Drug a potential noninvasive treatment to remove fat from under neck

Key takeaways:

• An injectable drug for submental body contouring, 10XB101, is now in a phase 2b study.
• The study’s lead author believes it is “safer and more effective” than the only other FDA-approved injectable.

An injectable drug currently approved to treat varicose veins is having its safety and efficacy tested in a phase 2b study to evaluate its potential as a treatment option for noninvasive fat removal under the neck.

The study’s lead author, Mitchel P. Goldman, MD, told Healio that participants have completed their 3-month follow-up visits after being treated with 10XB101, a proprietary reformulation of polidocanol developed by 10xBio LLC. The participants will be evaluated again in another 3 months for their 6-month follow-up visit.

Goldman believes 10XB101 will prove “safer and more effective” than the only injectable currently FDA-approved for submental fat removal, Kybella (deoxycholic acid, Allergan). There is almost no pain with 10XB101 injections, according to Goldman, as well as considerably less swelling than with the established drug.

Mitchel P. Goldman

“Physicians would most likely choose the least painful ... more efficacious product, which would be polidocanol, or the 10XB101,” Goldman said. “In my mind, that is going to replace the Kybella.”

The double-blind phase 2b study randomly assigned 51 patients into two treatment arms and a placebo control group, according to a press release from 10xBio. It is expected to be completed by the end of 2023.

Participants can be injected with 10XB101 multiple times, with efficacy assessed 12 weeks after final treatment using a physician and patient submental fullness rating scale. Tolerability will be evaluated by recording local skin reactions — including pain, bruising, erythema, edema/swelling and tenderness on palpation — on a 4-point ordinal scale.

A phase 2 study of 10XB101 conducted in 2021 resulted in no serious adverse events across 12 participants, with patients and clinicians reporting dose-dependent reductions in submental fat ratings, according to a press release.

References:

• What is KYBELLA? https://www.mykybella.com/what-is-kybella. Accessed Aug. 21, 2023.
• 10xBio announces the completion of phase 2 clinical trial of 10XB101. https://10xbio.com/press-releases/10xbio-announces-the-completion-of-phase-2-clinical-trial-of-10xb101/. Published Aug. 3, 2021. Accessed Aug. 21, 2023.