NewG Lab Advances Napamostat Injection to Phase 2 and Enters Phase 1 for Oral Tablet

[Asia Economy Reporter Hyunseok Yoo] Newgelab announced on the 4th that its subsidiary Newgen Therapeutics has received approval from the Ministry of Food and Drug Safety (MFDS) for the domestic clinical phase 1 trial (IND) of the oral COVID-19 treatment drug ‘Newgen Nafamostat Tablets’ developed by the company. With this clinical approval, Newgelab will simultaneously conduct two clinical trials for the nafamostat-based COVID-19 treatment.

While the existing phase 2 clinical trial of the nafamostat injectable formulation is being conducted jointly with Gyeongsang National University, the oral formulation is being developed and clinically tested solely by Newgen Therapeutics. This clinical trial will be conducted by Professor Seunghwan Lee’s team at Seoul National University Hospital Clinical Trial Center, aiming to demonstrate tolerability and safety in about 30 healthy subjects.

Newgen Therapeutics plans to conduct the phase 1 oral formulation trial domestically, and from phase 2 onwards, clinical trials will be conducted not only in Korea but also in overseas countries where patient recruitment is faster and easier. Considering that 90% of all COVID-19 patients are mild to moderate cases, the clinical trials will target mild to moderate patients.

Hanshin Young, Head of Clinical Division at Newgen Therapeutics, said, “Just as the fear of H1N1 disappeared with the development of Tamiflu, we hope that the development of nafamostat pills will help everyone overcome the fear of COVID-19,” adding, “We will focus on proving the antiviral effects of nafamostat revealed in previous preliminary studies through clinical trials.”

He continued, “Considering that most COVID-19 patients are mild to moderate cases, the economic value of the oral tablet market is expected to be much greater than that of injectable formulations.”

Meanwhile, Newgelab is also conducting a phase 2 clinical trial of the intravenous nafamostat formulation for severe COVID-19 patients in collaboration with Professor Inkyu Bae’s team at Gyeongsang National University. Once phase 2 is completed, they plan to apply to the MFDS for emergency use approval for use in severe patients.