NewG Lab Pharma "Oral COVID-19 Treatment Phase 1 Clinical Trial Success... One-Fifth the Price of Pfizer"

[Asia Economy Reporter Hyunseok Yoo] NewGel Lab Pharma announced on the 3rd that its subsidiary, NewGel Therapeutics, has successfully completed Phase 1 clinical trials of the oral COVID-19 treatment drug "NewGen Nafamostat Tablets" conducted at Seoul National University Hospital. Given that the Ministry of Food and Drug Safety promised expedited approval reviews for COVID-19 treatments in this year's New Year's address, the company plans to achieve rapid product approval.

NewGel Therapeutics and Professor Seunghwan Lee's team at Seoul National University Hospital succeeded in both the safety and securing the necessary blood concentration duration for treatment of "NewGen Nafamostat Tablets" through this Phase 1 clinical trial. Based on these positive clinical results, NewGel Therapeutics plans to conduct Phase 2 clinical trials involving daily oral administration to COVID-19 confirmed patients.

Nafamostat, known as a pancreatic cancer treatment, is a drug proven to have strong antiviral, anti-inflammatory, and antithrombotic effects through research papers and actual treatment cases. Although Nafamostat has been evaluated as difficult to formulate into an oral pill due to its short half-life of only 8 minutes and low persistence, this clinical trial confirmed its potential for success.

Oral treatments can be easily taken even during self-quarantine and are effective in preventing severe cases and reducing hospital admission rates, prompting many pharmaceutical companies to engage in their development. NewGel Therapeutics has participated as a frontrunner in the development of oral treatments.

A representative of NewGel Therapeutics stated, "We consider Nafamostat to be the most potent existing candidate substance for COVID-19 treatment," adding, "Once the development of NewGen Nafamostat Tablets is completed, it can be supplied at less than one-fifth the price of Pfizer's 'Paxlovid,' which is known to cost about 830,000 KRW for a 5-day course, and it is expected to have fewer side effect concerns compared to overseas treatments."

He continued, "Domestic oral treatments are absolutely necessary, and we are also exploring ways to reduce clinical costs through national projects," adding, "As the need for oral COVID-19 treatments has recently increased, the government has promised expedited approval reviews." He further stated, "After completing Phase 2 clinical trials, we will quickly supply the treatment through an 'Emergency Use Authorization' application."

Nafamostat works by first binding to the cell membrane's 'TMPRSS2 receptor,' which binds to the virus's spike protein, thereby blocking viral infection. This mechanism has been confirmed effective against respiratory viruses such as COVID-19, SARS, and MERS. Since the infection pathway is the same for all variant viruses, it is expected to be effective against various mutations.

According to in-vitro experiments by the Pasteur Institute, Nafamostat demonstrated over 600 times greater antiviral efficacy than Remdesivir. Results from actual use on severe COVID-19 patients at Tokyo University in Japan and Dankook University Hospital in Korea have proven clear effectiveness and have been published in research papers.