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Jeune Aesthetics Announces Dosing of First Subject in Phase 1, Cohort 3 Study of KB301 for the Improvement of Lateral Canthal Lines at Rest
PITTSBURGH, April 18, 2023 (GLOBE NEWSWIRE) -- Jeune Aesthetics, Inc. (“Jeune”), a wholly-owned subsidiary of Krystal Biotech, Inc. (“Krystal”) (NASDAQ:
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[{"type":"text","content":"PITTSBURGH, April 18, 2023 (GLOBE NEWSWIRE) -- Jeune Aesthetics, Inc. (“Jeune”), a wholly-owned subsidiary of Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS), today announced treatment of the first subject in the Phase 1, Cohort 3 study of KB301 for the improvement of lateral canthal lines at rest. Jeune’s lead product candidate, KB301, delivers the human COL3A1 gene to targeted skin cells that in turn produce natural type 3 collagen. Natural collagen 3 is the first in a pipeline of key skin proteins that Jeune plans to advance through clinical development to create a new category of regenerative aesthetic medicines designed to address – and potentially reverse – biological changes in aging skin. The Phase 1, Cohort 3 study is being conducted at a single center as an open label study to evaluate two different doses of KB301 in up to 20 subjects. Improvement of lateral canthal lines at rest was selected as a target indication for KB301 based upon the Phase 1 safety, efficacy and durability studies, which evaluated KB301 in the lower and upper cheek, including the lateral canthal region. Subjects will be followed for three months after KB301 treatment, and the study is expected to be completed in 2H 2023. “We have systematically assessed the safety, efficacy and durability of KB301 in multiple skin areas and have narrowed down to a target indication where there are no FDA-approved injectable treatments,” said September Riharb, SVP of Jeune. “We plan to initiate a Phase 2 multicenter, double-blind randomized study of KB301 for the improvement of lateral canthal lines at rest following completion of the Phase 1 Cohort 3 study.” Currently, there are no FDA-approved injectable aesthetic drugs indicated for lateral canthal lines at rest. In addition, there are no aesthetic treatment options that address the core cause of aged skin in the lateral canthal region where the thin, delicate skin next to the eye is prone to fine lines and wrinkles. Compounding this issue is the fact that lateral canthal lines at rest are one of the most requested aesthetic treatments by adult subjects of all ages. About the Phase 1 Study Previously, the Phase 1, or PEARL-1, study evaluated the safety, tolerability, initial efficacy and duration of effect of intradermal dose-ranging injections of KB301 in adult subjects. Data from the safety cohort of the PEA...