Aesthetics
Jeune Aesthetics has announced the beginning of Dosing in the Efficacy Cohort of the KB301 Phase 1 Trial, which will evaluate the degree to which there has been an Improvement in Skin Quality.
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Intradermal administration of a full-length human type III collagen transgene is the intended method of administration for KB301.
It is anticipated that initial data from this efficacy cohort of the PEARL-1 study will be available in the fourth quarter of 21.
PITTSBURGH, Aug. 02, 2021 (GLOBE NEWSWIRE) — PEARL-1 is a Phase 1 multi-dose, controlled clinical study of KB301 to evaluate the improvement of skin quality. Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech, Inc., ("Krystal") (NASDAQ: KRYS), announced today that dosing has begun in the efficacy cohort of the PEARL-1 trial.
Dr. Bhushan Hardas, President of Jeune Aesthetics, made the observation that "the initiation of dosing in this cohort represents an important milestone for Jeune." [Citation needed] "While other modalities artificially address the symptoms of ageing skin or make use of controlled injury to indirectly stimulate collagen production, KB301 is designed to directly restore production of collagen," the researchers wrote. "[T]hese are the results you can expect to see after using KB301."
Changes that occur in the skin as a result of ageing are brought on by both intrinsic and extrinsic factors. Intrinsic factors include the passage of time and genetics, while extrinsic factors include chronic light exposure and pollution. These factors cause a gradual breakdown of dermal collagen and other extracellular matrix proteins, which in turn causes changes in the structure and appearance of the skin. The purpose of KB301 is to restore collagen locally by allowing cells to produce full-length human type III collagen (COL3A1), which will fundamentally address the biology of ageing skin. This will be accomplished by restoring collagen. The repeated administration of KB301 was found to be safe and well tolerated, according to the preliminary findings from the first cohort of the PEARL-1 study. The changes in skin roughness, fine lines, and skin thickness from baseline will be measured to determine whether or not there has been an improvement in the quality of the skin in Cohort 2.
Steve G. Yoelin, M.D., an ophthalmologist with a medical aesthetics private practice in Newport Beach, California, and a distinguished researcher, clinician, and speaker, said: "I am thrilled to be among the first to apply this innovative gene-delivery technology to aesthetics as part of the PEARL-1 study." The ability to generate normal collagen in a controlled manner has the potential to bring about a paradigm shift in the way skin quality is managed.
Regarding the PEARL-1 Clinical Trial
In Phase 1 dose-ranging trial, adult subjects ranging in age from 18 to 75 are receiving intradermal injections of KB301, and the trial is assessing the safety, tolerability, and initial efficacy of the treatment (NCT04540900). At the annual meeting of the Society for Investigative Dermatology (SID) in 2021, all of the results from the initial safety cohort were presented in their entirety.
Cohort 2 is a randomised, double-blind, saline-controlled trial to evaluate the safety and efficacy of KB301 for the improvement of skin quality attributes such as fine lines, texture, and skin thickness. The trial is being conducted in order to determine whether or not KB301 is effective in reducing the appearance of fine lines and wrinkles. Approximately thirty participants will be recruited for this cohort at two different research facilities. On Day 0, treatment areas will be chosen bilaterally on the neck behind the ear, on the cheek below and above the zygomatic arch, and around the knee. These areas will be randomised in a 2:1 fashion to receive either low-dose KB301, high-dose KB301, or saline. Multiple micro-depot injections, either with KB301 or with saline, will be administered all over the targeted treatment region.
The subjects will receive two treatments in the selected areas, each spaced out by two weeks, and the effectiveness of the treatments will be assessed two and four weeks after the subjects have received their final treatment. The Skin Roughness Score (SRS), the Fine Lines Score (FLS), and the Subject Satisfaction Score will be utilised in order to evaluate any changes in the subject's skin quality compared to the baseline (SSS). The difference in skin thickness knee will be measured with callipers specifically designed for the human skin.
Canfield Scientific's VISIA-CR, which includes micron resolution surface topography using the Primos 3D system and is now fully integrated into each set of captures, will also be used to measure the quality of the skin for this study. These captures will be made using Canfield Scientific's VISIA-CR. "We are very excited to objectively evaluate the measures for skin quality in this important study using our latest and most advanced facial imaging solution," said Doug Canfield, President of Canfield Scientific, Inc. "The findings of this study will have a significant impact on the dermatological community."
In the fourth quarter of 2021, researchers anticipate having preliminary findings from the PEARL-1 study's efficacy cohort.
About Jeune Aesthetics, Inc. (Jeune Aesthetics) Jeune Aesthetics, Inc. is a biotechnology company that is a subsidiary of Krystal Biotech. The company uses a gene-delivery platform that has been clinically validated in order to fundamentally address – and reverse – the biology of ageing and/or damaged skin. Please visit our website at jeuneinc.com for further information.
Introducing Yourself to Krystal Biotech, Inc.
Krystal Biotech, Inc., trading under the ticker symbol "KRYS," is a gene therapy company that is in the pivotal stage of its development. The company is developing therapies to treat serious rare diseases by utilising its novel, redosable gene therapy platform and in-house manufacturing capabilities. Please visit our website at krystalbio.com for further information.
Forward-Looking Statements
Any statements made in this press release about the 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 development of Jeune's product candidates, such as plans for the design, conduct, and timeliness of ongoing clinical trials of KB301, the clinical utility of KB301, the ability of KB301 to fundamentally address and potentially reverse the biology of aging or d Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors including, but not limited to: the uncertainties inherent in the initiation and conduct of clinical trials; the availability and timing of data from clinical trials; the question of whether the results of early clinical trials or trials will be indicative of the results of ongoing or future trials; and the uncertainties associated with regulatory review of clinical trials and applications. In addition, the forward-looking statements that are included in this press release represent Krystal's and Jeune's perspectives as of the date that this release was issued. Krystal is preparing for the possibility that its views will evolve as a result of subsequent events and developments. Nevertheless, despite the fact that Krystal may choose to revise these forward-looking statements at some point in the future, the company expressly 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. Instead, they should be interpreted as representing Krystal's views as of the date of this release.
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