Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in
redosable gene therapies for rare diseases, today announced the
launch of Jeune, Inc., a wholly owned subsidiary of Krystal
Biotech, and initial safety data from the ongoing Phase 1 trial of
Jeune’s lead product candidate, KB301 for treatment of aesthetic
skin conditions.
Jeune was formed to advance innovative aesthetic medicines and
has an exclusive license to a portfolio of candidates derived from
Krystal’s proprietary technology platform. Jeune’s products are
designed to directly address biological changes in the skin
associated with intrinsic and extrinsic aging. The lead product
candidate, KB301, delivers the human COL3A1 gene to increase
production of normal type III collagen at the site of
administration.
“My initial clinical experience with KB301 injections has been
highly encouraging,” said Dr. Mark Nestor, director of the Center
for Clinical and Cosmetic Research and the Center for Cosmetic
Enhancement. “Not only were the injections well-tolerated, but we
see clear signs of new collagen generation which underscores the
potential of this treatment to directly address the declining
levels of collagen that lead to wrinkles and other skin
changes.”
Initial data from Cohort 1 in the PEARL-1 studyThe Phase 1,
open-label, dose-ranging study is being conducted in adult subjects
aged 18-75 (NCT04540900). The primary outcome measure in this
first-in-human study was to assess the safety profile of KB301.
Secondary outcome measures include COL3A1 transgene expression. In
Cohort 1, three different dose levels of KB301 were evaluated in
seven (7) healthy subjects who received two intradermal injections
into healthy buttock tissue spaced 30 days apart (day 0, day 30).
KB301 injected areas were compared to uninjected or saline injected
control tissue within the same subject. Treatment and control sites
were biopsied at day 2 or day 32. Initial results are as
follows:
- Two repeated intradermal injections of KB301 were well
tolerated and no safety signals were observed
- Recorded adverse events were transient and limited to expected
mild or moderate injection site or biopsy site reactions (e.g.
erythema, site pain, purpura, ecchymosis)
- No vector shedding was detected in blood, urine, or skin swabs;
no meaningful changes in clinical labs were observed
- For all subjects who have completed follow up through day 90
(subjects 1-6; subject 7 follow up ongoing) no clinically
significant changes in anti-drug antibodies were observed
- qRT-PCR analysis of control and KB301-treated biopsies were
harvested 2-days post-dose, and show KB301-encoded COL3A1
expression at the mid and high dose, with no detectable expression
in control samples
- KB301-induced COL3A1 expression was evident by day 2 following
the first dose; expression levels were similar following the first
and second dose, underscoring the lack of immunogenicity to the
vector
More detailed data from Cohort 1 will be presented as an
e-Poster talk at the Society for Investigative Dermatology (SID)
Annual Meeting, held virtually May 3-8.
- Title: First‐in‐human safety and mechanism of
action (MOA) analyses of repeatedly dosed in vivo gene delivery for
directed human type III collagen (COL3) expression in
aesthetics
- Session Name: Poster Session I - Genetic
Disease, Gene Regulation, and Gene Therapy; 2:30pm – 4:00pm ET on
May 5th, 2021
The presentation will be available on-demand for those
registered for the SID conference from May 3, 2021 – May 31, 2021.
The poster will also be available on the company’s website at
www.jeuneinc.com
The company plans to begin enrollment in the efficacy cohorts of
the Phase 1 study in the second half of 2021.
Jeune, Inc. LeadershipJeune has assembled a veteran team of
leaders and advisors, comprised of pharmaceutical and biotechnology
executives who together have decades of experience developing
products in the aesthetic medicine space. Dr. Bhushan Hardas M.D.,
MBA will join the company on March 29th, 2021 as President of
Jeune. Before joining Jeune, Dr. Hardas served as Chief Scientific
Officer, Executive Vice President, Global Head of Licensing at
Almirall and previously served as Chief Medical Officer of
Allergan's Dermatology and Medical Aesthetics business.
“I am thrilled to be joining Jeune at such an exciting time.
With the ability to deliver genes directly to skin cells, this
platform has tremendous potential to address underlying biological
changes in aging or photo-damaged skin,” noted Dr. Hardas. “We are
starting with KB301 and type III collagen which I look forward to
advancing through the clinic, and the team is already working on
pipeline programs that will address additional proteins of
interest.”
Prior to joining Allergan, Dr. Hardas served as Senior Vice
President, Global Head of Dermatology and Aesthetics R&D and
Chief Scientific Officer of the North American Business at Merz
Pharmaceuticals. Dr. Hardas received advanced training in clinical
immunology and molecular biology at King's College at the
University of London, in London, England. He also completed a
research fellowship in the Department of Dermatology at the
University of Michigan, and received his Master of Business
Administration degree in healthcare management from the University
of California - Irvine.
“We are thrilled to welcome Bhushan to Jeune,” said Krish S.
Krishnan, chairman and chief executive officer of Krystal Biotech.
“His expertise and development experience in aesthetics is an
important asset presently and will help guide next steps for both
the pipeline and Jeune overall.”
Jeune, Inc. Board Krish Krishnan, Chairman and CEO at Krystal
Biotech will serve as the Chairman of the Jeune Board. Joining Mr.
Krishnan on the Board are Marc Forth, President and CEO of Aeon
BioPharma and Suma Krishnan, Founder and COO of Krystal
Biotech.
About Jeune Inc. Jeune Inc., a subsidiary
of Krystal Biotech, is a biotechnology company leveraging a
clinically validated gene-delivery platform to fundamentally
address – and reverse – the biology of aging and/or damaged skin.
For more information, please visit http://www.jeuneinc.com
About Krystal BiotechKrystal Biotech,
Inc. (NASDAQ:KRYS) is a pivotal-stage gene therapy company
leveraging its novel, redosable gene therapy platform and in-house
manufacturing capabilities to develop therapies to treat serious
rare diseases. For more information, please visit
http://www.krystalbio.com.
Forward-Looking StatementsAny statements in
this press release about future expectations, plans and prospects
for Krystal Biotech, Inc., or its subsidiary Jeune, Inc., including
but not limited to statements about the development of Krystal’s
and Jeune’s product candidates, such as plans for the design,
conduct and timelines of ongoing clinical trials of KB301 the
clinical utility of KB301, the ability of these candidates to
fundamentally address and potentially reverse the biology of aging
or damaged skin, plans to pursue research and development of other
product candidates; 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 or
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 views as of the date of this release. Krystal anticipates
that subsequent events and developments will cause its views to
change. However, while Krystal may elect to update these
forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as
representing Krystal’s views as of any date subsequent to the date
of this release.
CONTACTS:
Investors:Whitney Ijemwijem@krystalbio.com
Media:Mary CoyleTellMed
Strategiesmary.coyle@tmstrat.com
Source: Krystal Biotech, Inc.; Jeune, Inc.
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