- ATX-101 is an experimental injectable adipolytic agent for minimally invasive reduction of submental fat
- To date, Kythera Biopharmaceuticals has led seven clinical trials of ATX-101
- Average patient would require two to three treatments to acquire good cosmetic outcome
A novel injectable adipolytic agent is proving to be effective in the reduction of submental fat, representing a breakthrough in minimally invasive treatment approaches for this historically challenging-to-treat area.
ATX-101 (Kythera Biopharmaceuticals) is an experimental, first-in-class injectable adipolytic agent that can offer aesthetic patients a minimally invasive treatment option for the reduction of submental fat. Until now, only more invasive modalities such as surgery, ultrasound and other body contouring treatments have been used.
In a recently conducted double-blind, placebo-controlled, dose-ranging phase 2b clinical study, 129 patients were randomized to receive one of two dosing regimens of ATX-101 (1 mg/cm2 or 2 mg/cm2) or placebo. Treatments were administered monthly for up to five months in the submental area. Clinical assessments were performed at all treatment visits and at four and 12 weeks after the last treatment visit. Patient self-assessments and MRI assessments were performed at baseline, at treatment visit five and at 12 weeks after the last treatment visit.
STUDY RESULTS Results showed statistically significant reductions in submental fat in those patients treated with ATX-101 as compared with placebo, as assessed by all measures including clinician and patient-self assessments as well as MRI measurement for both fat volume and thickness. However, the 2 mg/cm2 dose proved to be the more efficacious dose and yielded a statistically significant reduction in submental fat compared to placebo, as measured by physician assessment and patient self-assessment.
A 30-year-old female clinical trial patient before (left, weight: 54 kg) and after (weight: 53 kg) treatment with ATX-101. Treatment resulted in a one-point improvement in severity of submental fat based on physician assessment using a five-point photonumeric rating scale (CR-SMFRS). (Photos credit: Kythera Biopharmaceuticals, phase 2 study, ATX-101-06-03)
"As an investigator, I was impressed with the results of the clinical trial and feel that this technology has proven effective so far," says Joel Schlessinger, M.D., a board-certified dermatologist and cosmetic surgeon; founder of Cosmetic Surgery Forum; and president of Advanced Skin Research Center, Omaha, Neb.
"Additionally, the concept of submental fat being treated with an adipolytic agent is intriguing to both myself and the clinical trial participants. We have also performed a market-based clinical concept study which confirmed a broad-based patient interest in this novel concept," he says.
According to Dr. Schlessinger, the main difference between an adipolytic agent such as ATX-101 and aesthetic devices used for this indication is the ease of administration and precision of its effect. The exciting aspect of ATX-101 is that aesthetic patients may no longer need to undergo ultrasound or laser procedures, or even surgery, he says.