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Relief Therapeutics Announces Promising Preliminary Results of RLF-TD011 Clinical Trial in Epidermolysis Bullosa

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Relief Therapeutics has announced promising preliminary results from its proof-of-concept clinical trial evaluating RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic condition. The study focused on the effects of RLF-TD011 on microbiome diversity in EB wounds.

Key findings include:

  • Statistically significant reduction in Staphylococcus aureus
  • Increase in beneficial bacteria in EB wounds
  • Marked improvement in alpha microbiome diversity
  • Notable correlation between wound healing and Staphylococcus aureus reduction

Prof. Amy Paller, Principal Investigator and Chair of Dermatology at Northwestern University, highlighted the importance of addressing Staphylococcus aureus overgrowth in EB patients. The preliminary results suggest RLF-TD011's potential to target a critical need in EB treatment, potentially improving patient outcomes.

Relief Therapeutics ha annunciato risultati preliminari promettenti dal suo studio clinico di proof-of-concept che valuta RLF-TD011 per il trattamento dell'epidermolisi bollosa (EB), una condizione genetica rara. Lo studio si è concentrato sugli effetti di RLF-TD011 sulla diversità del microbioma nelle ferite da EB.

I risultati chiave includono:

  • Riduzione statisticamente significativa di Staphylococcus aureus
  • Aumento dei batteri benefici nelle ferite da EB
  • Marka miglioramento della diversità alpha del microbioma
  • Correlazione notevole tra la guarigione delle ferite e la riduzione di Staphylococcus aureus

La Prof.ssa Amy Paller, Investigatrice Principale e Presidente di Dermatologia presso la Northwestern University, ha sottolineato l'importanza di affrontare la proliferazione di Staphylococcus aureus nei pazienti con EB. I risultati preliminari suggeriscono il potenziale di RLF-TD011 di rispondere a un bisogno critico nel trattamento dell'EB, con la possibilità di migliorare i risultati per i pazienti.

Relief Therapeutics ha anunciado resultados preliminares prometedores de su ensayo clínico de prueba de concepto que evalúa RLF-TD011 para el tratamiento de la epidermólisis bullosa (EB), una condición genética rara. El estudio se centró en los efectos de RLF-TD011 en la diversidad del microbioma en las heridas de EB.

Los hallazgos clave incluyen:

  • Reducción estadísticamente significativa de Staphylococcus aureus
  • Aumento de bacterias beneficiosas en las heridas de EB
  • Mejora notable en la diversidad alfa del microbioma
  • Correlación notable entre la curación de heridas y la reducción de Staphylococcus aureus

La Prof. Amy Paller, Investigadora Principal y Presidenta de Dermatología en la Universidad Northwestern, destacó la importancia de abordar el crecimiento desmedido de Staphylococcus aureus en pacientes con EB. Los resultados preliminares sugieren el potencial de RLF-TD011 para atender una necesidad crítica en el tratamiento de la EB, lo que podría mejorar los resultados en los pacientes.

릴리프 테라퓨틱스는 유망한 초기 결과를 발표했습니다. 이 결과는 RLF-TD011표피 수포증 (EB) 치료를 평가하는 개념 증명 임상 시험에서 도출된 것입니다. 이 연구는 EB 상처에서 RLF-TD011이 미생물군 다양성에 미치는 영향을 중점적으로 다뤘습니다.

주요 발견 사항은 다음과 같습니다:

  • 환돈균 (Staphylococcus aureus)의 통계적으로 유의미한 감소
  • EB 상처에서 유익균의 증가
  • 알파 미생물군 다양성의 현저한 개선
  • 상처 치유와 환돈균 감소 사이의 주목할 만한 상관관계

노스웨스턴 대학교 피부과 의장인 에이미 팔러 교수는 EB 환자에서 환돈균 과잉 성장을 치료하는 것의 중요성을 강조했습니다. 초기 결과는 RLF-TD011이 EB 치료의 중요 요구에 대응할 잠재력이 있음을 시사하며, 환자 결과를 개선할 가능성을 제시합니다.

Relief Therapeutics a annoncé des résultats préliminaires prometteurs de son essai clinique de preuve de concept évaluant RLF-TD011 pour le traitement de l'épidermolyse bulleuse (EB), une maladie génétique rare. L'étude s'est concentrée sur les effets de RLF-TD011 sur la diversité du microbiome dans les plaies d'EB.

Les résultats clés incluent :

  • Réduction statistiquement significative de Staphylococcus aureus
  • Augmentation des bactéries bénéfiques dans les plaies d'EB
  • Amélioration marquée de la diversité alpha du microbiome
  • Corrélation notable entre la guérison des plaies et la réduction de Staphylococcus aureus

La Professeure Amy Paller, chercheuse principale et présidente de dermatologie à l'Université Northwestern, a souligné l'importance de traiter la prolifération de Staphylococcus aureus chez les patients atteints d'EB. Les résultats préliminaires suggèrent le potentiel de RLF-TD011 à répondre à un besoin critique dans le traitement de l'EB, ce qui pourrait potentiellement améliorer les résultats pour les patients.

