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Jeune Aesthetics Announces Positive Durability Results for KB301 in the PEARL-1 Extension Cohort, an Investigational Gene-based Treatment for Improvement of Fine Lines and Wrinkles
Up to nine months durability of effect observed in patients aged 55 to 76 in the extension cohort following administration of high dose KB301Mean change in
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"Up to nine months durability of effect observed in patients aged 55 to 76 in the extension cohort following administration of high dose KB301Mean change in Subject Satisfaction Scores from baseline ranged from 1.6 to 1.85 points up to nine months after dosingCompany plans on initiating a Phase 2 trial in fine lines and wrinkles in 1H 2023 PITTSBURGH, Nov. 17, 2022 (GLOBE NEWSWIRE) -- Jeune Aesthetics, Inc. (“Jeune”), a wholly owned subsidiary of Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS) today announced nine-month durability of effect in the extension cohort of the PEARL-1 study of KB301, an investigational gene-based treatment designed to address the underlying biology of aging skin for improvement of fine lines and wrinkles. “We are pleased to see the sustained durability of effect supporting the clinical benefits afforded by KB301,” said September Riharb, SVP of Jeune. “Treatment of superficial fine lines has been a challenge for aesthetic physicians, and as one of the first signs of skin aging, fine lines represent a significant unmet need. Replenishment of the skin’s key proteins through targeted gene-delivery holds promise for this significant market segment. We look forward to including a younger patient population in our future Phase 2 study.” About the PEARL-1 Durability Cohort Design Previously, the PEARL-1 study evaluated the safety, tolerability, and initial efficacy of intradermal dose-ranging injections of KB301 in adult subjects. Details of the Phase 1 study can be found at www.clinicaltrials.gov under NCT identifier NCT04540900. On March 22, 2022, Jeune announced positive proof-of-concept, safety and efficacy data with respect to improvement of fine lines and wrinkles in the upper cheek, lower cheek, and above the knee from the efficacy cohort of the PEARL-1 study. Ten subjects from the PEARL-1 efficacy cohort were enrolled in the PEARL-1 extension cohort, an open-label study to assess 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. Subject Satisfaction Scores and Investigator Assessments were measured monthly for three consecutive visits that correspond to timepoints up to nine-months following administration of the last dose of KB301. I...