Jeune Aesthetics Reports Positive Phase 1 Results for KB301 in Treating Wrinkles

Jeune Aesthetics, Inc., a subsidiary of Krystal Biotech, Inc., recently shared promising interim results from the PEARL-1 Phase 1 study. This research is examining KB301, an aesthetic treatment aimed at enhancing type III collagen (COL3) levels in the skin. The study's focus is on improving lateral canthal lines in Cohort 3 and dynamic wrinkles of the décolleté in Cohort 4.

KB301 is designed to rejuvenate aging skin by delivering the COL3A1 transgene. According to Steve G. Yoelin, M.D., one of the principal investigators, existing aesthetic treatments such as toxins and fillers only modify, rather than rejuvenate, aging skin. KB301, with its unique mechanism, could potentially alter the landscape of medical aesthetics by fundamentally replenishing the skin.

The study reported ongoing significant improvements in skin attributes for both cohorts. Investigators and subjects assessed these using the Global Aesthetic Improvement Scale (GAIS) and Subject Satisfaction Questionnaire (SSQ), noting sustained enhancements in the décolleté and lateral canthal regions.

For dynamic wrinkles of the décolleté, 20 subjects participated, with 18 completing the KB301 treatment. Results showed that at two months post-treatment, 94% of subjects experienced at least a one-point improvement, and 28% saw a two-point improvement on the GAIS scale. At one month, 83% had a one-point improvement, with 28% achieving a two-point improvement. Subject assessments mirrored these findings, with satisfaction rates increasing over two months. Additional skin attributes such as crepiness, hydration, and radiance also improved significantly, with 89%, 94%, and 94% of subjects reporting at least a one-point improvement, respectively.

Regarding lateral canthal lines, 13 subjects were enrolled, with 12 completing the treatment. Clinically meaningful improvements in wrinkles were observed, with 75% of subjects showing a one-point improvement and 50% showing a two-point improvement at two months. At one month, the improvement rates were 92% for one point and 50% for two points. Subjects' assessments paralleled these findings, with 67% reporting improved satisfaction with their wrinkle appearance. Other skin attributes also saw notable improvements, with at least 75% of subjects reporting better crepiness, hydration, and radiance two months post-treatment.

Safety data from both cohorts showed that KB301 was well-tolerated. Adverse events were mainly mild to moderate and transient, primarily related to the injection process, with no serious drug-related adverse events reported.

September Riharb, Senior Vice President of Jeune, expressed excitement over the significant aesthetic benefits observed, emphasizing KB301’s potential to rejuvenate skin by restoring youthful collagen levels. Based on these strong results, the company plans to advance KB301 into Phase 2 development for the treatment of dynamic wrinkles of the décolleté, an area currently lacking FDA-approved injectable treatments.

A subset of Cohort 4 subjects opted for redosing at the two-month follow-up, with ongoing data collection. Detailed results from PEARL-1 Cohorts 3 and 4 will be presented at future scientific conferences.

Jeune and Krystal will discuss the PEARL-1 interim results in a conference call and webcast, detailing the KB301 clinical development program and Jeune’s strategic vision. KB301 employs Krystal’s HSV-1-based vector to deliver the COL3A1 transgene, enhancing collagen levels to combat skin aging. The PEARL-1 study evaluates the safety, efficacy, and duration of KB301’s effects, building on positive results from previous cohorts.

Jeune Aesthetics leverages its gene-delivery platform to address aging skin biology fundamentally. Krystal Biotech focuses on developing genetic medicines for diseases with high unmet needs, with a robust pipeline across various medical fields.