Pedro A. Muñoz | PharmaMar has just announced positive results for its APLICOV trial with Aplidin against COVID-19. This antiviral achieves the primary safety objective and the secondary efficacy goal, as well as a significant reduction in viral load and C-reactive protein (CRP) in hospitalized patients.
80.7% of patients have been discharged before day 15 of hospitalization, and 38.2% before day 8 (according to the protocol, there must be a minimum admittance period of 7 days). And by day 30, none of the patients had developed symptoms or signs of infection from COVID-19. PharmaMar will soon begin a Phase III registration study.
A few days before this news, the company’s president, José María Fernández Sousa-Faro, gave an interview to The Corner. He spoke about the good results of this drug and the high expectations of it joining the catalogue of Covid-19 mitigating remedies. The commitment to the fight against the pandemic is logically unavoidable for this company. It was created in 1986 as a biotechnology subsidiary of the former Zeltia, which it absorbed in 2015.
Q: During the pandemic, PharmaMar’s focus was on a promising molecule that could serve as a treatment for COVID19, namely plitidepsin. What stage has been reached in research with this molecule and when will the first results be known?
A: Knowing the virulence and dangerousness of the virus we face, PharmaMar could not sit idly by. It looked into its therapeutic arsenal to see what it could do to help curb the pandemic. After some initial in vitro trials with the CSIC and Dr. Luis Enjuanes’ coronavirus laboratory, we observed that plitidepsin acted effectively against the coronavirus by preventing its replication, by blocking the EF1A protein, which is essential for this process. And after several weeks of waiting, the Spanish Agency of Medicines and Healthcare Products authorized us a Phase I/II clinical trial of which we will soon know the results.
Q: In recent weeks, we have read about the announcement of a new unit in the company dedicated entirely to virology…
A: It all comes from the research carried out with plitidepsin to fight the coronavirus. And in view of the challenge to which society is exposed in the event of suffering a new global pandemic which paralyses our economy, our health systems, our behavioural habits… With this aim in mind, we have created a new Virology Unit to research, develop and provide medicines for viral diseases for which there are still no effective treatments. Logic tells us that, as in the case of bacteria with antibiotics, the best antivirals can be found in nature. It is precisely in the sea where most viruses exist – 10 million viruses per milliliter of water – and where they have existed for the longest time. Let’s remember that life began in the sea 3.8 billion years ago and the first inhabitants were bacteria and their viruses. And, coincidentally, PharmaMar is the world leader in the search for drugs with marine origin. That said, it should come as no surprise that plitidepsin is the most powerful antiviral described to date. At the moment, we have the APLICOV-PC clinical trial underway to evaluate the safety and efficacy of plitidepsin at three dose levels. It has been shown in different pre-clinical studies to be effective against SARS-CoV-2 and other types of coronavirus. The results of this first study are expected to be available at the end of October or early November.
Q: Let’s change the subject. PharmaMar has just started trading on the Ibex35 after a year of good results and an over 100 percent appreciation in its share price. What does this mean for the company’s future?
A: Entry into the IBEX 35 follows a year and a half of excellent results and milestones achieved by PharmaMar. The company has another dimension now, completely different. I can assure you that we are currently the world leader in the development of drugs of marine origin. And the company is continuing to grow. That said, it is true that the most significant development for PharmaMar in recent months was that the FDA, the US Drug Enforcement Agency, first granted accelerated approval and later priority review for the treatment of small-cell lung cancer in the second line with Zepzelca (lurbinectedin). This approval represents a historical milestone for the company and a new stage, since nothing had been developed in this field in 25 years.