10xBio Announces the Completion of Phase 2 Clinical Trial of 10XB101
August 3, 2021
SAN DIEGO (August 3, 2021) – 10xBio, LLC, a privately-held biotechnology company, announced today that it has completed a Phase 2 dose escalation 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 (n=3/group, 4 groups) with grade 3 or 4 submental fullness based on a submental fat rating scale. Patients received multiple injections of 0.2 ml of 10XB101, in a predefined pattern, with escalating concentrations of polidocanol. Patients received a single treatment and were followed for 24 weeks for local skin reactions, ECG and safety blood labs. Local skin reactions were assessed on a 4 point ordinal scale for pain/burning/stinging, edema, erythema, bruising, and tenderness on palpation. Changes in the submental fat rating rating scale by both the patient and clinician were assessed for preliminary efficacy findings.
All patients completed the study. There were zero serious adverse events. Ninety percent (90%) of local skin reactions were grade one and resolved within 2 weeks. There were no clinically significant changes on ECG and blood tests. After a single treatment, a dose dependent reduction in submental fat rating scale was observed by both patients and clinicians with mean grading changes ranging from 0.33 to 1.7. Changes in sub-mental fat grading were confirmed by photographic review of patients before and after treatment images.
John Dobak, M.D., Managing Director of 10xBio, LLC commented, “This study further confirms that 10XB101 demonstrates a better safety profile, with substantially less swelling and pain, than the currently marketed product Kybella. This study also demonstrate strong efficacy trends with approximately a one grade improvement in sub-mental fullness after a single treatment. We look forward to commencing a Phase 2b, multi-treatment study in the coming quarters.”
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.