Full Press Release Details
Krystal Biotech Announces Launch of Jeune, a Gene-Based Aesthetics Company, and Initial Phase 1 Safety
Data for KB301 in Aesthetic Indications
- Initial data from Cohort 1 of the PEARL-1 study
shows safety and tolerability of repeat KB301 injections
- Dr. Bhushan Hardas M.D., MBA appointed President, Jeune, Inc.
PITTSBURGH, March 24, 2021 Krystal Biotech Inc., ( Krystal ) (NASDAQ: KRYS), the leader in redosable gene
therapies for rare diseases today announced the launch of Juene, 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
Juene 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 noted. 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 study
The 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:
More detailed data from Cohort 1
will be presented as an e-Poster talk at the Society of Investigative Dermatology (SID) Annual Meeting, held virtually May 3-8.
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. Leadership
Jeune 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.
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.
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 Biotech
Krystal 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 Statements
Any 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 Jenue 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 includingKB301 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.
Source: Krystal Biotech, Inc.; Jeune,