Jeune Aesthetics, Inc. (“Jeune”), a wholly owned subsidiary of
Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS) today announced
nine-month durability of effect in the extension cohort of the
PEARL-1 study of KB301, an investigational gene-based treatment
designed to address the underlying biology of aging skin for
improvement of fine lines and wrinkles.
“We are pleased to see the sustained durability of effect
supporting the clinical benefits afforded by KB301,” said September
Riharb, SVP of Jeune. “Treatment of superficial fine lines has been
a challenge for aesthetic physicians, and as one of the first signs
of skin aging, fine lines represent a significant unmet need.
Replenishment of the skin’s key proteins through targeted
gene-delivery holds promise for this significant market segment. We
look forward to including a younger patient population in our
future Phase 2 study.”
About the PEARL-1 Durability Cohort Design
Previously, the PEARL-1 study evaluated the safety,
tolerability, and initial efficacy of intradermal dose-ranging
injections of KB301 in adult subjects. Details of the Phase 1 study
can be found at www.clinicaltrials.gov under NCT
identifier NCT04540900. On March 22, 2022, Jeune
announced positive proof-of-concept, safety and efficacy data
with respect to improvement of fine lines and wrinkles in the upper
cheek, lower cheek, and above the knee from the efficacy cohort of
the PEARL-1 study.
Ten subjects from the PEARL-1 efficacy cohort were enrolled in
the PEARL-1 extension cohort, an open-label study to assess
duration of effect below the zygomatic arch (the lower cheek area).
The extension cohort enrolled subjects who had received the high
dose regimen of KB301 during the efficacy cohort in one or both of
their lower cheeks. Subject Satisfaction Scores and Investigator
Assessments were measured monthly for three consecutive visits that
correspond to timepoints up to nine-months following administration
of the last dose of KB301. In addition, subjects with
placebo-treated lower cheeks were dosed with KB301 during the
open-label extension cohort to normalize their appearance.
About the PEARL-1 Extension Cohort Results
Overall, data from the PEARL-1 extension cohort showed up to
nine-month durability of effect following administration of high
dose KB301. The mean change in Subject Satisfaction Scores from
baseline ranged from 1.6 to 1.85 points approximately seven to nine
months after dosing. Alternatively, a responder analysis based on
Subject Satisfaction Scores was performed. The percentage of
responders, defined as a lower cheek with a Subject Satisfaction
Score of ≥1 point change from baseline, ranged from 62% to 70%.
In addition, Investigator Assessments for a clinically
meaningful difference were also evaluated with 70-76% of treated
cheeks demonstrating a clinically meaningful difference
approximately seven to nine months after KB301 dosing.
All reported adverse events associated with the extension cohort
KB301 treatment to the placebo treated lower cheeks, to normalize
the subjects’ appearance, were injection site-related and the
reported events were transitory and rated as mild or moderate.
Next Steps, Initiation of the PEARL-2 Study
Based on the positive results from the PEARL-1 study and
feedback from the U.S. Food and Drug Administration on newly
developed internal scales, Jeune is planning to initiate a Phase 2
study in 1H 2023. The Phase 2 study, called the PEARL-2 study, will
be a prospective, multicenter, randomized, double-blind,
placebo-controlled study to assess improvement of fine lines and
wrinkles in challenging areas of the face.
Investor Conference Call, Webcast and Presentation
Information
Jeune and Krystal will host a 30-minute investor conference call
and webcast today, Thursday, November 17, at 8:30 am ET, to discuss
the PEARL-1 extension cohort results and the KB301 clinical
development program. To register and participate in the conference
call, please go to:
https://www.netroadshow.com/events/login?show=644d1cca&confId=44638.
For those unable to listen to the live conference call, a replay
will be available on the Investor’s section of the Krystal website
at www.krystalbio.com.
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 the clinical utility of KB301, Jeune’s plan to
initiate a Phase 2 study of KB301 in 1H 2023, 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
Source: Krystal Biotech, Inc.
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