Kythera Biopharmaceuticals Submits Investigational New Drug Application for KYTH-105 to Treat Androgenetic Alopecia, or Male Pattern Hair Loss
KYTHERA Biopharmaceuticals, Inc. today announced it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for KYTH-105 (setipiprant) for treatment of androgenetic alopecia (AGA), or male pattern hair loss.
KYTHERA plans to conduct a human proof-of-concept study to evaluate the efficacy and safety of setipiprant in male subjects with AGA, an inherited genetic disorder that is characterized by a recession of the hairline, hair thinning and progression to partial or complete baldness in men.
Studies have shown that AGA has a significant impact on self-image, and men with the condition are likely to suffer from psychosocial complications including depression, low self-esteem, an altered self-image and less frequent social engagement.
With more than 35 million American men experiencing hair loss, the demand for a safe and effective treatment remains high.
“This submission is a significant milestone in the development of KYTH-105 for male pattern hair loss,” said Frederick Beddingfield, III, M.D., Ph.D., KYTHERA Chief Medical Officer.
“KYTH-105 represents a unique scientific approach to the treatment of hair loss that has the potential to help millions of men achieve a positive self-image.”
Setipiprant is a selective oral antagonist of the prostaglandin D2 (PGD2) receptor – a possible key variable in hair loss – and is a well-characterized molecule supported by a large safety database.
Setipiprant has been previously evaluated by Actelion Pharmaceuticals Ltd. in nine clinical studies as a potential allergic inflammation treatment, including a Phase III trial in seasonal allergic rhinitis patients and a Phase II proof-of-concept study in asthma patients, resulting in a safety database of more than 1,000 patients with no safety issues identified.
Early research in male pattern hair loss found that men with AGA have elevated levels of PGD2 in the balding scalp area.
In preclinical and in vitro human hair follicle models, PGD2 inhibitors like KYTH-105 were found to extend the anagen, or growth phase of the hair cycle, thereby promoting the growth of hair.
KYTHERA is pursuing the clinical development of KYTH-105 under two separate license agreements with Actelion Pharmaceuticals Ltd. and the University of Pennsylvania, which provide KYTHERA with exclusive worldwide rights to KYTH-105, as well as certain patent rights covering the use of PGD2 receptor antagonists for the treatment of hair loss.
KYTHERA Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market.
KYTHERA’s longer-term strategy is to leverage its biotechnology and aesthetics experience to expand its product portfolio and pipeline. Find more information at www.kythera.com.