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Krystal Biotech Announces Launch of Jeune, a Gene-Based Aesthetics Company, and Initial Phase 1 Safety Data for KB301 in Aesthetic Indications
- Initial data from Cohort 1 of the PEARL-1 study shows safety and tolerability of repeat KB301 injections - Dr. Bhushan Hardas M.D., MBA appointed President,
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"- Initial data from Cohort 1 of the PEARL-1 study shows safety and tolerability of repeat KB301 injections - Dr. Bhushan Hardas M.D., MBA appointed President, Jeune, Inc. PITTSBURGH, March 24, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced the launch of Jeune, Inc., a wholly owned subsidiary of Krystal Biotech, and initial safety data from the ongoing Phase 1 trial of Jeune’s lead product candidate, KB301 for treatment of aesthetic skin conditions. Jeune was formed to advance innovative aesthetic medicines and has an exclusive license to a portfolio of candidates derived from Krystal’s proprietary technology platform. Jeune’s products are designed to directly address biological changes in the skin associated with intrinsic and extrinsic aging. The lead product candidate, KB301, delivers the human COL3A1 gene to increase production of normal type III collagen at the site of administration. “My initial clinical experience with KB301 injections has been highly encouraging,” said Dr. Mark Nestor, director of the Center for Clinical and Cosmetic Research and the Center for Cosmetic Enhancement. “Not only were the injections well-tolerated, but we see clear signs of new collagen generation which underscores the potential of this treatment to directly address the declining levels of collagen that lead to wrinkles and other skin changes.” Initial data from Cohort 1 in the PEARL-1 studyThe Phase 1, open-label, dose-ranging study is being conducted in adult subjects aged 18-75 (NCT04540900). The primary outcome measure in this first-in-human study was to assess the safety profile of KB301. Secondary outcome measures include COL3A1 transgene expression. In Cohort 1, three different dose levels of KB301 were evaluated in seven (7) healthy subjects who received two intradermal injections into healthy buttock tissue spaced 30 days apart (day 0, day 30). KB301 injected areas were compared to uninjected or saline injected control tissue within the same subject. Treatment and control sites were biopsied at day 2 or day 32. Initial results are as follows: Two repeated intradermal injections of KB301 were well tolerated and no safety signals were observedRecorded adverse events were transient and limited to expected mild or moderate injection site...