Jeune Aesthetics Announces Dosing of First Subject in Phase 1, Cohort 3 Study of KB301 for the Improvement of Lateral Canthal Lines at Rest
April 18 2023 - 6:00AM
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 DodgeKrystal
Biotechmdodge@krystalbio.com
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