Interim results of KYTHERA Biopharmaceuticals Inc‘s ATX-101 reaffirm the drug’s safety profile, the company reports. ATX-101 is a facial injectable drug for the reduction of submental fat.
Study participants received ATX-101 (2 mg/cm2) for up to six treatments spaced 28 days apart. The interim results included subjects who had completed Visit 9, or 3 months after last injection.
According to the findings, ATX-101 was 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. They included bruising, numbness, pain, swelling, redness, induration, itching, and nodule formation.
Although not designed to measure efficacy, the interim results 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.
Final study results will be analyzed following completion of the study, which is 12 months after last injection.
[Source: Kythera news release]