Shaperon Completes Investigator Meeting in the U.S. for Atopic Dermatitis Treatment 'HY209gel'
*SEOUL, SOUTH KOREA / ACCESSWIRE / December 18, 2023 / *Shaperon Inc. (378800.KQ), a KOSDAQ-listed, Korean biotech company developing innovative immune drugs, has announced the successful completion of an investigator meeting for the Phase 2 clinical trial for the atopic dermatitis treatment ‘HY209gel' in Dallas, Texas, USA on December 9, 2023. The investigator meeting was organized to introduce and discuss the operational progress and future plans of the clinical trial, inviting the principal investigator and site staff from global institutions.
Dr. Sadick, founder of Sadick Dermatology in NYC and the study's principal investigator, who has more than 25 years of experience in large multicenter studies, said at this meeting, "There are still many patients around the world and in North America with atopic dermatitis that have unmet therapeutic needs. We're happy to be part of Shaperon's HAPPY (short title of HY209-AD-02, IND No.160935) trial, which introduces a new topical treatment of atopic dermatitis that will offer better results, a high safety profile, and allow patients to improve their symptoms and clinical outcomes for treatment of atopic dermatitis. We're very proud to partner with Shaperon in this clinical trial which will improve the results of treatment for atopic dermatitis."
Professor Jungim Na from Seoul National University, Bundang Hospital, which planned to participate as a clinical institution in Korea, said with expectation, "Patients with scalp lesions that do not respond to other treatments can also be included in this study. I am even more excited about the results for scalp lesions."
In September 2023, Shaperon received IND approval from the U.S. FDA to conduct a global Phase 2 trial of ‘HY209.' This clinical trial aims to confirm the effectiveness of ‘HY209gel' in improving the Eczema Area and Severity Index (EASI score) compared to a placebo group in patients with atopic dermatitis. The multinational Phase 2 trial will assess safety, efficacy, pharmacokinetics, and tolerability in 210 patients with mild to moderate atopic dermatitis who are of various racial backgrounds. Participants will apply either the placebo or ‘HY209gel' using a double-blind method for approximately 8 weeks.
Shaperon has already filed a patent for discovering biomarkers that selectively identify specific patient groups showing excellent effects with ‘HY209gel,' enabling personalized treatment. The upcoming multinational clinical trial will examine whether ‘HY209gel' exhibits outstanding effectiveness on diverse skin types and evaluate the increased therapeutic effects with dose escalation. Additionally, Shaperon aims to enhance investigational product (IP) management efficiently by utilizing a smartwatch-based AI drug management system by InHandPlus Inc, which is expected to increase the reliability of the data.
‘HY209gel' is the world's first class of inflammasome inhibitors for the treatment of atopic dermatitis as a GPCR19 agonist. It is expected to show promising outcomes by inhibiting both the priming and activating phase of inflammasome results and increasing the number of inflammation-suppressing cells in the skin. It received attention at the BIO Investor Forum in San Francisco last October and the BIO-Europe event held in Munich, Germany in November by announcing that more than 70% of patients were positive for specific biomarkers as a result of the Korean phase 2 clinical trial, and that the data presented is expected to enhance safety significantly and more effectively than the JAK inhibitors or PDE4 inhibitors on the market.
Dr. Shawn Seong, the visionary founder and CEO of Shaperon, stated "‘HY209gel' is characterized by its similar effect to steroids with less side effects and is expected to enhance safety," and explained the future strategy, saying, "By proving the superiority of ‘HY209gel' through Phase 2 in the United States, we expect to strengthen the foundation for entering the global market."
*About Shaperon*
Shaperon is a clinical stage biotech company developing novel inflammasome inhibitors (small molecule). With unique and novel modality, which is best suited to address complex immune-mediated inflammatory disorders, Shaperon is currently developing multiple clinical programs in atopic dermatitis, cytokine release syndrome, Alzheimer's disease, ulcerative colitis, NASH, etc. Contact Shaperon at +82-2-6083-8315 or visit us online at www.shaperon.com.
*SOURCE: *Shaperon
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