10xBio, LLC, a biotechnology company that focuses on new uses for existing therapies and technologies, announced today promising initial clinical trial results on its novel injectable drug for submental body contouring, 10XB101. An innovative alternative to other fat removal options, 10XB101 provides superior efficacy, fewer side effects, enhanced patient tolerability and shorter treatment intervals.
In this randomized, double-blind, placebo-controlled study with three active treatment groups, patients received multiple injections of 10XB101 in a predefined pattern, with up to six treatments spaced four weeks apart. Efficacy was assessed by clinician- and patient-based assessments (CSFS and PSFS) using a submental fat rating scale by comparing Baseline to outcomes four weeks after their last treatment.
“The results of this study clearly demonstrated far superior efficacy and tolerability for 10XB101 than the currently marketed body contouring drug, deoxycholate, which I have more than 10 years of experience with,” said Mitchel P. Goldman, M.D., a dermatologic surgeon and medical director of Cosmetic Laser Dermatology. “10XB101 has the appropriate product-market fit to capture the tremendous opportunity for submental contouring. In addition, its attributes hold promise for potential expansion to other body contouring applications, such as treatment of the abdomen and flanks.”
Key findings include:
- In the intent to treat (ITT) population, more than 50% of patients in the two higher dose groups achieved a concordant Grade 2 or more improvement in both their CSFS and PSFS scores, the FDA designated primary endpoint, compared to 0% in the placebo group.
- In the completer population (e.g. patients receiving at least four doses of 10XB101), about 80% of patients in the two higher dose active groups demonstrated concordant Grade 2 or more improvement in both their CSFS and PSFS scores, compared to 0% in the placebo group.
- Onset of effect was rapid in the higher dose groups with more than 65% of ITT and more than 84% of completer populations achieving a minimum of a Grade 1 improvement or greater after their initial two treatment sessions.
- Local injection site reactions were measured using a four-point scale ranging from absent to severe and included bruising, edema, pain and erythema at each visit during the trial. About 98% of injection site reactions were measured as zero (absent) or one (mild).
The results compare favorably to deoxycholate, the only marketed drug for non-invasive fat removal in the U.S., with up to four times as many patients achieving concordant Grade 2 or more improvement on the CSFS/PSFS. With 10XB101, the frequency and severity of injection site reactions are meaningfully lower than with its counterpart.
Kavita Darji, MD, FAAD, a fellowship trained cosmetic dermatologic surgeon, presented this data at the 2024 American Academy of Dermatology (AAD) Annual Meeting on March 9, with an opportunity for attendees to ask questions.
10xBio is seeking licensing partners in the US, Europe and select territories worldwide. For more information on the company, please visit https://10xbio.com/.
About 10xBio: 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.
SOURCE 10xBio
