Geneva, Switzerland, September 30, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), reported data published in the peer reviewed Journal of Wound Care, indicating that the company’s Nexodyn® acid-oxidizing solution (AOS), developed with APR’s proprietary Tehclo® technology, was found to be a highly effective treatment to support wound healing in infected or non-infected hard-to-heal leg ulcers. The data also confirmed the safety and tolerability of Nexodyn®.
Conducted by Robert Strohal, M.D., Professor and Department Head, Department of Dermatology, Federal Academic Teaching Hospital of Feldkirch, Austria, and colleagues, the open-label, randomized controlled MACAN study was conducted at two centers is Austria. A total of 50 patients were enrolled, with either infected or non-infected hard-to-heal leg ulcers of different etiology. Patients were treated for six weeks either with Nexodyn® AOS or standard of care (SOC) wound dressings.
In the patient group treated with Nexodyn® AOS, wounds exhibited a faster and more pronounced wound size reduction compared with wounds in the SOC group. Additionally, compared to SOC, the treatment group showed a markedly greater percentage of complete healing of hard-to-heal ulcers by the end of the study period (32% versus 8%, respectively). Furthermore, Nexodyn® demonstrated its ability to significantly reduce the wound pH (p<0.0001) and thus promote a faster healing process. In all patients with infected leg ulcers, local infection was overcome more rapidly with Nexodyn® AOS treatment. Overall, the efficacy of Nexodyn® AOS was found to be not only non-inferior but superior to SOC wound dressings.
“The publication of the MACAN study reconfirms the effectiveness of Nexodyn® AOS, developed with our proprietary, globally patented Tehclo® nanotechnology platform, versus SOC, providing further evidence of its unique ability to significantly reduce healing time, protect from risk of infection and reduce clinical signs of local infection,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “Importantly, the study showed that Nexodyn® AOS, with its antimicrobial properties, is able to control infection as a stand-alone treatment and that the reduction of the pH in the wound bed is directly associated with wound healing. Additionally, by restoring the prerequisites of the physiological healing process, use of Nexodyn® AOS can meaningfully help to reinitiate chronic wound closure. The published results show that Nexodyn® AOS is not only non-inferior, but is, in fact, superior to wound dressing standard of care, clearly establishing Nexodyn® AOS, as an important treatment for chronic hard-to-treat wounds.”
Raghuram (Ram) Selvaraju, Chairman of the Board of Relief added, “The marked improvement in wound healing reported in the MACAN study also bodes well for APR-TD011, developed with the same Tehclo® platform as Nexodyn® AOS, which is designed as a complete treatment for epidermolysis bullosa (EB) patients to prevent or reduce skin lesion infections and inflammation through modulation of the wound microenvironment to support a faster physiological wound healing. APR TD-011 was granted Orphan Drug Designation and may become an important treatment option for the estimated 250,000 EB patients worldwide.”
About Nexodyn® Acid-Oxidizing Solution (AOS)
Nexodyn® Acid-Oxidizing Solution (AOS) is a Tehclo®-based product proven to restart wound healing in stalled wounds by creating the ideal microenvironment to sustain the physiological healing process. A wealth of evidence and real-world experience consistently show accelerated closure with reduced infection rates and less wound-associated pain.
Nexodyn® AOS is a solution with three main features: highly pure and stabilized hypochlorous acid (HClO >95% of free chlorine species), acidic pH (2.5 – 3.0) and high Reduction-Oxidation Potential (ORP 1.000 – 1.200 mV). The product is a sprayable solution with ancillary antimicrobial properties intended for use in the debridement, irrigation, cleansing and moistening of acute and chronic wounds (e.g., diabetic foot ulcers, pressure ulcers, and vascular ulcers), post-surgical wounds, burns and other lesions. The product is certified in the European Union as a Class III medical device.
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.
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 symbol RLFTF. For more information, visit www.relieftherapeutics.com.
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