Thelma Therapeutics Co. has submitted an investigational new drug (IND) application to France’s health authorities (ANSM) for a Phase 3 clinical trial of its Covid-19 cure candidate Neovir-CoV, the company said on Tuesday.
The South Korean pharmaceutical company plans to evaluate the safety and efficacy of the repurposed antiviral in patients with moderate symptoms in a broad spectrum of races and ethnicities during a Phase 3 trial in France. It already submitted a Phase 3 IND application in Korea last October.
Kospi-listed Thelma Therapeutics rose 1.99 percent to close at 8,200 won ($7.37) on Wednesday.
Neovir-CoV is immunotherapy known to effectively block virus proliferation by activating the body’s immune system, which acts as a primary defense barrier against virus establishment. It induces interferon production, thereby inhibiting cell transformation caused by coronavirus infection and gene expression involved in virus growth, explained the company.
Interferon is a substance that regulates the immune system. Thelma therapeutics said that several clinical trials have revealed that the amount and activity of interferon are associated with exacerbation of coronavirus.
The drug has been used overseas for the treatment of viral infections such as HIV and HCV. In the Phase 3 trials in Covid-19 patients with moderate symptoms, the company hopes to see a significant reduction in the disease progression to severity through recovery of symptoms in the early and mid-stage infection.
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