Tego Science has successfully demonstrated efficacy in a phase 3 clinical trial of its cell therapy for under-eye wrinkles, fulfilling the conditions for a full license. Tego Sscience's stock price surged to a daily permissible limit on Tuesday.
Tego Science released the results of the domestic phase 3 clinical trial of Rosmir (TPX-105) through a public filing on the day. Rosmir is a self-derived cell therapy indicated for moderate to severe nasojugal grooves.
Tego Science conducted the phase 3 trial of Rosmir in about 60 adults with under-eye wrinkles at Kyungpook National University Hospital, Seoul St. Mary's Hospital, Korea University Guro Hospital, and Soon Chun Hyang University Bucheon Hospital for two years from 2021 to 2023, demonstrating an improvement in skin wrinkles compared to placebo.
Adults with under-eye wrinkle severity grade 3 or higher who wanted correction were recruited in a 2:1 ratio between the test and control groups (placebo) and evaluated up to 48 weeks after administration. Clinical results showed an improvement in under-eye furrow severity as assessed by an independent assessor at 24 weeks of 66.67 percent in the treatment group and 5.26 percent in the control group, resulting in a between-group difference in under-eye wrinkle improvement of 61.40 percent (95 percent CI: [43.52, 79.28]).
The statistically significant difference between the groups (p<0.0001) confirmed the superiority of TPX-105 in improving the severity of nasolabial furrows compared to the control group, the company said.
Tego Science plans to submit the clinical study result (CSR) to the Ministry of Food and Drug Safety (MFDS). The company received the MFDS approval to manufacture and sell Rosmir after completing the phase 2 trial on the condition of conducting phase 3. It is supplying the product to major plastic surgery clinics and university hospitals.
If the MFDS grants the permit based on the phase 3 data, Rosmir will be Korea's first and only cell therapy approved for treating wrinkles. It also has the characteristics of a self-derived cell therapy administered topically to the skin.
"Overseas, clinical trials of a rival drug targeting this indication have failed," a company official said. "Despite many variables, including the Covid-19 pandemic during the clinical trial period, we could submit the phase 3 clinical trial report for Rosmir within the specified deadline through close consultation with the MFDS."
The official added that the phase 3 data confirms the superior wrinkle reduction efficacy of Rosmir, and the company will continue to work hard to expand the market.
The news of the phase 3 success of Rosmir sent Tego Science’s stocks soaring to a daily permissible limit. Its share price closed at 11,150 won ($8.57) on Tuesdsay, up 29.96 percent from the previous day.