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 KB301
- Mean change in Subject Satisfaction Scores from baseline ranged from 1.6 to 1.85 points up to nine months after dosing
- Company plans on initiating a Phase 2 trial in fine lines and wrinkles in 1H 2023
“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. In addition, subjects with placebo-treated lower cheeks were dosed with KB301 during the open-label extension cohort to normalize their appearance.
About the PEARL-1 Extension Cohort Results
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. Alternatively, a responder analysis based on Subject Satisfaction Scores was performed. The percentage of responders, defined as a lower cheek with a Subject Satisfaction Score of ≥1 point change from baseline, ranged from 62% to 70%.
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 associated with the extension cohort KB301 treatment to the placebo treated lower cheeks, to normalize the subjects’ appearance, were injection site-related and the reported events were transitory and rated as mild or moderate.
Next Steps, Initiation of the PEARL-2 Study
Based on the positive results from the PEARL-1 study and feedback from the
Investor Conference Call, Webcast and Presentation Information
Jeune and Krystal will host a 30-minute investor conference call and webcast today,
For those unable to listen to the live conference call, a replay will be available on the Investor’s section of the Krystal website at www.krystalbio.com.
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Source: Krystal Biotech, Inc.