of a four-grade or greater improvement on an 11-point numeric rating scale of itch severity.

"Adverse events seen in the trial were predictable pharmacological class effects typically associated with calcipotriene and topical corticosteroids," the company said, adding that "the safety profile of MC2-01 cream was similar to that known from Taclonex." Full data from the study will be presented at future research conferences.

MC2 Therapeutics explained that MC2-01 was developed using its proprietary PAD Technology. CEO Jesper Lange stated "these data confirm the tremendous potential for PAD technology as a broad platform for the development of new topical drugs that releases the full potential of the active ingredients, while being very pleasant to use for patients in daily routines."

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