- Krystal Biotech Inc's KRYS subsidiary Jeune Aesthetics Inc, announced nine-month durability of effect in the extension cohort of the PEARL-1 study of KB301 to address the underlying biology of aging skin for improvement of fine lines and wrinkles.
- Ten subjects from the PEARL-1 efficacy cohort were enrolled in the PEARL-1 extension cohort, an open-label study to assess the duration of effect below the zygomatic arch (the lower cheek area).
- The extension cohort enrolled subjects who had received the high dose regimen of KB301 during the efficacy cohort in one or both of their lower cheeks.
- Overall, data from the PEARL-1 extension cohort showed up to nine-month durability of effect following administration of high dose KB301.
- The mean change in Subject Satisfaction Scores from baseline ranged from 1.6 to 1.85 points approximately seven to nine months after dosing.
- In addition, Investigator Assessments for a clinically meaningful difference were also evaluated, with 70-76% of treated cheeks demonstrating a clinically meaningful difference approximately seven to nine months after KB301 dosing.
- All reported adverse events were injection site-related, and the reported events were transitory and rated as mild or moderate.
- Jeune is planning to initiate a Phase 2 study in 1H 2023 to assess the improvement of fine lines and wrinkles in challenging face areas.
- Price Action: KRYS shares closed lower by 1.81% at $75.81 on Wednesday.
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