Chaperon Demonstrates Efficacy in Phase 2 Clinical Trial for COVID-19 Treatment... Inflammation Markers Reduced by Over 40%

[Asia Economy Reporter Hyunseok Yoo] Shaperon, a biopharmaceutical company specializing in new drug development, announced on the 19th the results of the Phase 2 clinical trial of its COVID-19 treatment ‘NuSepin®’ in Europe.

Along with the announcement of the Phase 2 clinical trial results, Shaperon stated, “NuSepin improved viral pneumonia symptoms in COVID-19 patients, shortened the treatment period, and simultaneously demonstrated safety.”

Seungyong Sung, Co-CEO of Shaperon, presented the Phase 2 clinical trial results of NuSepin at the ‘ARDS Drug Development Summit’ held via non-face-to-face video conference from the 13th to the 15th. Due to COVID-19, non-face-to-face academic forums have become more active, and many global pharmaceutical companies developing treatments for acute respiratory distress syndrome (ARDS) in COVID-19 patients participated in this summit.

With the continuous emergence of variant viruses, the speed of vaccination has not kept pace with the spread of the virus, causing a rapid increase in confirmed cases. Even countries where vaccines have been distributed enough to form herd immunity are seeing an increasing trend of infections caused by variant viruses. As a result, the development of antiviral drugs along with anti-inflammatory treatments is gaining worldwide attention.

For over 10 years, Shaperon has been developing sepsis treatments centered on NuSepin, which targets the inflammasome complex. Noting that inflammasomes are excessively activated in the lungs of COVID-19 pneumonia patients, a Phase 2 clinical trial was conducted since last year at five hospitals in Romania. This was a double-blind comparative study between a NuSepin injection group and a placebo group involving 64 COVID-19 pneumonia patients.

According to Shaperon, the Phase 2 clinical trial results showed that NuSepin exhibited dose-dependent symptom improvement effects. On the 9th day after administration, the recovery rate of the high-dose NuSepin group increased by 40% compared to the placebo group, and the average treatment period was shortened by more than 5 days compared to the placebo group.

Along with the improvement in COVID-19 pneumonia symptoms, significant reductions were confirmed in biomarkers indicating inflammation levels in the body, such as blood CRP, and inflammatory cytokines including IL-8, IL-6, and TNF-a. Additionally, no serious adverse drug reactions were observed during the trial, alleviating concerns about safety.

NuSepin is a novel anti-inflammatory therapeutic drug that inhibits the NLRP3 inflammasome in inflamed tissues, showing strong anti-inflammatory effects comparable to steroid drugs. Unlike the increase in mucormycosis caused by excessive steroid use, NuSepin is characterized by significantly fewer opportunistic infections and other side effects.

Unlike systemic steroidal anti-inflammatory drugs, NuSepin is a new drug synthesized in large quantities from an endogenous substance produced in the human liver, resulting in markedly fewer side effects, as already demonstrated in Phase 1 clinical trials. Furthermore, NuSepin acts only at the site of inflammation, offering superior safety compared to steroids, which cause side effects in systemic organs.

It is expected that upon successful completion of Phase 3 clinical trials, NuSepin could replace steroids, which have been widely used for many indications in the market. For example, in Alzheimer’s dementia patients, beta-amyloid accumulates in the brain causing encephalitis, which leads to brain nerve cell atrophy and memory loss. Shaperon confirmed symptom improvement by administering NuSepin’s raw material to animals with Alzheimer’s disease.

In March, Shaperon signed a technology transfer agreement with Gukjeon Pharm, which is synthesizing and mass-producing the raw pharmaceutical ingredients of NuSepin, ensuring stable supply of raw materials necessary for NuSepin’s global distribution in the future.

A Shaperon official said, “With the Phase 2 clinical trial results proving NuSepin’s efficacy and safety as a COVID-19 treatment, we expect to accelerate comprehensive and diverse development progress, including entry into Phase 3 clinical trials.”

He added, “Safety has already been secured through Phase 1 and 2 clinical trials. Since meaningful therapeutic effects against COVID-19 were confirmed in Phase 2, we want to obtain conditional sales approval not only in Korea but also in several overseas countries to help many critically ill COVID-19 patients return to daily life faster.”