Relief Therapeutics hat vielversprechende vorläufige Ergebnisse aus seiner Proof-of-Concept-Studie zur Evaluierung von RLF-TD011 zur Behandlung von Epidermolysis bullosa (EB), einer seltenen genetischen Erkrankung, bekannt gegeben. Die Studie konzentrierte sich auf die Auswirkungen von RLF-TD011 auf die Mikrobiomvielfalt in EB-Wunden.

Wesentliche Ergebnisse umfassen:

  • Statistisch signifikante Reduktion von Staphylococcus aureus
  • Steigerung der nützlichen Bakterien in EB-Wunden
  • Deutliche Verbesserung der alpha-Mikrobiomvielfalt
  • Bemerkenswerte Korrelation zwischen Wundheilung und Reduktion von Staphylococcus aureus

Prof. Amy Paller, Hauptprüferin und Vorsitzende der Dermatologie an der Northwestern University, hob die Bedeutung hervor, das Überwachsen von Staphylococcus aureus bei EB-Patienten anzugehen. Die vorläufigen Ergebnisse deuten auf das Potenzial von RLF-TD011 hin, einen kritischen Bedarf in der EB-Behandlung zu decken, was möglicherweise die Behandlungsergebnisse der Patienten verbessern könnte.

Positive
  • Statistically significant reduction in Staphylococcus aureus in EB wounds
  • Increase in beneficial bacteria and improvement in alpha microbiome diversity
  • Correlation observed between wound size reduction and Staphylococcus aureus reduction
  • Potential for RLF-TD011 to address a critical need in EB treatment
Negative
  • None.

GENEVA, SWITZERLAND / ACCESSWIRE / October 8, 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 promising preliminary 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 study was designed to evaluate the effects of RLF-TD011 on microbiome diversity in wounds of patients with dystrophic and junctional EB. Microbiome analysis showed a statistically significant reduction in Staphylococcus aureus and an increase in beneficial bacteria in EB wounds, accompanied by a marked improvement in alpha microbiome diversity. A notable correlation between wound healing, specifically wound size reduction, and Staphylococcus aureus reduction was also observed. Further analyses will be available in the coming weeks.

Culture-based studies have shown that up to 93% of wounds in EB patients are colonized by Staphylococcus species. "Overgrowth of Staphylococcus aureus can lead to infection in our patients with epidermolysis bullosa and inhibits wound healing," said Prof. Amy Paller, Principal Investigator of the study and Chair of Dermatology at Northwestern University. The presence of these pathogens contributes to chronic inflammation and alterations in the skin microbiome, both of which exacerbate poor wound healing. The preliminary results showing a reduction in Staphylococcus aureus without disrupting the beneficial bacteria are particularly promising, as they highlight the potential of RLF-TD011 to address a critical need for targeted treatments in EB, ultimately improving patient outcomes.

Additional information about this investigator-initiated study 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 clinical trials1. In preliminary cases, EB patients using RLF-TD011 showed improvements in blistering and tissue repair. The U.S. Food and Drug Administration (FDA) granted it orphan drug designation for EB, and Relief plans to seek 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. According to the National Epidermolysis Bullosa Registry, EB affects approximately 19.57 per million live births in the United States. Globally, EB affects about 500,000 people.

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.

References

1 Lacopi E., et al. The Use of a Novel Super-Oxidized Solution on Top of Standard Treatment in the Home Care Management of Postsurgical Lesions of the Diabetic Foot Reduces Reinfections and Shortens Healing Time. Int J Low Extrem Wounds. 2018 Dec; 17(4):268-274.

SOURCE: Relief Therapeutics Holding SA



View the original press release on accesswire.com

FAQ

What are the preliminary results of Relief Therapeutics' RLF-TD011 clinical trial for epidermolysis bullosa (RLFTY)?

The preliminary results show a statistically significant reduction in Staphylococcus aureus, an increase in beneficial bacteria, improved alpha microbiome diversity, and a correlation between wound healing and Staphylococcus aureus reduction in EB wounds.

How does RLF-TD011 potentially benefit patients with epidermolysis bullosa (RLFTY)?

RLF-TD011 shows potential to reduce Staphylococcus aureus in EB wounds without disrupting beneficial bacteria, which could lead to improved wound healing and better patient outcomes in epidermolysis bullosa treatment.

What is the significance of reducing Staphylococcus aureus in epidermolysis bullosa wounds (RLFTY)?

Reducing Staphylococcus aureus is significant because its overgrowth can lead to infection, inhibit wound healing, and contribute to chronic inflammation in EB patients. Targeting this pathogen could potentially improve wound healing outcomes.

Who is the Principal Investigator of the RLF-TD011 clinical trial for epidermolysis bullosa (RLFTY)?

The Principal Investigator of the study is Prof. Amy Paller, who is also the Chair of Dermatology at Northwestern University.

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