KYTHERA Biopharmaceuticals, Inc today announced that it has entered into separate license agreements with Actelion Pharmaceuticals Ltd. and the University of Pennsylvania for a novel approach for the treatment of hair loss, which together could enable KYTHERA to bring a new treatment to the very large and still highly unsatisfied hair loss market.
“These two licenses build on KYTHERA’s focus on developing and commercializing high-value, self-pay aesthetic products that have the promise to yield high patient satisfaction and enhanced self image,” said Keith Leonard, KYTHERA’s president and CEO. “Based on several years of research and clinical work already accomplished, we believe we have the possibility of reaching initial proof-of-concept data in a very capital efficient manner.”
Under the terms of the agreement with Actelion, KYTHERA Holdings Ltd., a wholly-owned Bermuda subsidiary of KYTHERA Biopharmaceuticals, Inc., licensed the worldwide rights to setipiprant, a clinical-stage selective and potent oral antagonist to the prostaglandin D2 (PGD2) receptor.
As part of the agreement, Actelion will be eligible to receive up to $27 million in potential development and regulatory milestones, as well as royalties on sales if setipiprant is successfully commercialized.
Under the terms of the agreement with the University of Pennsylvania, KYTHERA Holdings Ltd., acquired exclusive worldwide rights to certain patent rights owned by the University of Pennsylvania covering the use of PGD2 receptor antagonists for the treatment of hair loss (often presenting as male pattern baldness, or androgenic alopecia) under a license agreement facilitated by the Penn Center for Innovation.
The discovery of the relationship between PGD2 and hair loss was made in the laboratory of Dr. George Cotsarelis and published in late 20111. KYTHERA has been supporting research in Dr. Cotsarelis’ lab at the University of Pennsylvania over the last two years under sponsored research and option agreements to further develop and elucidate the initial reported observations.
“The University of Pennsylvania’s discovery and associated intellectual property assets, combined with access to the PGD2 antagonist setipiprant, provide KYTHERA a strong foundation for this novel approach to hair loss,” said Frederick Beddingfield, III, M.D., Ph.D., KYTHERA’s Chief Medical Officer.
“These observations are potentially the most innovative new thinking in hair loss over the last two decades. Setipiprant is believed to directly affect this hair loss pathway, and our own preclinical and in vitro human hair models confirmed this effect.
It is a well-characterized molecule with a large safety database and we believe we can quickly initiate a development program to study it in hair loss.
Putting these two pieces of the puzzle together is ideal and represents an example of our approach to scientifically sound and efficient drug development.”
KYTHERA plans to conduct a human proof-of-concept study to establish the efficacy of setipiprant in male subjects with androgenic alopecia (AGA).
Setipiprant is a selective oral antagonist to the prostaglandin D2 (PGD2) receptor. The elevation of PGD2 levels in certain regions of the male scalp is associated with hair loss in those regions. In early research studies, PGD2 inhibitors were found to extend the anagen (growth) phase of the hair cycle, thereby promoting the growth of hair.
Setipiprant had previously been studied as a potential allergic inflammation treatment and had undergone eight clinical trials, including a Phase III study 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.
Actelion suspended the development of setipiprant due to a lack of efficacy seen in the above-mentioned clinical trials for inflammatory disorders. Treatment in all studies was well tolerated across all treatment groups and no serious adverse events were reported.
About the Penn Center for Innovation
The Penn Center for Innovation (PCI) is devoted to commercial partnering, licensing and advancement of University of Pennsylvania technologies, innovations and intellectual property. PCI seamlessly connects Penn researchers with business and industry partners. For more information on PCI, please visit www.pci.upenn.edu.
About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. KYTHERA’s lead product candidate, ATX-101, is currently in late-stage clinical development for the reduction of submental fat, which commonly presents as a double chin, and is a potential first-in-class submental contouring injectable drug.
KYTHERA submitted its New Drug Application for ATX-101 in May 2014, and will have a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015. KYTHERA also maintains an active research interest in hair and fat.