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KYTHERA Biopharmaceuticals, Inc. Announces Positive Interim Results from Open-Label Phase IIIb Study of ATX-101 at the 11 ^th Anti-Aging Medicine World Congress (AMWC)

Results featured in the “Innovations and Renewals” session

MONTE CARLO, Monaco–(BUSINESS WIRE)– KYTHERA Biopharmaceuticals, Inc. (NAS: KYTH) today announced positive interim results from a Phase IIIb, multicenter, open-label study (ATX-101-11-26) of ATX-101 during the “Innovations and Renewals” session of the 11^th Anti-Aging Medicine World Congress (AMWC), April 4-6, Monte Carlo, Monaco. The study, presented by investigator Susan Weinkle, MD, FAAD, evaluated the safety and efficacy of ATX-101, a potential first-in-class, non-surgical, injectable drug in Phase III trials for the reduction of unwanted submental fat (SMF), commonly known as “double chin.” The results found that ATX-101 is well tolerated and may be effective in reducing SMF by both clinician- and patient-reported outcome measures. AMWC is the world’s largest event for global aging management, and attracts aesthetic dermatologists, surgeons and clinicians in the regenerative, preventative and anti-aging medicine industry from more than 95 countries.

“The positive interim results are consistent with previous ATX-101 studies,” said Weinkle, a board certified dermatologist and affiliate clinical professor at the University of South Florida, Tampa, Fla., U.S. “Worldwide, doctors are receiving requests from their patients for a non-surgical way to treat their double chin. The results of this study suggest that microinjections of ATX-101 have an acceptable safety profile and can reduce the appearance of a double chin with high patient satisfaction.”

ATX-101 is a proprietary formulation of synthetically-derived deoxycholic acid (DCA), a molecule found in the body that helps break down dietary fat. In this open-label Phase IIIb study, interim results three months after the last ATX-101 treatment are outlined below. Observations were made using validated rating instruments for which one-grade changes are considered to be clinically meaningful:

Reduction of submental fat
- 87 percent of patients achieved at least a one-grade improvement from baseline on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
- Similarly, 83 percent of patients achieved at least a one-grade improvement on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
96 percent of patients had unchanged or improved skin laxity based on the clinician rated Submental Skin Laxity Grading Scale (SMSLG)

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KYTHERA Biopharmaceuticals, Inc. Announces Positive Interim Results from Open-Label Study of ATX-101 in the Reduction of Unwanted Submental Fat (SMF) or “Double Chin”

Results presented at 2013 American Academy of Dermatology (AAD) Late Breaking Research Symposium

MIAMI BEACH, Fla.–(BUSINESS WIRE)– KYTHERA Biopharmaceuticals, Inc. (NAS: KYTH) today announced positive interim results from a Phase IIIb, multi-center, open-label study (ATX-101-11-26) to evaluate the safety and efficacy of ATX-101, an investigational injectable drug for the reduction of unwanted submental fat (SMF), commonly known as double chin. The results, presented at the Late Breaking Research Symposium at the 71^st American Academy of Dermatology (AAD) Annual Meeting in Miami Beach, Fla., found that ATX-101 is well-tolerated and may be effective in reducing SMF by both clinician and patient reported outcome measures. The ATX-101 global clinical development program has enrolled more than 2,500 total patients, of which more than 1,500 have been treated with ATX-101.

“In my practice, patients often request a non-surgical way to treat their submental fat, or undesirable double chin,” said investigator Susan Weinkle, MD, FAAD, a board certified dermatologist and affiliate clinical professor at the University of South Florida. “For these patients, double chin is often resistant to diet and exercise. The results of this study suggest that microinjections of ATX-101 can reduce submental fat without worsening skin laxity.”

ATX-101 is a proprietary, synthetically-derived formulation of deoxycholic acid (DCA), a naturally-occurring molecule found in the body that aids in fat metabolism. In this open-label Phase IIIb study, interim results three months after the last ATX-101 treatment found:

Reduction of submental fat
- 87 percent of patients achieved at least a one-grade improvement from baseline on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
- Similarly, 83 percent of patients achieved at least a one-grade improvement on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
96 percent of patients had unchanged or improved skin laxity based on the clinician rated Submental Skin Laxity Grading Scale (SMSLG)
95 percent of patients were satisfied with treatment based on the Global Post Treatment Satisfaction Scale
Adverse events were of mild to moderate intensity, transient and primarily associated with the treatment area

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KYTHERA Biopharmaceuticals, Inc. Announces Positive Interim Results from Open-Label Phase IIIb Study

KYTHERA Biopharmaceuticals, Inc. Announces Positive Interim Results from Open-Label Study of ATX-101

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