Relief Therapeutics Announces IRB Approval and Initiation of an Investigator Initiated Trial of Nexodyn for Epidermolysis Bullosa at Ann & Robert H. Lurie Children's Hospital of Chicago

Rhea-AI Summary

Relief Therapeutics has announced the initiation of an Investigator Initiated Trial for Nexodyn to address Epidermolysis Bullosa (EB), a rare skin condition affecting about 250,000 patients globally. The trial, approved by the IRB, will be led by Professor Amy Paller at a Chicago hospital, enrolling 15 participants over 12 weeks. This trial aims to evaluate the effectiveness of APR-TD011, a hypochlorous acid topical spray, in managing EB wounds. Positive outcomes could lead to FDA and EMA approvals, enhancing treatment options for EB patients.

Positive

• The trial has received IRB approval, facilitating clinical development.
• APR-TD011 has FDA Orphan Drug Designation, indicating potential market exclusivity.
• Successful outcomes may lead to pivotal trials for regulatory approvals.
• The focus on a significant unmet medical need aligns with the company's strategic goals.

Negative

• The trial's success is uncertain, with risks of failure in proving efficacy.
• The study involves only a small participant group (15), which may limit data reliability.
• Any potential delays in approvals could impact the company's financial outlook.

Professor Amy Paller, M.D., will serve as Principal Investigator to evaluate Nexodyn for the management of colonized dystrophic and junctional Epidermolysis Bullosa wounds, an important unmet need in this group of rare inherited skin diseases that affects approximately 250,000 patients worldwide.

GENEVA, SWITZERLAND / ACCESSWIRE / September 22, 2022 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) (" Relief "), a biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis, announced today 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-center, pivotal clinical trials for future, potential U.S. 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."

ABOUT Nexodyn and APR-TD011

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 U.S.

ABOUT RELIEF THERAPEUTICS

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. Relief's diversified pipeline consists of assets that have the potential to effectively address significant unmet medical needs, including PKU GOLIKE ^® , engineered with the proprietary Physiomimic technology, which is the first prolonged-release amino acid product commercialized for the dietary management of phenylketonuria ("PKU"). Relief has a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including Urea Cycle Disorders ("UCDs") and Maple Syrup Urine Disease ("MSUD"). Relief also continues to develop aviptadil for several rare pulmonary indications. Further, Relief is undertaking the clinical development of APR-TD011, a differentiated acid oxidizing solution of hypochlorous acid intended for the treatment of epidermolysis bullosa ("EB"), a group of rare, genetic, life-threatening connective tissue disorders; APR-TD011 has been granted Orphan Drug Designation by the FDA. Finally, Relief is commercializing several legacy products via licensing and distribution partners.

RELIEF THERAPEUTICS Holding SA 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 . Follow Relief on LinkedIn .

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jack Weinstein
Chief Financial Officer and Treasurer
contact@relieftherapeutics.com

FOR MEDIA/INVESTOR INQUIRIES:
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether the study described above will be successful (ii) whether Nexodyn and APR-TD011 will ever be approved for the treatment of EB or any other disease, and (iii) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX and with the U.S. Securities and Exchange Commission, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

SOURCE: Relief Therapeutics Holdings AG

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FAQ

What is the significance of the IRB approval for Relief Therapeutics?

The IRB approval allows Relief Therapeutics to proceed with its Investigator Initiated Trial for Nexodyn, a crucial step in clinical development for managing Epidermolysis Bullosa.

Who is leading the Investigator Initiated Trial for Epidermolysis Bullosa?

Professor Amy Paller, M.D., will serve as the Principal Investigator for the trial at Ann & Robert H. Lurie Children's Hospital of Chicago.

What is the expected duration of the Nexodyn trial?

The trial will last for 12 weeks and will enroll 15 participants.

What potential benefits does APR-TD011 offer for Epidermolysis Bullosa patients?

APR-TD011 could potentially manage wound healing, reduce infection rates, and lessen the need for chronic antibiotic use.

What is the market potential for APR-TD011 in treating Epidermolysis Bullosa?

If approved, APR-TD011 would be the first product specifically indicated for preventing infections in EB wounds, addressing a significant unmet medical need for approximately 250,000 patients worldwide.