Candidate: Aplidin® (plitidepsin)
Type: Anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programmed death).
Status: PharmaMar on April 28 said it launched the Phase II APLICOV-PC clinical trial of Aplidin in patients with COVID-19 following authorization by the Spanish Medicines and Healthcare Products Agency (AEMPS). The multicenter, randomized, parallel, open-label study to evaluate the safety profile and efficacy of three doses of plitidepsin in patients with COVID-19 requiring hospital admission.
Three hospitals in Madrid will participate in the study. During the study’s first stage, 27 patients will be recruited, to whom three doses will be administered. The viral load of the patients will be measured before and after the treatment, as well as a series of other parameters for clinical evolution. If results are positive, the trial would continue at the optimal dose after discussion with the regulator, with a larger cohort of patients.
In March, PharmaMar announced the results of in vitro studies of plitidepsin in human coronavirus HCoV-229E, with a mechanism of multiplication and propagation that is very similar to that of SARS-CoV-2. The studies were carried out at the National Biotechnology Centre of the Spanish National Research Council (CSIC; Centro Nacional de Biotecnología). The studies confirmed that the therapeutic target of Aplidin, EF1A, is key to the multiplication and spread of the virus.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: