Lainate – November 12, 2015 – Cassiopea SpA (SIX: SKIN) announced today that it has commenced the enrolment of patients into the phase III pivotal trials for Winlevi, a novel topical anti-androgen, for acne. The first patients were enrolled in the US on November 9.
The WinleviTM phase III clinical trial program consists of two pivotal trials in approximately 70 sites in both the US and various countries in Europe. Approximately 1,400 male and female subjects 9 years or older with moderate to severe acne (grades 3-4 on IGA) are targeted for enrolment.
The primary endpoints are the proportion of subjects achieving success at week 12 with success meaning an IGA score of “clear” (score =0) or “almost clear” and at least a two-point reduction in IGA and an absolute change from baseline in both inflammatory and non-inflammatory lesion counts in each treatment group at week 12.
The Company expects data to be available in the second half of 2017.
If approved, Winlevi, a New Chemical Entity, will be the first topical anti-androgen for the treatment of acne and will create a new mechanism of action in this important disease state in dermatology. No New Chemical Entity for acne has been approved since the mid 1990s.
Cassiopea SpA is a clinical-stage specialty pharmaceutical company focused on developing and commercializing innovative and differentiated medical dermatology products. Initial focus is on the topical treatment of acne, androgenic alopecia (or AGA) and genital warts. The portfolio comprises four unencumbered clinical candidates, for which Cassiopea owns the worldwide rights. The company plans to commercialize the products directly in the US and partner the products outside of the US. For further information on Cassiopea, please visit www.cassiopea.com.
|Full-year results 2015 reporting||March 1, 2016|
|Annual General Meeting||March 24, 2016|
Dr. Chris Tanner, CFO and Head of Investor Relations
Tel: +39 02 868 91 124
Some of the information contained in this press release may contain forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cassiopea has no obligation to publicly update or revise any forward-looking statements.