[Edaily Reporter KIM SAE-MI ] Tego Science, Inc.(191420)announced on the 7th that it had confirmed the safety of “TPX-121,” a candidate treatment for facial wrinkles, in a Phase 1 clinical trial and observed its wrinkle-reducing effects.
TPX-121 is an autologous skin cell therapy derived from human skin cells and is being developed as a treatment for facial wrinkles.
This Phase 1 clinical trial was a single-center, single-arm study conducted at Kyungpook National University Hospital on adults requiring improvement of moderate-to-severe nasolabial folds. A total of 18 participants were enrolled across three dose groups: low, medium, and high.
According to the company, the clinical results showed no serious safety concerns in any of the dose groups. In the efficacy evaluation, all dose groups demonstrated an improvement rate of 50% or higher four weeks after administration. Twelve weeks later, the low-dose and high-dose groups recorded improvement rates of 66.7% and 50% or higher, respectively, while the medium-dose group also recorded an improvement rate of 50% or higher. The company explained that it confirmed a trend in which the therapeutic effect was maintained or increased up to 12 weeks.
TPX-121 received approval for its Phase 1 clinical trial application (IND) in July of last year. Tego Science, Inc. secured the results approximately six months after terminating the trial early in January of this year and plans to submit an IND application for a Phase 2/3 clinical trial this coming September.
Tego Science, Inc. official stated, “This is the world’s first wrinkle-improvement treatment made exclusively from human-derived cells—not synthetic compounds, toxic substances, cadaveric skin, or xenogeneic cells—and it has demonstrated both safety and efficacy in Phase 1,” adding, “We plan to accelerate the process with the goal of submitting the Phase 2/3 clinical trial application early and completing it swiftly.”