27 October 2021
Results Confirm the Safety and Tolerability of Sentinox and Suggest It Could Be Effective in Reducing Time to Negativization in SARS-CoV-2 Infected Patients
Geneva, Switzerland, October 27, 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 positive interim results from its clinical trial of nasal spray Sentinox in SARS-CoV-2 infected patients, confirming its safety and tolerability. Relief also reported that data from the study suggest that Sentinox could be effective in reducing the SARS-CoV-2 viral load at the level of the nasal mucosa.
The post-market, confirmatory, interventional, randomized, placebo controlled clinical study is expected to enroll a total of 57 patients. The study is designed to assess the efficacy and safety of Sentinox spray in reducing viral load in the upper respiratory airways of recently infected SARS-CoV-2 individuals and is being conducted by the Hygiene Unit of IRCCS Policlinico San Martino Hospital in Genoa, Italy and coordinated by Prof. Giancarlo Icardi as lead investigator.
The interim analysis, based on 30 patients who have completed the study -- 10 patients for each treatment group (0.5 ml into each nostril, 3x/day, 5x/day or control group, for five days) -- showed that all patients treated with Sentinox tested negative for SARS-CoV-2 by the end of the study period (Day 21). By contrast, one out of 10 patients in the control group was still positive by Day 21. All subjects using Sentinox 3 times a day had already tested negative by visit number 7 (V7; Day 10) vs. 70% of subjects in the control group over the same study period. At visit 4, 5 and 6, a trend in favor of the 3 times a day treated group vs. control group was observed (10% of patients using Sentinox tested negative at V4 vs 0% of patients in the control arm; 40% of patients using Sentinox tested negative vs 20% in the control arm at V5; 70% of patients using Sentinox tested negative vs 40% at V6). For the purpose of this study, subjects are considered negative when their COVID-19 test becomes negative and remains negative throughout the study period.
Prof. Giancarlo Icardi, head of the Hygiene Unit of IRCCS Policlinico San Martino Hospital in Genoa and lead investigator, commented, “The interim analysis results are encouraging. Indeed, the preliminary efficacy data suggest that using Sentinox, in addition to standard of care, could accelerate the time to a negative SARS-CoV-2 test result, thereby allowing patients to resume their normal daily activities sooner. By lowering the viral load in the nasal mucosa, the use of Sentinox could help reduce the transmissibility of the virus and, consequentially, its spread. Moreover, it is possible that, by including a larger number of patients and clinical parameters, Sentinox will prove to be a helpful tool for improving clinical outcomes in patients with mild COVID-19 in addition to standard of care. In general, we expect that the positive data obtained so far will be confirmed by the end of the study.”
Raghuram (Ram) Selvaraju, Chairman of the Board of Relief added, “These positive preliminary results serve to further illustrate the versatility of APR’s proprietary, globally patented Tehclo® nanotechnology platform. We are very encouraged by the data and remain committed to proactively progressing this program with the hope that we can eventually bring Sentinox to market as an important, additional, protective option for the treatment and spread of COVID-19.”
Sentinox is an acid-oxidizing solution (AOS) containing hypochlorous acid at 0.005%, certified in Europe on February 16, 2021 as Class III Medical Device (Certificate Nr. EPT 0477.MDD.21/4200.1). The device is intended for irrigation, cleansing and moistening of the nasal cavities and is indicated for (i) reducing the risk of infections caused by bacteria and viruses, including SARS-CoV-2, by lowering the nasal microbial load, (ii) symptomatic nasal care and (iii) nasal care in case of minor lesions/alterations of the nasal mucosa.
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. Follow us on LinkedIn.
RELIEF THERAPEUTICS Holding SA
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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 final results from the study will be as positive as the interim data, and (ii) those risks discussed in RELIEF THERAPEUTICS Holding SA's filings with the SIX, 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.