Relief Therapeutics Announces Positive Final Results of RLF-TD011 Clinical Trial in Epidermolysis Bullosa
Relief Therapeutics announced positive final results from its proof-of-concept clinical trial of RLF-TD011 for treating epidermolysis bullosa (EB), a rare genetic condition causing fragile skin and chronic wounds. The trial met its primary endpoint, showing a 24% decrease in S. aureus relative abundance (p=0.01) after eight weeks of treatment, correlating with wound size reduction. 78% of treated wounds closed during the treatment period. The treatment increased beneficial bacteria and microbiome diversity, with effects persisting through a four-week post-treatment period. The company plans to consult with the FDA to finalize development and regulatory plans.
Relief Therapeutics ha annunciato risultati finali positivi dal suo studio clinico di fase di prova di concetto per RLF-TD011 nel trattamento dell'epidermolisi bollosa (EB), una rara condizione genetica che causa pelle fragile e ferite croniche. Lo studio ha raggiunto il suo obiettivo primario, mostrando una diminuzione del 24% dell'abondanza relativa di S. aureus (p=0.01) dopo otto settimane di trattamento, correlata a una riduzione della dimensione delle ferite. Il 78% delle ferite trattate si è chiuso durante il periodo di trattamento. Il trattamento ha aumentato i batteri benefici e la diversità del microbioma, con effetti che persistono per un periodo post-trattamento di quattro settimane. L'azienda prevede di consultarsi con la FDA per finalizzare i piani di sviluppo e regolamentazione.
Relief Therapeutics anunció resultados finales positivos de su ensayo clínico de prueba de concepto para RLF-TD011 en el tratamiento de epidermólisis ampollosa (EB), una rara condición genética que causa piel frágil y heridas crónicas. El ensayo cumplió con su objetivo primario, mostrando una disminución del 24% en la abundancia relativa de S. aureus (p=0.01) después de ocho semanas de tratamiento, lo que se correlaciona con una reducción en el tamaño de las heridas. El 78% de las heridas tratadas cerraron durante el periodo de tratamiento. El tratamiento aumentó las bacterias beneficiosas y la diversidad del microbioma, con efectos que persistieron durante un período de cuatro semanas posterior al tratamiento. La empresa planea consultar con la FDA para finalizar los planes de desarrollo y regulación.
Relief Therapeutics는 RLF-TD011의 수포성 표피 박리증 (EB) 치료에 대한 개념 증명 임상 시험의 긍정적인 최종 결과를 발표했습니다. EB는 피부가 약하고 만성 상처를 유발하는 희귀 유전 질환입니다. 이 시험은 주요 목표를 달성하였으며, 8주 치료 후 S. aureus의 상대적 풍부성이 24% 감소했음을 보여주었고(p=0.01), 이는 상처 크기 감소와 관련이 있었습니다. 치료받은 상처의 78%가 치료 기간 중에 치유되었습니다. 치료는 유익한 박테리아와 미생물 군집의 다양성을 증가시켰으며, 치료 후 4주 동안 이러한 효과가 지속되었습니다. 회사는 FDA와 상담하여 개발 및 규제 계획을 최종화할 예정입니다.
Relief Therapeutics a annoncé des résultats finaux positifs de son essai clinique de preuve de concept pour RLF-TD011, destiné au traitement de l'épidermolyse bulleuse (EB), une condition génétique rare provoquant une peau fragile et des plaies chroniques. L'essai a atteint son objectif principal, montrant une diminution de 24% de l'abondance relative de S. aureus (p=0.01) après huit semaines de traitement, corrélée à une réduction de la taille des plaies. 78% des plaies traitées se sont fermées pendant la période de traitement. Le traitement a augmenté les bactéries bénéfiques et la diversité du microbiome, avec des effets persistants pendant une période de quatre semaines après le traitement. L'entreprise prévoit de consulter la FDA pour finaliser les plans de développement et de réglementation.
Relief Therapeutics kündigte positive Endergebnisse aus seiner proof-of-concept-Studie für RLF-TD011 zur Behandlung von epidermolysis bullosa (EB) an, einer seltenen genetischen Erkrankung, die zu empfindlicher Haut und chronischen Wunden führt. Die Studie erreichte ihr primäres Ziel und zeigte einen Rückgang der relativen Häufigkeit von S. aureus um 24% (p=0.01) nach achtwöchiger Behandlung, was mit einer Verringerung der Wundgröße korrelierte. 78% der behandelten Wunden schlossen sich während des Behandlungszeitraums. Die Behandlung erhöhte die nützlichen Bakterien und die Mikrobiomvielfalt, wobei die Effekte über einen Zeitraum von vier Wochen nach der Behandlung anhielten. Das Unternehmen plant, sich mit der FDA zu beraten, um Entwicklungs- und Regulierungspläne abzuschließen.
- Trial met primary endpoint with 24% decrease in S. aureus abundance
- 78% wound closure rate during treatment period
- Sustained improvement in microbiome diversity through 4-week post-treatment
- Strong correlation (rho=0.64) between S. aureus reduction and wound healing
- None.
GENEVA, SWITZERLAND / ACCESSWIRE / November 11, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB: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
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
RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief's proprietary TEHCLO™ technology. With strong antimicrobial properties, RLF-TD011 is a sprayable, self-administered solution for targeted wound application while avoiding skin contact and cross-contamination. RLF-TD011 has shown efficacy in accelerating wound closure and reducing infections in certain clinical trials on non-EB wounds. In preliminary cases, EB patients using RLF-TD011 showed improvements in blistering and tissue repair. RLF-TD011 aims to address an unmet need in EB care by efficiently controlling infection and inflammation while reducing antibiotic use and easing the intensive, time-consuming wound care routine required by current treatments. The U.S. Food and Drug Administration granted it orphan drug designation for EB, and Relief plans to seek qualified infectious disease product (QIDP) designation for extended market exclusivity.
ABOUT EPIDERMOLYSIS BULLOSA
Epidermolysis bullosa (EB) is a group of rare, inherited connective tissue disorders characterized by extreme skin fragility, leading to blistering and wounds from minor friction or injury. In severe cases, blisters can develop into chronic wounds or form in internal organs such as the mouth or esophagus, leading to painful wounds, recurrent infections, and a deeply impacted quality of life. EB is classified into several major inherited subtypes, each defined by the depth of blister formation within the skin's layers: epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB), junctional epidermolysis bullosa (JEB) and Kindler syndrome (KS). Treatment is intensive and includes wound care, infection prevention, and pain management. Approximately 500,000 individuals worldwide are affected by EB.
ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief's portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.
CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com
DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief's filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief's filings with the SEC are available on the SEC EDGAR database at www.sec.gov . Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.
SOURCE: Relief Therapeutics Holding SA
View the original press release on accesswire.com
FAQ
What were the main results of Relief Therapeutics' RLF-TD011 trial for epidermolysis bullosa?
How effective was RLFTY's RLF-TD011 in treating EB wounds?
What are the next steps for Relief Therapeutics' RLF-TD011 development?
