Bayer AG (BAYRY) recently presented results from two European phase III studies on ATX-101. ATX-101 is being developed for the reduction of unwanted fat deposits under the chin known as submental fat (SMF).
Bayer enrolled 723 patients for the multi-center, randomized, double-blind, placebo-controlled studies in 57 centers across the UK, France, Germany, Belgium, Spain and Italy.
Results from the studies showed that ATX-101 reduced SMF more than placebo. ATX-101 demonstrated significant improvement in clinician-reported measurements of SMF, supported by objective caliper measurements of SMF thickness, in comparison to placebo.
Results also revealed that patients were more satisfied with their chin appearance and their treatment with ATX-101 than placebo. The candidate was well tolerated in both the studies.
We note that the studies are part of the ATX-101 clinical development program which is being conducted jointly by Bayer and Kythera Biopharmaceuticals Inc. (KYTH) since 2010. As per the 2010 licensing deal between the companies, Bayer acquired rights to ATX-101 in markets outside the US and Canada.
Kythera retained all development and marketing rights for all potential indications of the candidate in the US and Canada. Kythera is eligible to receive tiered double-digit royalties on the sales of the drug made by Bayer outside the US and Canada.
In Nov 2012, Kythera had reported positive interim results from a multicenter, open-label, long-term study on ATX-101. The study revealed that the candidate was well tolerated and demonstrated a similar safety profile to that observed in previous studies conducted with the candidate.
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