Repurposed drugs for COVID-19 unveil clinical trial findings

Companies challenged to find participants, considering on going global

Il-yang Pharmaceutical first to announce failed clinical trial, others try to cover up the anxiety

A series of clinical trial results in repurposing already-commercialized drugs for COVID-19 treatment is unveiling one by one, and the outcome seems to be contrasting among the pharmaceutical companies.

 

For some pharmaceutical companies, their highly anticipated clinical trials have failed and the results are affecting different drugs by other companies.

 

The companies without an outcome, yet, are busy covering up the market’s anxiety and concern by presenting interim status report or requesting for authorization.

 

# According to pharmaceutical industry sources on Mar.

 

9, Il-yang Pharmaceutical broke the news that it became the first South Korean company to have failed the clinical trial for repurposing the drug for COVID-19 treatment.

 

The company initiated a Phase III trial on a leukemia treatment Supect (radotinib) to repurpose the drug, but it was unable to confirm the expected effect.

 

With the announcement, the pharmaceutical industry was instantly thrown into turmoil with the stress of uncertainty in a successful drug repurposing trial.

 

To resolve the concern, pharmaceutical companies conducting the clinical trials are reporting their current status with the trial, requesting for conditional approval to the Ministry of Food and Drug Safety (MFDS) and unveiling plans to execute a large-scale Phase III trials with 600 participants.

 

For instance, Shin Poong Pharm unveiled the current progress in the locally conducted Phase II clinical trial on Pyramax (artesunate plus pyronaridine phosphatein) to confirm its effect to treat COVID-19, and explained the company has expanded the number of clinical institutes to accelerate to outstanding process.

 

On top of the 10 healthcare institutes initially conducting the trial, the company added three more institutes including Eunpyeong St.

 

Mary Hospital.

 

But as the plan was finalized under the tight confidentiality, the associated hospitals apparently got the news from the company’s official statement.

 

For the Phase II trial, Pyramax has been administered to 76 patients and Shin Poong Pharm aims to call for another 110 patients.

 

According to the company’s plan, the trial should be completed in April.

 

Moreover, Chong Kun Dang has submitted an application to MFDS of requesting conditional item approval and Phase III trial on Nafabelltan (nafamostat) as a COVID-19 treatment.

 

For the Phase III, the South Korean company also submitted a clinical trial protocol involving 600 participants.

 

Chong Kun Dang official explained, “The Phase III trial targeting about 600 patients in South Korea with severe level of high health risks would be conducted in 10 healthcare institutes including the Seoul National University Hospital.

 

As we are aware of the challenges in calling for patients, the company plans to push global clinical trial to promptly register clinical trial participating patients.” On the other hand, Bukwang Pharm is currently working on repurposing its own hepatitis B virus treatment Levovir (clevudine) as a COVID-19 treatment.

 

Recently, 60 patients participating in a Phase II trial have been administered with the drug, which their data is currently being analyzed.

 

Daewoong Pharmaceutical has also started a Phase III trial on Foistar (camostat mesilate) to confirm its effect to treat COVID-19.

 

The company struggled to get statistically meaningful data during the Phase II trial, but the company is to confirm the drug’s efficacy with a Phase III trial.

 

While the South Korean pharmaceutical companies are dealing with different outcomes of repurposing existing drug and developing COVID-19 treatment, the pharmaceutical industry expects to see the outcomes within this year.

 

A pharmaceutical company employee, who requested to be anonymous, commented, “Many of South Korean pharmaceutical companies are seeking for COVID-19 treatment by repurposing their existing drugs.

 

And we are expecting to see the results within this year.

 

But the companies seem to be heavily burdened by the exceptionally heightened interest from the industry and investors.”