Spanish pharma company PharmaMar’s cancer drug Aplidin (plitidepsin) has demonstrated ‘potent preclinical efficacy’ against SARS-CoV-2, the virus which causes COVID-19.
A research article, published in the peer-reviewed journal Science, detailed the findings from an in vitro and in vivo study which evaluated the drug’s ability to inhibit the protein eEF1A as a target for the treatment of COVID-19.
Aplidin inhibits the eEF1A protein, which is associated with the SARS-CoV-2 virus, and is approved in Australia as a multiple myeloma treatment.
According to the recently published study, in vitro Aplidin showed antiviral potency against SARS-CoV-2 compared to other antivirals – importantly, with ‘limited toxicity’.
In 2017, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on Aplidin for multiple myeloma.
This was partly due to the frequency of severe adverse events that were associated with treatment with Aplidin plus dexamethasone, compared to dexamethasone alone in multiple myeloma patients.
However, PharmaMar added that while the toxicity is a ‘concern’, the doses used in its COVID-19 clinical trials are well tolerated in humans.
‘This study establishes plitidepsin as a host-targeted anti-SARS-CoV-2 agent with in vivo efficacy,’ the researchers wrote.
‘We believe that our data and the initial positive results from PharmaMar’s clinical trial suggests that plitidepsin should be strongly considered for expanded clinical trials for the treatment of COVID-19,’ they added.
PharmaMar added in a statement that it is discussing the launch of phase 3 trials with different regulatory agencies.
“At first we are not targeting ICU patients, there will be hospitalised patients, but doctors are collaborating with us to identify the different phases a sick person goes through, and determine which would be ideal to focus on to produce the best results we can get from plitidepsin,” Pablo Aviles, PharmaMar’s head of nonclinical toxicology and pharmacology told Reuters TV.