10xBio Announces the Completion of Phase 1B Clinical Trial of 10XB101
May 6, 2019
SAN DIEGO (May 6, 2019) – 10xBio, LLC, a privately-held biotechnology company, announced today that it has completed a Phase 1B study of its novel injectable drug product for body contouring. The company’s drug product 10XB101 is a novel formulation of polidocanol which is approved in the U.S. for vein sclerotherapy. 10xBio, LLC is repurposing the drug for body contouring applications in aesthetic medicine.
The study was conducted in patients scheduled for abdominoplasty with 10XB101 admistered 1 month prior to the tissue resection in escalating dose concentrations, number of injections, and volume of administration. Results demonstrated excellent safety with all local reactions related to the drug product rated as mild to moderate with resolution shortly after the drug administration and by the end of the study. There was minimal to no pain reported with the drug injection, and post-injection swelling and redness were predominantly mild and spontaneously resolved without treatment, most often within 24 hours. Although not anticipated given the design of this safety study, clinical evidence of fat atrophy was reported in the majority of patients in the two cohorts that received multiple injections. Histopathologic examination of tissue showed consistent fat destruction across the treatment area. The company has already initiated activities for a follow-on Phase 2 study for the treatment of sub-mental fat and expects testing to begin in the third quarter of 2019.
Mitch Goldman, M.D., a dermatologic surgeon and study investigator commented, “This study demonstrates the therapeutic potential of 10XB101 for body contouring. 10XB101 demonstrated minimal local side effects and pain, and may be administered in higher dosage volumes that could allow the treatment of more body areas for aesthetic contouring. 10XB101 may overcome the limitations of the currently marketed drug product for body contouring, Kybella, which exhibits significant pain and swelling side effects. ”
We are a biotechnology company that focuses on new uses for existing therapies and technologies. This strategy allows us to build on existing safety profiles and leverage known mechanisms of action, resulting in a streamlined development and regulatory process. Our most advanced asset, 10XB101, is a pharmaceutical product that addresses unmet needs in aesthetic medicine. For more information, visit us at www.10xBio.com.
John Dobak, M.D.