Thelma Therapeutics¡¯ Phase 3 IND for Covid-19 cure rejected in Korea

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.

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