Jeune Aesthetics, Inc. (“Jeune”), a wholly owned subsidiary of
Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS) leveraging
Krystal’s clinically validated gene-delivery platform to
fundamentally address – and reverse – the biology of aging skin,
announced today positive interim safety and efficacy results from
both Cohorts 3 and 4 of PEARL-1, a Phase 1 study evaluating KB301,
an investigational aesthetic treatment designed to deliver the
COL3A1 transgene and increase type III collagen (“COL3”) levels in
the skin, for the improvement of lateral canthal lines at rest in
Cohort 3 and for the improvement of dynamic wrinkles of the
décolleté in Cohort 4.
“Today’s injectable aesthetics toolbox is limited to toxins and
fillers which allow us to manipulate, but not rejuvenate, aging
skin,” said Steve G. Yoelin, M.D., one of the principal
investigators for PEARL-1. “With its unique mechanism of action and
compelling early efficacy data, I am excited by the potential for
KB301 to change the treatment paradigm in the field of medical
aesthetics and meet the growing demand for treatments that
fundamentally replenish the skin or delay signs of aging.”
Meaningful and sustained improvements in skin aesthetic
attributes, assessed using a Global Aesthetic Improvement Scale
(“GAIS”), were reported by the study investigators and subjects
alike in both the décolleté and lateral canthal regions. Increased
subject satisfaction with wrinkle appearance was also reported
using a Subject Satisfaction Questionnaire (“SSQ”).
Dynamic Wrinkles of the Décolleté Topline Efficacy
Results
A total of 20 subjects were enrolled. Two subjects dropped out
before completing KB301 treatments. The remaining 18 subjects were
assessed for aesthetic improvement out to two months following
KB301 injections in the décolleté region. Results included:
- Study investigators reported clinically meaningful improvement
in wrinkles both one and two months after treatment, as assessed by
GAIS:
- At two months: 94% of subjects had at least a one point
improvement and 28% had a two point improvement - the maximum
potential score on the GAIS scale.
- At one month: 83% of subjects had at least a one point
improvement and 28% had a two point improvement.
- Subjects also reported improvements in wrinkles that increased
from the first to second follow up month, as assessed by GAIS:
- At two months: 89% of subjects reported at least a one point
improvement and 39% reported a two point improvement.
- At one month: 61% of subjects reported at least a one point
improvement and 28% reported a two point improvement.
- 94% of subjects reported improved satisfaction with their
wrinkles’ appearance two months after treatment, as assessed by
SSQ.
- Improvements were also seen across multiple additional skin
attributes, as assessed by GAIS, including crepiness, hydration,
and radiance, for which investigators reported improvements of 1
point or better in 89%, 94%, and 94% of subjects, respectively, two
months after treatment.
Lateral Canthal Line Topline Efficacy
Results
A total of 13 subjects were enrolled. One subject dropped out
before completing KB301 treatments. The remaining 12 subjects were
assessed for aesthetic improvement out to two months following
KB301 injections in the lateral canthal region. Results
included:
- Study investigators again reported clinically meaningful
improvement in wrinkles both one and two months after treatment, as
assessed by GAIS:
- At two months: 75% of subjects had at least a one point
improvement and 50% had a two point improvement.
- At one month: 92% of subjects had at least a one point
improvement and 50% had a two point improvement.
- Subjects also reported improvements in wrinkles, as assessed by
GAIS:
- At two months: 50% of subjects reported at least a one point
improvement and 25% reported a two point improvement.
- At one month: 58% of subjects reported at least a one point
improvement and 17% reported a two point improvement.
- 67% of subjects reported improved satisfaction with their
wrinkles’ appearance two months after treatment, as assessed by
SSQ.
- Improvements across multiple additional skin attributes were
again reported, as assessed by GAIS, with investigators reporting
one point or greater improvements in at least 75% of subjects for
each of crepiness, hydration, and radiance, two months following
treatment.
Across both cohorts, the KB301 safety profile was consistent
with prior clinical experience in Cohorts 1 and 2 and other
injectable aesthetic products. Adverse events were primarily
injection associated, mild-to-moderate, and transient. No drug
related serious adverse events were reported.
