Aplidin . The FDA Just Approved The first Coronavirus Drug – But This New Medicine Might Be Even Better .

 By Chris Smith  / October 25th, 2020 .

*.- Researchers tested a cancer drug called plitidepsin as a coronavirus therapy and discovered it can block the virus’s ability to replicate.

*.- The use of plitidepsin reduced viral loads after just seven days and improved blood test markers for inflammation.

*.- Nearly 40% of a limited group of patients who received various doses of plitidepsin were discharged after just eight days in the hospital.

Doctors looking to devise therapies that can cure patients infected with the novel coronavirus have tried all sorts of existing drugs to prevent the virus from spreading inside the body. Repurposing other drugs is a practice that yielded a few immediate results. For the time being, remdesivir and dexamethasone are the only drugs that have been shown to hasten COVID-19 recovery, with remdesivir being the first coronavirus COVID-19 drug to receive FDA approval. Blood thinners are also common coronavirus therapies to prevent blood clotting that can impact multiple organs. Other drugs weren’t as successful, including the controversial hydroxychloroquine and other therapies that looked promising in the early months of the pandemic.

Researchers from Spain think they have a different drug on their hands that might work even better than remdesivir against the novel coronavirus. It’s called Aplidin (plitidepsin) and it’s used in cancer therapy. Research so far has shown that the drug has antiviral effects, preventing the coronavirus from multiplying after it infects cells. As a result, plitidepsin can significantly reduce recovery time and help hospitals manage their increasing COVID-19 caseloads.

 The Drug is About To Begin Its Phase 3 Trial.

The researchers used plitidepsin on 27 patients with severe forms of COVID-19, Spanish news site La Vanguardia reported a few days ago. Nearly 40% of the patients in the study improved substantially, and they were discharged after eight days. Almost 81% of the patients were discharged by day 15. None of the patients developed any additional signs or symptoms of COVID-19 by day 30.

Aged 18-85, the patients were recruited in 10 hospitals across Catalonia, Madrid, and Castilla La Mancha. The patients were divided into three groups (1.5mg, 2.0mg, and 2.5mg plitidepsin) and had various parameters tested, including viral loads and inflammation markers.

The viral load was reduced by 50% after one week of treatment and 70% after 15 days. Inflammation parameters were also reduced (C-reactive protein), according to the report.

Plitidepsin binds to a human protein that the virus needs to replicate, EF1A. When it does, the coronavirus can’t multiply as efficiently, and it can’t spread through the body. The paper suggests that the drug might be especially useful in the early days of the infection to prevent the virus’s rapid proliferation that can lead to severe COVID-19 cases. The drug was initially synthesized from the Aplidium Albicans species, but it’s now produced synthetically.

“In addition to shortening the evolution time of the disease, our goal was to rapidly reduce the viral load in order to avoid the sequelae suffered by many patients who suffer from Covid months later, such as fatigue,” PharmaMar general director Luis Mora told the paper. “And at the moment, it seems that this molecule succeeds.”

The company will move to a Phase 3 trial that will start in the coming months, enrolling thousands of volunteers. Spain was one of the main COVID-19 hot zones in Europe in the spring but managed to reduce the spread significantly by summer. 

The country is now experiencing a resurgence of the virus, much like the rest of the continent, and it recently surpassed more than one million confirmed COVID-19 cases.

Other scientists have also studied plitidepsin, with three other teams looking at the molecule in lab tests. Plitidepsin was able to inhibit the replication of the novel coronavirus in vitro much better than remdesivir, according to findings from the Coronavirus Laboratory of the National Center for Biotechnology (CNB). The Institute for Emerging Pathogens at Mount Sinai Hospital in New York also studied the substance and found that it only took a small dose to work, which would make it non-toxic to humans. Finally, the Barcelona Supercomputing Center (BSC-CNS), IrsiCaixa, and CReSA compared plitidepsin to dozens of other molecules that might inhibit SARS-CoV-2. They found that plitidepsin was “the one with the strongest antiviral activity against the coronavirus.”

La Vanguardia notes that the results of its plitidepsin testing so far were published on the same day the WHO Solidarity trial results were released. PharmaMar announced the findings in a press release, while the release of the full study is still pending.