September 20, 2010
LOS ANGELES, September 21, 2010 – KYTHERA Biopharmaceuticals, Inc. (KYTHERA) today announced that it has successfully completed a proof-of-concept study of ATX-202, its pigmentation modulation product, in vitiligo. The trial was a randomized, double-blind, placebo-controlled study of 64 patients conducted at four centers in Delhi, India. Improvement in vitiligo macules was objectively measured via both highly-specific and highly-sensitive analyses of photographic images.
Vitiligo macules treated with a combination of ATX-202 and narrowband ultraviolet-B (NB-UVB) light showed a mean 24.8% re-pigmentation, an 11.0% greater improvement (p-value = 0.0624) when compared to those macules treated with NB-UVB alone (mean 13.7% re-pigmentation) after 12 weeks of treatment. ATX-202 was well tolerated and no significant adverse events were reported.
Given its increased concentration of efforts on lead program, ATX-101, KYTHERA will be discontinuing efforts to pursue ATX-202 as a lead candidate. However, encouraged by both the biological insights gained to date and the opportunity to meet unmet medical needs, KYTHERA plans to continue research efforts in pigmentation disorders broadly.
ATX-202 is a polypeptide that promotes the synthesis of the skin pigment, melanin, by regulating melanocyte function. KYTHERA recently completed a study of ATX-202 in the treatment of the depigmentation disorder, vitiligo.
Vitiligo is a common depigmentation disorder that affects approximately 1-4% of the world’s population. It is characterized by the formation of white spots on the skin that tend to enlarge over time. A pathological hallmark of vitiligo is the absence of melanocytes in the skin. Melanocytes, normally located in the basal layer of the epidermis, are cells that produce the pigment melanin, which gives skin its color.
About KYTHERA Biopharmaceuticals
KYTHERA Biopharmaceuticals, Inc. is a privately held, clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic market. KYTHERA has an innovative pipeline, with its lead program in adipolysis (ATX-101) starting Phase 3 programs this year. The company also has active research programs in facial contouring, pigmentation modulation and hair and fat biology. Find more information at www.kytherabiopharma.com.