KYTHERA Biopharmaceuticals, Inc. 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.
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