Cassiopea is focused on developing and commercializing innovative and differentiated medical dermatology products. This market is characterized by a large patient population that is primarily served by a relatively small, and therefore accessible, number of treating physicians, principally dermatologists. The 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. These product candidates are based on three new chemical entities (NCEs), and target unmet medical needs and significant market opportunities in the medical dermatology market.
The field of dermatology and skin care has experienced significant growth in the last several years. Based on research by VisionGain, the global dermatological drugs market generated revenues of $22.6 billion in 2013, an increase of 7.3% over 2012. Dermatological diseases and disorders may result from a number of factors, including aging, sun damage, immunological conditions, genetics, viral, fungal or bacterial infections, allergic reactions and emotional or seasonal factors, and can significantly impact an individual’s physical and mental health and perceived social acceptance. We believe that many factors are continuing to drive growth in the dermatology market, including new medical technologies, increased patient demand for dermatologic products, growth in the number of physicians dispensing products and an aging population.
- We are developing our lead late stage product candidate Winlevi™ as a first-in-class anti-androgen. Winlevi™ is a topical treatment of acne and has recently showed positive Phase IIb results. In this 360 patient study, Winlevi™ achieved statistical significance in both its co-primary endpoints, inducing a 2 point reduction in the Investigator Global Assessment, or IGA, endpoint and a statistically significant reduction in total lesion count compared to placebo. We submitted a Special Protocol Assessment, or SPA, to the FDA on April 3, 2015 and we expect to initiate a Phase III study with this novel, first in class topical anti-androgen in the second half of 2015 and expect that we will release clinical results from this study in the second half of 2017.
- We are developing our second clinical candidate, Breezula™, for the treatment of AGA. Breezula™ is currently undergoing Phase II development. It represents a different formulation and dosage strength of the same NCE as in Winlevi™. In a recent Phase I / II proof of concept study, Breezula™ demonstrated an ability to increase hair shaft diameter and have a positive impact on scalp hair follicle density, in addition to several other positive endpoints. The ongoing 90 patient, 3 arm placebo and standard-of-care controlled Phase II study is 90% enrolled with clinical results expected by the end of 2015.
- We are developing our third clinical candidate, CB-06-01, for the treatment of acne. CB-06-01 is currently in Phase II development with clinical results expected in the first half of 2016. We anticipate that this NCE will be very complementary to Winlevi™ should both reach market. The drug has shown very potent and selective activity in bacterial strains responsible for acne that are resistant to some other antibiotics.
- Our fourth clinical compound, CB-06-02, for the treatment of genital warts, is currently in Phase II development with clinical results expected in first half of 2016. This tellurium-based topical product has demonstrated safety in hundreds of patients and also shown potent anti-viral activity on cutaneous viral warts.