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KYTHERA Reports Results from Open-Label Study for ATX-101

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CORRECTION: Kythera Reports FDA Acceptance of ATX-101 NDA, PDUFA Date Set at May 13, 2015
Kythera Reports FDA Acceptance of ATX-101 NDA, PDUFA Date Set at May 13, 2015

KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today announced interim study results from Study ATX-101-11-26, a multicenter, open-label, long-term study to evaluate the safety of ATX-101, a facial injectable drug for the reduction of submental fat (SMF), which commonly presents as an unwanted double chin.

This study captured subjects who received ATX-101 (2 mg/cm^2) for up to six treatments spaced 28 days apart. The interim results included subjects who had completed Visit 9, or three months after last injection, which is the same study endpoint as the ongoing U.S. and Canadian Phase III pivotal trials. Final study results will be analyzed following completion of the study, which is 12 months after last injection.

In this study, ATX-101 was found to be well tolerated and the observed overall safety profile was consistent with findings from previous Phase II and European Phase III clinical trials. Adverse events were mostly mild to moderate, and transient. The most common adverse events were bruising, numbness, pain, swelling, redness, induration, itching and nodule formation. These adverse events were limited to the injection site and were temporally associated with treatment.

Although not designed to measure efficacy, the interim results from this open-label Study 26 were also consistent with the efficacy results observed in previous studies of similar design. Mean changes from baseline in submental fat measured 12 weeks after last injection were -1.3 on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and -1.2 on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS). Additionally, 71.3% of subjects had at least a 1-grade improvement on the CR-SMFRS / PR-SMFRS composite and 14.0% had at least a 2-grade improvement on the same composite measure.

KYTHERA currently expects to submit additional details from this study for presentation at a future medical meeting.

Posted-In: News FDA

 

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