Thelma Therapeutics Co., whose Kospi shares are suspended upon receiving disclaimer opinion, has been denied by the local drug authority to proceed with its Phase 3 clinical trial on its investigational Covid-19 cure candidate Neovir-CoV.

Thelma Therapeutics said in its regulatory filing on Monday last week that the Ministry of Food and Drug Safety turned down its application for a multinational phase-3 clinical trial it filed in October to evaluate the safety and efficacy of the repurposed antiviral in patients with moderate Covid-19 symptoms.

Neovir-CoV is an antiviral drug developed by Russian drugmaker Pharmsynthez. The drug has been used overseas for the treatment of viral infections such as herpes zoster, hepatitis B and HIV. Thelma Therapeutics had planned to co-sell the drug with Pharmsynthez.

The company said its Phase 3 IND application had been rejected for having failed to meet some of the requirements set forth by the drug regulator and it is considering reapplying for a Phase 2 clinical trial.

Thelma Therapeutics received a disclaimer of opinion for its 2020 financial statement from an outside auditor last month. Trading of the drugmaker’s shares on the main bourse Kospi has since been suspended.

The company said its contract manufacturing organization (CMO) deal to manufacture Russian Covid-19 vaccine CoviVac is proceeding with no setbacks.

By Lee Soo-min

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]