4/2/2023 0 Comments Jmol trial![]() ![]() The Company estimates the global market opportunity for EB to exceed $1.0 billion.ĪBOUT RLF-TD011 (formerly known as APR-TD011) is 19.57 per 1 million live births and the prevalence is 11.07 per 1 million population. The National Epidermolysis Bullosa Registry (NEBR) reports, based on 16 years of data, that the incidence of EB in the U.S. Currently there is no cure or approved treatments for EB in the U.S. Patients with JEB and DEB are at increased risk for serious complications, including aggressive squamous cell carcinoma. There are four main types of EB, which are classified based on the depth, or level, of blister formation: EB simplex (EBS), junctional EB (JEB), dystrophic EB (DEB) and Kindler syndrome. In severe cases, the blisters may develop into chronic wounds or occur inside the body, such as the lining of the mouth or stomach. “These data will facilitate the design and conduct of follow-on, multi-center, pivotal registration clinical trials to determine the impact of RLF-TD011 on infection control, avoidance of chronic antibiotic use, accelerated wound healing and quality of life for patients living with EB.”Īdditional information about this investigator-initiated study is available at ( NCT05533866).Įpidermolysis bullosa (EB), also known as “Butterfly Skin,” is a group of rare, genetic, life-threatening connective tissue disorders characterized by skin fragility and blistering, which may appear in response to minor injury, even from heat, rubbing or scratching. ![]() ![]() “The results of this study will be most valuable for the swift, effective and efficient execution of our clinical development plan for RLF-TD011,” said Nermeen Varawalla, M.D., Ph.D., chief medical officer, Relief Therapeutics. aeruginosa culture-positive wounds at Ann & Robert H. ![]() The study is currently enrolling up to 17 patients diagnosed with junctional epidermolysis bullosa (JEB) or dystrophic epidermolysis bullosa (DEB) with S. “We are eager to assess the effect of RLF-TD011 on the microbiome in colonized dystrophic and junctional epidermolysis bullosa wounds and determine tolerability, symptom improvement, reduction of lesion size and wound closure.” As there is no cure for EB, a crucial element of patient management involves rigorous and timely wound care,” said professor Amy Paller, M.D., chair, department of dermatology, Feinberg School of Medicine, Northwestern University and principal investigator of the study. “EB is a rare, inherited skin disease characterized by widely distributed, painful, chronic wounds that easily become infected, resulting in an elevated risk of sepsis and death. All study participants will have the option to continue treatment in a six-month open-label study extension. aeruginosa will be treated with RLF-TD011 for eight weeks followed by discontinuation of treatment for four weeks with assessment of their wound microbiome at each stage. Patients with dystrophic or junctional EB whose wounds are colonized by S. The primary aim of this study will be to assess changes in the skin microbiome ( Staphylococcus aureus, Pseudomonas aeruginosa, commensal organisms) before, during and after treatment with RLF-TD011, a self-administered, sprayable solution enabling targeted application while avoiding skin contact and cross-contamination. 14, 2023 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) ("Relief Therapeutics" or the "Company"), a biopharmaceutical company developing and commercializing novel, patent-protected products in select specialty and rare diseases, announced today the first three patients have been enrolled in a proof-of-concept, investigator-initiated study to evaluate RLF-TD011 as a treatment for epidermolysis bullosa (EB). Relief Therapeutics Announces Enrollment of First Three Patients in Proof-of-Concept Clinical Trial of RLF-TD011 for the Treatment of Epidermolysis Bullosa ![]()
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