10xBio Announces the Completion of Enrollment In Phase 2b Clinical Trial of Novel Drug For Submental Body Contouring

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Summation

  • “I have been involved in the study of polidocanol for vein sclerotherapy for more than 40 years and am proud to lead the scientific and clinical effort to study this novel formulation of it for a new indication,” said Mitchel P.
  • 10xBio, LLC, a biotechnology company that focuses on new uses for existing therapies and technologies, announced today that it has completed enrollment in a repeat treatment study of its novel injectable drug for submental body contouring.
  • The drug, 10XB101, is a proprietary formulation of polidocanol, which is approved in the U.

10xBio, LLC, a biotechnology company that focuses on new uses for existing therapies and technologies, announced today that it has completed enrollment in a repeat treatment study of its novel injectable drug for submental body contouring. The drug, 10XB101, is a proprietary formulation of polidocanol, which is approved in the U.S. for vein sclerotherapy. 10xBio is repurposing polidocanol for body contouring applications in aesthetic medicine.

The global non-invasive fat removal market is estimated at $4BB, and is currently dominated by medical devices and just one U.S. marketed drug containing deoxycholate as the active pharmaceutical ingredient. 10XB101 is an innovative alternative, with the potential to offer benefits including enhanced patient tolerability, shorter treatment intervals and more.

“I have been involved in the study of polidocanol for vein sclerotherapy for more than 40 years and am proud to lead the scientific and clinical effort to study this novel formulation of it for a new indication,” said Mitchel P. Goldman, M.D., a dermatologic surgeon and medical director of Platinum and West Dermatology. “I believe that 10XB101 can achieve superior efficacy and tolerability than the currently marketed body contouring drug, deoxycholate, which I have more than 10 years of experience with. I look forward to seeing the results of this trial.”

A total of 51 patients are enrolled in this randomized, double-blind study across three treatment groups, including a placebo control group. Patients will receive multiple injections of 10XB101 in a predefined pattern, and can receive multiple treatments spaced one month apart. Efficacy will be assessed with a physician and patient submental fullness rating scale, measured 12 weeks after the patient’s final treatment. Tolerability will be assessed by recording local skin reactions on a four-point ordinal scale, including edema/swelling, pain, bruising, tenderness on palpation and erythema. The study is expected to be completed by the end of 2023.

In a previous study, 10XB101 showed excellent tolerability with minimal pain, swelling, bruising and erytherma. Patients and physicians reported improvements in a submental fullness rating scale after a single treatment.