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 PEARL-1 study showed the safety and tolerability of repeat KB301 injections. On March 22, 2022, Jeune announced positive proof-of-concept, safety and efficacy data with respect to improvement of fine lines and wrinkles from the efficacy cohort of the PEARL-1 study. On November 17, 2022, Jeune announced data from the PEARL-1 extension cohort showing up to nine-month durability of effect following administration of high dose KB301. Details of the Phase 1 study can be found at www.clinicaltrials.gov under NCT identifier NCT04540900.

About Jeune Aesthetics, Inc.

Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech, Inc., is a biotechnology company leveraging a clinically validated gene-delivery platform to fundamentally address – and reverse – the biology of aging skin. For more information, please visit http://www.jeuneinc.com.

About Krystal Biotech, Inc.

Krystal Biotech, Inc. (NASDAQ: KRYS) is a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases. The Company’s wide-ranging pipeline is based on its proprietary redosable HSV vector. Headquartered in Pittsburgh, Pennsylvania, the Company is led by an experienced management team, is fully-integrated and has core capabilities in viral vector design, vector optimization, gene therapy manufacturing and commercialization. For more information, please visit http://www.krystalbio.com, and follow @KrystalBiotech on LinkedIn and Twitter.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Krystal Biotech, Inc., or its wholly-owned subsidiary, Jeune Aesthetics, Inc., including but not limited to statements about Jeune’s pipeline of key skin proteins that it plans to advance through clinical development to create a new category of regenerative aesthetic medicine designed to address – and potentially reverse – biological changes in aging skin; the expectation that the Phase 1, Cohort 3 study will be to be completed in 2H 2023; Jeune’s plans to initiate a Phase 2 multicenter, double-blind randomized study of KB301 for the improvement of lateral canthal lines at rest; and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including KB301 and such other important factors as are set forth under the caption “Risk Factors” in Krystal’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Krystal’s and Jeune’s views as of the date of this release. Krystal and Jeune anticipate that subsequent events and developments will cause their views to change. However, while Krystal and Jeune may elect to update these forward-looking statements at some point in the future, they specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing Krystal’s and Jeune’s views as of any date subsequent to the date of this release.

CONTACT:

Investors and Media:
Meg Dodge
Krystal Biotech
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