Krystal Biotech, a company that develops gene therapies, has launched a new, aesthetics-focused subsidiary, called Jeune, and released initial safety data from the ongoing Phase 1 trial of its product, KB301, for treatment of cosmetic skin concerns.
KB301 delivers the human COL3A1 gene to increase production of normal type III collagen at the site of administration. Initial data from Cohort 1 in the PEARL-1, a phase 1, open-label, dose-ranging study of KB301 in adult subjects aged 18-75 (NCT04540900) shows:
- Two repeated intradermal injections of KB301 were well tolerated and no safety signals were observed
- Recorded adverse events were transient and limited to expected mild or moderate injection site or biopsy site reactions (e.g. erythema, site pain, purpura, ecchymosis)
- No vector shedding was detected in blood, urine, or skin swabs; no meaningful changes in clinical labs were observed
- For all subjects who have completed follow up through day 90 (subjects 1-6; subject 7 follow up ongoing) no clinically significant changes in anti-drug antibodies were observed
- qRT-PCR analysis of control and KB301-treated biopsies were harvested two days post-dose, and show KB301-encoded COL3A1 expression at the mid and high dose, with no detectable expression in control samples
- KB301-induced COL3A1 expression was evident by day 2 following the first dose; expression levels were similar following the first and second dose, underscoring the lack of immunogenicity to the vector
“My initial clinical experience with KB301 injections has been highly encouraging,” said Mark Nestor, MD, PhD, 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.”
As a result of the positive clinical trial results, Jeune compiled a team of leaders and advisors, with a new president to further develop and eventually commercialize that drug.
Bhushan Hardas MD, MBA, has been appointed president. He previously served as chief scientific officer, executive vice president and global head of licensing at Almirall and chief medical officer of Allergan's Dermatology and Medical Aesthetics business.