Market Overview

MC2 Therapeutics Announces Positive Top-line Results from Phase 3 Clinical Trial Comparing MC2-01 Cream to Taclonex® in Adults with Psoriasis


MC2-01 Cream demonstrates statistically significant superiority in
both treatment success and patient reported treatment convenience
compared to Taclonex
® Topical Suspension. Both
primary and secondary endpoints were met and a submission of NDA to the
FDA is now planned for H1 2019.

MC2 Therapeutics A/S, an emerging pharmaceutical company developing next
generation patient-friendly topical therapies for skin and eye diseases,
today announced the following top-line data from its US Phase 3 study
(n=796) on the company's investigational drug, MC2-01 Cream
(calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%):

Primary end-point

  • MC2-01 Cream is superior to Taclonex® Topical Suspension
    ("Taclonex®") at Week 8 based on treatment success defined
    as a minimum two-point decrease in the Physician Global Assessment
    (PGA) score (40.1% versus 24.0%, p < 0.0001). Accordingly, the trial
    met its primary endpoint to demonstrate non-inferiority of MC2-01
    Cream to Taclonex®.

Secondary endpoints

  • MC2-01 Cream is superior to Taclonex® based on percentage
    reduction in mPASI from baseline to Week 8 (64.8% versus 52.3%, p <
    0.0001) (MC2-01 Cream demonstrated fast onset of action with
    superiority (p < 0.009) to Taclonex® already at Week 1).
  • MC2-01 Cream is superior to Taclonex® in Patient Treatment
    Convenience (p < 0.0001)
  • MC2-01 Cream provides a robust reduction in itch (60.2% at Week 4)
    measured by the frequency of a four-grade or greater improvement on an
    11-point numeric rating scale of itch severity.

"The significant improvements in both treatment success and patient
reported treatment convenience are particularly encouraging," said Linda
Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford
Health System in Detroit, Michigan, and lead investigator in the study.
"Enhanced patient satisfaction enabled by the MC2-01 Cream PAD™
formulation may increase treatment compliance among patients, and
positively impact real-life treatment outcomes even further. As such
PAD™ Technology holds the promise of redefining topicals."

The adverse events seen in the trial were predictable pharmacological
class effects typically associated with calcipotriene and topical
corticosteroids, and the safety profile of MC2-01 cream was similar to
that known from Taclonex®.

MC2 Therapeutics is pursuing a patient-centric approach to treating
psoriasis by developing a once-daily, non-greasy topical treatment that
can be conveniently applied to a large surface area of the body and
absorbs quickly into the skin to provide rapid symptom relief. MC2-01
Cream is designed to allow patients to comfortably wear clothes
immediately after application and go about their daily routines.

"We are extremely pleased with these superiority data from the
head-to-head study of MC2-01 Cream versus Taclonex®, which is
widely regarded as a first line topical treatment of psoriasis," stated
Jesper J. Lange, President of MC2 Therapeutics. "Psoriasis is a
life-long condition that significantly impacts patients'

quality of life. MC2-01 Cream is designed to provide patients a new
standard of care for the topical treatment of psoriasis that helps them
effectively and conveniently manage their condition and minimize
disruption to their daily routine and social interactions."

Lange added, "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. PAD™ Technology
enables an expanded formulation space that opens the door for an array
of new topical therapies that might not otherwise be developed e.g. due
to challenges with delivery, solubility and stability of active

About the MC2-01 Phase 3 Trial

This Phase 3, randomized, multicenter, investigator-blind,
parallel-group trial evaluated the efficacy and safety of MC2-01 Cream
compared to MC2-01 vehicle and the active comparator (Taclonex®)
in subjects with psoriasis vulgaris. The trial enrolled 796 patients at
55 dermatologists across the United States. Subjects applied trial
medication topically once daily for eight weeks.

The primary objective was to show therapeutic non-inferiority of MC2-01
Cream to the active comparator, as well as to characterize the safety
profile of MC2-01 Cream in subjects with psoriasis vulgaris. The primary
efficacy endpoint was the proportion of subjects in each treatment group
with "treatment success" at week eight, defined as a minimum two-point
decrease from baseline in PGA score (i.e., a score of 0 (clear) or 1
(almost clear) disease for subjects with moderate disease at baseline,
or a score of 0 (absent) for subjects with mild disease at baseline).

The full data from the trial will be presented at upcoming medical
conferences. Global development of MC2- 01 will continue and MC2
Therapeutics plans to submit a New Drug Application (NDA) to FDA in the
first half of 2019.

About MC2 Therapeutics A/S

MC2 Therapeutics A/S is a privately held pharmaceutical company that is
applying its proprietary PAD™ Technology as a broad platform to enable
the development of a new generation of patient friendly topical
prescriptions and consumer healthcare products. The Company is advancing
its own portfolio of products to treat skin and eye conditions and is
collaborating with other pharmaceutical companies to unlock the full
potential of their active pharmaceutical ingredients in new topical drug

For additional information on MC2 Therapeutics Group, please visit

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