Novel Nasal Spray Effective with SARS-CoV-2 Infected Patients

Switzerland-based RELIEF THERAPEUTICS Holding SA today announced that its wholly-owned subsidiary, APR Applied Pharma Research SA reported positive interim results from its clinical trial of nasal spray Sentinox in SARS-CoV-2 virus-infected patients.

Relief also reported that data from the study suggest that Sentinox's safety and tolerability 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 57 patients.

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 three 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 visits 4, 5, and 6, a trend in favor of the three 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 this study, subjects were considered negative when their COVID-19 test became negative and remained 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 in a press release, "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."

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. The device is intended for irrigation, cleansing, and moistening nasal cavities.

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. to treat respiratory deficiency due to COVID-19.