September 21, 2010
LOS ANGELES, September 21, 2010 – KYTHERA Biopharmaceuticals, Inc. (KYTHERA) today announced that it has completed a proof of concept (POC) study evaluating efficacy, safety, tolerability and histological effects of ATX-104, a light-activated facial contouring agent.
Pre-clinical testing of ATX-104 demonstrated KYTHERA’s proprietary photochemistry platform allowed effective contouring and improved persistence of shape of currently available dermal fillers materials. Similarly, evaluation of ATX-104 in the clinical POC study demonstrated its ability to maintain its shape and improve persistence. ATX-104 implants retained nearly 100% of height from baseline (a proxy measure for shape) throughout the 12-week study, whereas the hyaluronic acid control implants decreased by 25% - 50% (p<0.05). Adverse events for both ATX-104 and control implants were mild, transient and predictable. However, histological evaluation of ATX-104 revealed the potential for unacceptable adverse events to develop.
“Hyaluronic acids have set the industry standard for dermal fillers from a safety perspective,” said Patricia Walker, MD, PhD, KYTHERA’s Chief Medical Officer. “We held ATX-104 to the same safety profile and found the potential exists for foreign body reactions with ATX-104. As a company committed to bringing novel, safe and efficacious products to the aesthetic medicine market, this potential adverse reaction was not acceptable to us.” Given the efficacy demonstrated in the feasibility trial, the market potential, and positive physician feedback, KYTHERA will continue to pursue research collaboration with Johns Hopkins University with the aim of developing a novel facial contouring agent. These research efforts will focus on optimization to improve the safety profile while retaining the positive efficacy attributes.
ATX-104 is a light-activated facial contouring agent based on KYTHERA’s photochemistry platform. ATX-104 is designed to be injected, shaped and polymerized transdermally, in-situ with a proprietary light source. Transdermal photo-polymerization technology provides the ability to alter the mechanical properties of ATX-104 post-injection. In preclinical models, altering the mechanical properties in-situ allowed maintenance of optimal pre-injection mechanics of filler while dramatically improving its persistence and contouring properties.
About KYTHERA Biopharmaceuticals
0KYTHERA 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.