First topical pharmacologic therapy to reduce excess subcutaneous fat shows positive results. Study to be featured as “Late Breaking” research at the upcoming American Academy of Dermatology Annual Meeting
BOSTON, MA, USA I March 4, 2015 I Topokine Therapeutics, the biotech company pioneering the development of topical medications to contour the face and body, today announced that XAF5 Ointment met its pre-specified primary endpoint in a Phase 2 study for the reduction of excess eyelid fat. This condition, which affects most people over the age of 45, is commonly called “eye bags” and technically known as steatoblepharon.
XAF5 Ointment was well tolerated. The study met its primary endpoint on intent-to-treat analysis, with nearly half of patients in the XAF5 group showing bilateral improvement of at least 1 grade on the clinician-reported Lower Eyelid Steatoblepharon Severity (LESS) scale (p = 0.02). XAF5 Ointment was also superior to placebo on a wide array of secondary and exploratory endpoints:
· Mean change in clinician-reported LESS scale (p
· Mean change in patient-reported LESS scale (p
· Patient Satisfaction Scale 1, an instrument that assesses the patient’s perception of eyelid appearance on dimensions of happiness, bother, self-consciousness, embarrassment, old appearance, and tired appearance (p = .001)
· Patient Satisfaction Scale 2, an instrument that assesses cumulative satisfaction with eyelid appearance, face appearance, and the overall treatment (p = .002). Of patients in the XAF5 group, 75% reported improved facial appearance, and 85% were satisfied with the treatment.
“This was a carefully controlled study with multiple, independent physician- and patient-reported endpoints. The results provide a rich, coherent picture of the physical and psychosocial treatment response,” said Michael S. Singer, MD, PhD, a board-certified ophthalmologist and Topokine’s Chief Scientific Officer. “XAF5 not only reduced the volume of eyelid fat but also improved the patient’s overall sense of facial attractiveness. Patients who used XAF5 felt happier about their appearance and reported looking more youthful and well-rested.”
“Eye bags are a very common concern among patients in my dermatology practice,” said Jeffrey S. Dover, MD, FRCPC, a member of the company’s Scientific Advisory Board and past president of the American Society for Dermatologic Surgery. “If approved, XAF5 Ointment would be the first prescription medication to treat this condition.”
“Today’s face and body contouring market is defined by surgery and office-based procedures with injectables and devices,” said Murat Kalayoglu, MD, PhD, the company’s President and CEO. “We believe that existing therapies represent only the tip of the iceberg, with a vast number of people holding out for once-daily topical therapies, such as XAF5 Ointment, for use at home.”
The results will be presented at the annual meeting of the American Academy of Dermatology, San Francisco, on March 21, 2015 by Michael Sheety, MD, FACS, Principal Investigator of the study and Medical & Surgical Director of the OC Surgical Institute.
About Topokine
Topokine is a clinical-stage biotechnology company developing topical prescription medications that act pharmacologically on adipocytes to contour the face and body. The company’s lead program, XAF5 Ointment, is in Phase 2 clinical development for reduction of excess eyelid fat (steatoblepharon) and other indications. Topokine’s pipeline also includes TAT4 Gel, which increases subcutaneous fat and is in clinical development for hand and face rejuvenation. For more information, visit www.topokine.com.
SOURCE: Topokine
Post Views: 129
First topical pharmacologic therapy to reduce excess subcutaneous fat shows positive results. Study to be featured as “Late Breaking” research at the upcoming American Academy of Dermatology Annual Meeting
BOSTON, MA, USA I March 4, 2015 I Topokine Therapeutics, the biotech company pioneering the development of topical medications to contour the face and body, today announced that XAF5 Ointment met its pre-specified primary endpoint in a Phase 2 study for the reduction of excess eyelid fat. This condition, which affects most people over the age of 45, is commonly called “eye bags” and technically known as steatoblepharon.
XAF5 Ointment was well tolerated. The study met its primary endpoint on intent-to-treat analysis, with nearly half of patients in the XAF5 group showing bilateral improvement of at least 1 grade on the clinician-reported Lower Eyelid Steatoblepharon Severity (LESS) scale (p = 0.02). XAF5 Ointment was also superior to placebo on a wide array of secondary and exploratory endpoints:
· Mean change in clinician-reported LESS scale (p
· Mean change in patient-reported LESS scale (p
· Patient Satisfaction Scale 1, an instrument that assesses the patient’s perception of eyelid appearance on dimensions of happiness, bother, self-consciousness, embarrassment, old appearance, and tired appearance (p = .001)
· Patient Satisfaction Scale 2, an instrument that assesses cumulative satisfaction with eyelid appearance, face appearance, and the overall treatment (p = .002). Of patients in the XAF5 group, 75% reported improved facial appearance, and 85% were satisfied with the treatment.
“This was a carefully controlled study with multiple, independent physician- and patient-reported endpoints. The results provide a rich, coherent picture of the physical and psychosocial treatment response,” said Michael S. Singer, MD, PhD, a board-certified ophthalmologist and Topokine’s Chief Scientific Officer. “XAF5 not only reduced the volume of eyelid fat but also improved the patient’s overall sense of facial attractiveness. Patients who used XAF5 felt happier about their appearance and reported looking more youthful and well-rested.”
“Eye bags are a very common concern among patients in my dermatology practice,” said Jeffrey S. Dover, MD, FRCPC, a member of the company’s Scientific Advisory Board and past president of the American Society for Dermatologic Surgery. “If approved, XAF5 Ointment would be the first prescription medication to treat this condition.”
“Today’s face and body contouring market is defined by surgery and office-based procedures with injectables and devices,” said Murat Kalayoglu, MD, PhD, the company’s President and CEO. “We believe that existing therapies represent only the tip of the iceberg, with a vast number of people holding out for once-daily topical therapies, such as XAF5 Ointment, for use at home.”
The results will be presented at the annual meeting of the American Academy of Dermatology, San Francisco, on March 21, 2015 by Michael Sheety, MD, FACS, Principal Investigator of the study and Medical & Surgical Director of the OC Surgical Institute.
About Topokine
Topokine is a clinical-stage biotechnology company developing topical prescription medications that act pharmacologically on adipocytes to contour the face and body. The company’s lead program, XAF5 Ointment, is in Phase 2 clinical development for reduction of excess eyelid fat (steatoblepharon) and other indications. Topokine’s pipeline also includes TAT4 Gel, which increases subcutaneous fat and is in clinical development for hand and face rejuvenation. For more information, visit www.topokine.com.
SOURCE: Topokine
Post Views: 129
