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Relief Therapeutics gets IRB approval to initiate clinical trial of Nexodyn for Epidermolysis Bullosa

Geneva, Switzerland
Friday, September 23, 2022, 14:00 Hrs  [IST]

Relief Therapeutics Holding SA, a biopharmaceutical company, announced that an Investigator Initiated Trial with Nexodyn for Epidermolysis Bullosa (EB) has received IRB approval and will shortly enroll participants at Ann & Robert H. Lurie Children's Hospital of Chicago with Professor Amy Paller, M.D., Chair, Department of Dermatology, Feinberg School of Medicine, Northwestern University, serving as Principal Investigator. This trial represents an important step in the clinical development pathway of Relief’s APR-TD011, a pharmaceutical grade hypochlorous acid topical spray being evaluated for decolonization, symptom alleviation, and healing of EB wounds.

Professor Amy Paller stated “EB is a rare, inherited skin disease characterized by widely distributed, chronic wounds that easily become infected with a risk of sepsis and death. As there is no cure for EB, a crucial element of patient management involves proper and timely wound care. This pilot clinical study will evaluate how the bactericidal activity of this differentiated hypochlorous acid wound spray that has been shown to kill methicillin-sensitive and methicillin-resistant Staphylococcus aureus, as well as Pseudomonas aeruginosa, could reduce wound colonization, thus improving the microbiome. Future studies will determine the impact of APR-TD011 on infection control, avoidance of chronic antibiotic use, accelerated wound healing, and quality of life for patients living with EB.”

Dr. Nermeen Varawalla, chief medical officer of Relief Therapeutics, noted, “This proof-of-concept clinical trial, to be conducted in 15 participants over a 12-week study period, will be most valuable for the swift, effective and efficient execution of Relief’s clinical development plan for APR-TD011. The clinical data from this Investigator Initiated Trial will facilitate the design and conduct of follow-on, multi-centre, pivotal clinical trials for future, potential US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval of APR-TD011 as an effective, convenient, well tolerated, anti-microbial wound management solution for EB.”

Nexodyn, engineered by the TEHCLO proprietary technology, is a highly pure and stabilized hypochlorous acid (HClO >95% of free chlorine species), with pH between 2.5 - 3.0 and high Reduction-Oxidation Potential (ORP 1.000 - 1.200 mV). It is presented as a self-administered sprayable solution intended for use in the debridement, irrigation, cleansing, and moistening of acute and chronic wounds and is certified in the EU as a Class III medical device and, in the US, as a 510(k) cleared unclassified device. The spray formulation enables wound application whilst avoiding skin contact and cross-contamination, of a solution that has been consistently shown to accelerate wound closure with reduced infection rates.

APR-TD011, manufactured with the company’s proprietary TECHLO technology, is a GMP grade pharmaceutical hypochlorous acid wound solution that has been granted an FDA Orphan Drug Designation for EB. If approved, it would be the first product specifically indicated to prevent or reduce colonization and infections in EB wounds, and via modulation of the wound microbiome accelerate wound healing and closure, while reducing antibiotic use. This, along with its anti-inflammatory action, could provide symptom relief and wound healing.

EB is a group of rare, genetic, life-threatening connective tissue disorders characterized by fragile skin and mucous membrane with severe blistering throughout the body. There are currently an estimated 250,000 patients with EB worldwide, with an estimated 30,000 patients in the European Union and 20,000 patients in the US.
 
Relief is a Swiss, commercial-stage, biopharmaceutical company focused on identification, development and commercialization of novel, patent protected products intended for the treatment of rare and ultra-rare diseases including metabolic disorders, pulmonary diseases, and connective tissue disorders.

 

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