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Relief Therapeutics Holding SA / Key word(s): Study results Relief Therapeutics Announces Positive Final Results of RLF-TD011 Clinical Trial in Epidermolysis Bullosa GENEVA (NOV. 11, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced positive final results from its proof-of-concept, investigator-initiated clinical trial evaluating RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic condition characterized by fragile skin and chronic wounds. The clinical trial evaluated the effects of RLF-TD011 on microbiome diversity in chronic and acute wounds in EB patients, focusing primarily on the most severe forms of the disease (junctional and dystrophic EB). Effective wound healing is crucial for these patients, as their wounds are vulnerable to colonization or infection by pathogenic microorganisms, which can significantly reduce healing rates, increase the risk of sepsis, and lead to other severe complications. In particular, Staphylococcus aureus frequently colonizes EB wounds, where it contributes to chronic inflammation and disrupts the skin microbiome. The trial successfully met its primary endpoint. After eight weeks of treatment, RLF-TD011 led to a 24% decrease in S. aureus relative abundance (p=0.01), which correlated strongly (rho=0.64) with wound size reduction. Overall, 78% of treated wounds closed during the treatment period. Microbiome analysis further showed that RLF-TD011 treatment led to a marked increase in alpha diversity, with an increase in beneficial bacteria within the wound microbiome, effectively reducing S. aureus without disrupting beneficial bacteria. Improvements in microbiome diversity persisted through a four-week post-treatment observation period, evidencing RLF-TD011’s durability effect on the wound environment without signs of regression or exacerbation. “Epidermolysis bullosa is a devastating blistering skin disease that greatly impairs quality of life, particularly from the pain, itch, and risk of infection associated with open wounds. Evidence of reduction in the load of S. aureus and associated improved wound closure highlights the value of use of an antimicrobial spray during wound care,” said Prof. Amy Paller, Principal Investigator of the study and Chair of Dermatology at Northwestern University in Chicago, U.S. “These findings support the potential of RLF-TD011 to meaningfully advance wound care for patients with epidermolysis bullosa,” commented Giorgio Reiner, chief scientific officer of Relief. “The data demonstrates RLF-TD011’s antimicrobial efficacy, which is critical for infection management in chronic EB wounds, as well as its role in promoting wound healing. This is an important milestone in the development of RLF-TD011 toward regulatory approval. With this data in hand, we plan to consult with the U.S. Food and Drug Administration to finalize our development and regulatory plan.” Additional information about this investigator-initiated trial is available at ClinicalTrials.gov (NCT05533866). ABOUT RLF-TD011 ABOUT EPIDERMOLYSIS BULLOSA ABOUT RELIEF CONTACT: DISCLAIMER Additional features: File: Ad hoc End of Inside Information |
Language: | English |
Company: | Relief Therapeutics Holding SA |
Avenue de Secheron 15 | |
1202 Geneva | |
Switzerland | |
Phone: | +41 22 545 11 16 |
E-mail: | contact@relieftherapeutics.com |
Internet: | https://relieftherapeutics.com |
ISIN: | CH1251125998 |
Valor: | 125112599 |
Listed: | SIX Swiss Exchange |
EQS News ID: | 2026311 |
End of Announcement | EQS News Service |