“We are excited to share today’s data update in which we
continue to see profound aesthetic benefits following KB301
administration in both the lateral canthal region and the
décolleté, in line with our earlier findings from PEARL-1 Cohort
2,” said September Riharb, Senior Vice President of Jeune. “We are
also pleased that, in addition to reporting improvements in fine
lines and wrinkles, both study investigators and subjects alike
reported high rates of improvement across a variety of key skin
attributes, consistent with KB301’s paradigm-changing mechanism of
delivering COL3A1 directly to the skin and restoring COL3 levels to
more youthful levels. The natural looking results of KB301
rejuvenated skin are exactly what consumers are looking for today.
On the basis of the strong results we saw in Cohort 4, we will be
progressing KB301 into Phase 2 development for the treatment of
dynamic wrinkles of the décolleté, a priority aesthetic site for
which no FDA-approved injectables exist, and will be meeting with
the FDA in the coming months to enable initiation of the Phase 2
study.”
A subset of Cohort 4 subjects opted in to redose at the two
month follow up timepoint, after completing the assessments
described above. Additional data collection is ongoing in the
redosed subjects. Upon completion, detailed results of PEARL-1
Cohorts 3 and 4 will be presented at future scientific
conference(s).
Conference Call, Webcast and Presentation
Information
Jeune and Krystal will host a conference call and webcast today,
Wednesday, August 28, 2024, at 4:30 pm ET, to discuss the PEARL-1
Cohort 3 and Cohort 4 interim results, the KB301 clinical
development program, Jeune’s pipeline product candidates, and the
strategic vision for Jeune.
Investors and the general public can access the live webcast at:
https://www.webcaster4.com/Webcast/Page/3018/51166
For those unable to listen to the live webcast, a replay will be
available on the Investor’s section of the Krystal website at
www.krystalbio.com.
About KB301 KB301 is an investigational
aesthetic therapy employing Krystal’s novel replication-defective,
non-integrating HSV-1-based vector to deliver two copies of the
COL3A1 transgene and increase COL3 levels in skin to address signs
of skin aging associated with declining collagen levels and damage
of the skin’s extracellular matrix. KB301 is formulated as a
solution for direct intradermal injection to aesthetic priority
areas.
About the PEARL-1 StudyPEARL-1 is a
multi-cohort Phase 1 study designed to evaluate the safety,
tolerability, initial efficacy and duration of effect of
intradermal KB301 injections in adult subjects. Previously
disclosed results from Cohorts 1 and 2 revealed that repeat
administration of KB301 to various locations on the body was
well-tolerated and, in 2022, Jeune announced positive
proof-of-concept, safety, efficacy, and nine-month durability data
from PEARL-1 Cohort 2 with respect to improvement of fine lines and
wrinkles. Building on the results from Cohort 2, Cohorts 3 and 4 of
PEARL-1 are open-label, single-arm cohorts designed to evaluate
KB301 in two potential target indications for Phase 2, lateral
canthal lines at rest and dynamic wrinkles of the décolleté.
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 commercial-stage biotechnology company
focused on the discovery, development and commercialization of
genetic medicines to treat diseases with high unmet medical needs.
VYJUVEK® is the Company’s first commercial product, the first-ever
redosable gene therapy, and the first medicine approved by the FDA
for the treatment of dystrophic epidermolysis bullosa. The Company
is rapidly advancing a robust preclinical and clinical pipeline of
investigational genetic medicines in respiratory, oncology,
dermatology, ophthalmology, and aesthetics. Krystal Biotech is
headquartered in Pittsburgh, Pennsylvania. For more information,
please visit http://www.krystalbio.com, and follow @KrystalBiotech
on LinkedIn and X (formerly Twitter).
Forward-Looking StatementsAny statements in
this press release about future expectations, plans and prospects
for Krystal Biotech, Inc., or its wholly-owned subsidiary,
Jeune Aesthetics, Inc., including statements about the clinical
utility of KB301; the potential for KB301 to change the treatment
paradigm in the field of medical aesthetics and meet the growing
demand for treatments that fundamentally replenish the skin or
delay signs of aging; Krystal’s and Jeune’s plans to progress KB301
into Phase 2 development for the treatment of dynamic wrinkles of
the décolleté, including timing of meeting with the FDA and the
initiation of the Phase 2 study; Krystal’s proprietary, HSV-1 based
gene delivery platform; 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: uncertainties associated with regulatory review
of clinical trials, the availability or commercial potential of
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 press
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 press release.
CONTACTInvestors and Media:
Stéphane Paquette, PhD
Krystal Biotech
spaquette@krystalbio.com
Krystal Biotech (NASDAQ:KRYS)
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