MFDS to support Phase III trials of domestic COVID-19 Txs

Held 16 councils in 2H to support domestic companies including Chong Kun Dang, Daewoong Pharmaceuticals, etc.

The meeting were held to support COVID-19 treatment candidates…. “Will make efforts to address the companies’ difficulties in addition to approval review support."

The Ministry of Food and Drug Safety has been supporting domestic companies that have entered Phase III trials for their domestic COVID-19 treatments through its ‘Development-focused Support Council.' The three items currently approved for Phase III trials and supported by the Support Council are: Chong Kun Dang’s ‘Nafabeltan (nafamostat),’ Daewoong Pharmaceutical's ‘Foistar(camostat),’ and Shin Poong Pharmaceutical’s ‘ Pyramax (pyronaridine/artesunate).’ The news was shared at an ‘Online briefing session regarding 2021 2H drug reviews ’ that MFDS held on the 3rd.

 

Kyung-sook Choi, a researcher of the Oncology and Antimicrobial Products Division, said, “We have been operating a Development-focused Support Council since earlier this year to address the difficulties faced by domestic developers (of COVID-19 treatments) that are entering Phase III trials.” After completing the Phase II trial for ‘Nafabeltan,' Chong Kung Dang had applied for conditional approval earlier this year but was turned down in February.

 

However, the company continued its pursuit and received approval for a Phase III trial in April and started the trial in July.

 

Chong Kung Dang plans to conduct its clinical trial in Korea and 7 other countries - Ukraine, Argentina, India, Russia, Brazil, Peru, Thailand.

 

In the Phase III trial, the company will enroll 600 patients with severe COVID-19 to verify the efficacy of its treatment candidate.

 

Daewoong Pharmaceutical has been developing its Foistar tablet under the trademark name ‘Coviblock’ as a COVID-19 treatment.

 

The Phase III trial protocol for the substance, DWJ1248, was approved twice - on December 31st last year and in January this year.

 

Although the drug failed to meet the primary endpoint and reach statistical significance in its Phase II trial, its potential as a treatment still remains as the drug had shown to expedite recovery in patients who have a higher risk of progressing to severe COVID-19.

 

The Phase III trial protocol for Shin Poong Pharmaceutical’s Pyramax tablet was approved last August.

 

Like the other new drug candidates from Chong Kun Dang and Daewoong Pharmaceutical, Shin Poong Pharmaceutical’s Pyramax also failed to meet statistical significance for its primary endpoint in its Phase II trial.

 

However, the drug also showed potential in reducing the rate of progression to severe COVID-19, based on which the company initiated a large-scale Phase III trial.

 

The company plans to recruit around 1,400 participants for the trial.

 

All three domestic COVID-19 candidates are repurposed drugs that were used to treat other diseases in the past.

 

Chong Kun Dang’s Nafabeltan inj.

 

was a blood anticoagulant, Daewoong Pharmaceutical's Foistar a treatment for chronic pancreatitis and reflux esophagitis, and Shin Poong Pharmaceutical’s Pyramax an antimalarial drug.

 

The MFDS explained that it had held 16 Development-focused Support Council meetings to support the smooth progress of the companies' clinical trials.

 

Choi said, “We first held meetings once a week, but then changed to a twice a week schedule.

 

The council not only supports issues related to approval and reviews but also helps companies resolve non-MFDS issues by sharing such issues with the pan-government support group." The MFDS had shortened the clinical trial period for COVID-19 treatments from the previous 30 days to 7 days (15 days for new drugs) and organized an exclusive review team to shorten the review and approval process from the previous 180 days to 40 days.

 

Currently, a total of 34 COVID-19 treatment candidates have entered clinical trials, including 25 antivirals (18 repurposed drugs, 7 new substances) and 9 immunomodulators (7 repurposed drugs, 2 new substances).

 

Choi said, “We are doing our best to meet our promised deadline through priority and expedited review systems for COVID-19 treatments.

 

We ask for your understanding as this may delay complaints filed for non-COVID-19 treatments."