Jeune Aesthetics Announces Phase 1 Positive Interim Safety and Efficacy Results for KB301
On August 28, 2024, Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech (KRYS) announced 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 the improvement of dynamic wrinkles of the décolleté in Cohort 4.
From the Experts
Steve G. Yoelin, M.D., one of the principal investigators for PEARL-1, said, “Today’s injectable aesthetics toolbox is limited to toxins and fillers which allow us to manipulate, but not rejuvenate, aging skin 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.”
Reported Increase Subject Satisfaction About Wrinkles Appearance
The study investigators and subjects reported meaningful and sustained improvements in skin aesthetic attributes, assessed using a Global Aesthetic Improvement Scale (“GAIS”), 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 for 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.
- In 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 creepiness, 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 for 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 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.
From Jeune Aesthetics
Senior Vice President of Jeune said, “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. 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. Based on 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 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 conferences.
Conference Call, Webcast, and Presentation Information have been hosted on August 28, 2024. For those unable to listen to the live webcast, a replay is 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 Study
PEARL-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 concerning 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.
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.
About Krystal Biotech, Inc.
Krystal Biotech 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.
Please read Forward-Looking Statements
Prohost Observations
We are also excited to see profound aesthetic benefits following KB301 administration in both the lateral canthal region and the décolleté. We are also pleased to hear about reported high rates of improvement across several various key skin qualities the restoration of COL3 levels to more youthful levels and the natural-looking results of KB301 rejuvenated skin, which consumers are looking for today. The strong results in Cohort 4 enable the progression of KB301 into Phase 2 development for the treatment of wrinkles of the décolleté, a priority aesthetic site for which no FDA-approved injectables exist. The firm will be meeting with the FDA to enable the initiation of the Phase 2 study.
Click here to read more about Jeune Aesthetics.
Click here to read more about Krystal Biotech.
News & Comments
September 4, 2024
Jeune Aesthetics: Reversing the Biology of Aging Skin to Meet the Growing Demand
Jeune Aesthetics Announces Phase 1 Positive Interim Safety and Efficacy Results for KB301
On August 28, 2024, Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech (KRYS) announced 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 the improvement of dynamic wrinkles of the décolleté in Cohort 4.
From the Experts
Steve G. Yoelin, M.D., one of the principal investigators for PEARL-1, said, “Today’s injectable aesthetics toolbox is limited to toxins and fillers which allow us to manipulate, but not rejuvenate, aging skin 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.”
Reported Increase Subject Satisfaction About Wrinkles Appearance
The study investigators and subjects reported meaningful and sustained improvements in skin aesthetic attributes, assessed using a Global Aesthetic Improvement Scale (“GAIS”), 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 for 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:
Subjects also reported improvements in wrinkles that increased from the first to second follow-up month, as assessed by GAIS:
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 for 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:
Subjects also reported improvements in wrinkles, as assessed by GAIS:
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.
From Jeune Aesthetics
Senior Vice President of Jeune said, “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. 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. Based on 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 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 conferences.
Conference Call, Webcast, and Presentation Information have been hosted on August 28, 2024. For those unable to listen to the live webcast, a replay is 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 Study
PEARL-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 concerning 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 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.
Please read Forward-Looking Statements
Prohost Observations
We are also excited to see profound aesthetic benefits following KB301 administration in both the lateral canthal region and the décolleté. We are also pleased to hear about reported high rates of improvement across several various key skin qualities the restoration of COL3 levels to more youthful levels and the natural-looking results of KB301 rejuvenated skin, which consumers are looking for today. The strong results in Cohort 4 enable the progression of KB301 into Phase 2 development for the treatment of wrinkles of the décolleté, a priority aesthetic site for which no FDA-approved injectables exist. The firm will be meeting with the FDA to enable the initiation of the Phase 2 study.
Click here to read more about Jeune Aesthetics.
Click here to read more about Krystal Biotech.
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