On the back of a $135 million public offering in February, rare disease gene therapy company Krystal Biotech has launched subsidiary Jeune Inc. to promote its gene therapies for aesthetic skin conditions.
On the back of a $135 million public offering in February, rare disease gene therapy company Krystal Biotech has launched subsidiary Jeune Inc. to promote its gene therapies for aesthetic skin conditions.
In conjunction with the launch, Jeune announced positive initial Phase I safety data for KB301, now its lead asset. The company said no safety signals or serious adverse events were observed in seven healthy subjects.
Jeune is planning to move KB301 efficacy cohorts later this year in patients with wrinkles and acne scars.
Several other companies–including Pittsburgh-based parent Krystal–are exploring gene therapies for more serious or life-threatening skin diseases like epidermolysis bullosa. Krystal, Castle Creek Biosciences, and Abeona Therapeutics all have gene therapies delivering the COL7A1 gene in Phase III testing for patients with dystrophic epidermolysis bullosa (EB).
Defective COL7A1 prevents healthy production of type VII collagen in these patients, and severe dystrophic EB can be fatal. Castle Creek and Abeona are testing their therapies in patients with the more severe recessive dystrophic EB, while Krystal’s B-VEC is in patients with either recessive or dominant forms.
But Jeune’s KB301 delivers a full-length COL3A1 gene to promote type III collagen synthesis, which is reduced in aged skin. Like Krystal’s other gene therapies in development, KB301 is delivered via an HSV-1 vector, which the company says makes the therapies redosable, if needed.
The PEARL-1 trial, launched last August, is an open-label study enrolling adults up to 75 years old, and the efficacy arms will enroll up to 22 patients with either shallow-to-moderately deep facial wrinkles or moderate-to-severe atrophic acne scars. In the safety arm, transient adverse events were limited to mild-to-moderate injection or biopsy site reactions. The company plans to present additional data during a virtual poster presentation at the Society for Investigative Dermatology (SID) Annual Meeting in May.
Although Jeune is focused on aesthetic skin conditions, the U.S. Food and Drug Administration (FDA) has said that a product designed to remove wrinkles or increase skin collagen production in the skin would be regulated as a drug. There are no other known clinical trials ongoing for a type III collagen-based therapy.
Bhusan Hardas, an industry veteran who was previously chief medical officer of Allergan’s Dermatology and Medical Aesthetics business, will begin as president of Jeune later this month.
Jeune is a wholly-owned subsidiary of Krystal. No financial details about Jeune have been disclosed.
