Chaperone Announces Final Results of Phase 2 Clinical Trial for COVID-19 Treatment

Amid the 4th pandemic of COVID-19 in full swing, Chaperon, a new drug development bio company, announced on the 19th that it has announced the results of the European phase 2 clinical trial of NuSepin®, a treatment for COVID-19. Along with the announcement of the results of the phase 2 clinical trial on the same day, Chaperon said, “Nucepin improved the symptoms of viral pneumonia in COVID-19 patients, shortened the treatment period, and proved safety.”

Seong-yong Seong, co-CEO of Chaperon, announced the results of the Phase 2 clinical trial of Nucepin at the ‘ARDS Drug Development Summit’ held by a non-face-to-face videoconference from July 13 to 15. As non-face-to-face academic forums have been activated due to COVID-19, a number of global pharmaceutical companies that are developing treatments for acute respiratory distress syndrome in patients with Corona participated in this summit.

Due to the continuous emergence of the mutant virus, the rate of vaccination cannot keep up with the rate of virus spread, and even in countries where the vaccine has been distributed enough to form a collective immunity as the number of confirmed cases rapidly increase, the number of cases of infection by the mutant virus is increasing. The development of therapeutics is attracting attention worldwide.

Chaperone has been developing sepsis treatment for the past 10 years with Nucepin, which targets the inflammatory complex. Was it a ‘prepared coincidence’? Based on the fact that the inflammatory complex is excessively activated in the lungs of patients with COVID-19 pneumonia, starting from 2020, a double-blind comparative trial between the nucepin injection group and the placebo group was conducted on 64 patients with COVID-19 pneumonia at 5 hospitals in Romania. The award test was conducted.

According to Chaperon, as a result of this phase 2 clinical trial, nucepine showed symptomatic improvement in proportion to the dose administered, and on the 9th day after administration, the recovery rate of the high-dose nucepine group increased by 40% compared to the placebo group, and the average treatment period was 5 days compared to the placebo group. It was confirmed that it was shortened abnormally.

In proportion to the improvement of the symptoms of COVID-19 pneumonia by Nusepin, significant reductions in blood CRP, a biomarker indicating the level of inflammation in the body, and inflammatory cytokines IL-8, IL-6 and TNF-a were also confirmed. In addition, no serious adverse drug reactions were observed during the trial, thus dispelling concerns about safety.

Nucepin is a new anti-inflammatory drug that shows a strong anti-inflammatory effect at the level of steroids based on a novel mechanism of action that inhibits the NLRP3 inflammatory complex in inflamed tissues. It is characterized by significantly fewer opportunistic infections and other side effects regardless of the increase in black fungal infections due to excessive use of steroids.

Unlike steroidal anti-inflammatory drugs that act systemically, Nucepine is a new drug mass-produced by synthesizing endogenous substances made in the human liver. In addition, since nucepin acts limited to the inflamed site, it has excellent safety in contrast to steroids that show side effects in organs throughout the body.

If phase 3 clinical trials are successfully completed in the future, it is expected that it will be able to replace steroids that have been widely used for many indications in the market. For example, in Alzheimer’s dementia patients, beta-amyloid accumulates in the brain and causes encephalitis, which causes atrophy of cranial nerve cells and loss of memory. Chaperone confirmed that the symptoms improved by administering the raw material of Nucepine to animals with Alzheimer’s disease.

Meanwhile, Chaperon signed a technology transfer contract with Kukjeon Pharmaceuticals in March, and Kukjeon Pharmaceuticals is synthesizing and mass-producing Nucepin’s raw materials, so it has stably secured raw materials necessary for global distribution of Nucepin in the future.

A Chaperon official said, “As the efficacy and safety of Nucepine as a treatment for COVID-19 has been proven through the results of this phase 2 clinical trial, we expect to accelerate the progress of comprehensive and diverse development such as entering the phase 3 clinical trial.” “Clinical 1 Safety has already been secured through the results of phase 2 and phase 2, and a meaningful treatment effect for COVID-19 has been secured in this phase 2 clinical trial. I want to help,” he said.

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