- MC2 Therapeutics on Tuesday released top-line data from a late-stage study of the private company's lead drug candidate that demonstrated superiority in treating psoriasis over an on-market competitor.
- MC2-01 achieved its primary endpoint in a 796-person Phase 3 trial that compared the cream to Taclonex, with nearly twice as many patients given the experimental drug achieving a minimum two-point decrease in the Physician Global Assessment score as did those on Taclonex after 8 weeks.
- The Danish company said it plans to submit a New Drug Application with the Food and Drug Administration for its once-daily treatment for mild-to-moderate psoriasis in the first half of 2019.
MC2 is betting a focus on treatment convenience will pay off.
With MC2-01 (calcipotriene/betamethasone dipropionate), its only drug candidate in Phase 3, the top-line results versus Taclonex appear promising.
MC2-01 is a different take on calcipotriene/betamethasone, which are also the active ingredients in Taclonex. The company said current on-market versions of the drug combo are greasy, which results in low patient compliance. The company touts its delivery vehicle as a key difference, helping the chemicals absorb into the skin quicker and reduce greasiness.
The trial directly compared MC2-01 to Taclonex. Not only did the study achieve the primary goal with more patients experiencing a two-point decrease in the Physician Global Assessment score, but it hit both of its secondary endpoints on patient-reported treatment convenience and a higher percentage reduction in the severity index (mPASI).
Psoriasis is a large market, with a wide range of treatments depending on disease severity and type. Most of the recent focus has been on moderate-to-severe patients, who are typically treated with potent injectable biologics.
TNF inhibitors like Humira (adalimumab) have long had a hold on that end of the market, but new competitors like Novartis' Cosentyx (secukinumab) and Eli Lilly's Taltz (ixekizumab) have upped the competition.
In mild-to-moderate cases, the FDA approved Leo Pharma's Taclonex in 2006 and gave expanded approvals for younger patients in 2008 and a foam formulation in 2015. Generics were first approved by the FDA five years ago and branded sales of Taclonex have since declined, according to a company report.
MC2 said full data will be presented at upcoming conferences, and the company is planning an NDA filing for next year.