PharmaMar (MSE: PHM) today announced the initiation and recruitment of the first patient in the phase II clinical trial, Nereida [1].

The aim of this study is to evaluate the efficacy of plitidepsin in pre-specified groups of immunocompromised patients with symptomatic COVID-19 requiring hospital care versus controls in terms of mortality and viral load. The study is already approved in Spain, France, Italy, Greece, Hungary, Poland and Portugal, and it is expected that it will be authorized in other countries in the coming months.

PharmaMar launches this study after evaluating the data obtained in compassionate use programs with plitidepsin in more than 70 patients with this same profile, which suggest that this could be a well-tolerated treatment that could have potential antiviral efficacy in immunocompromised patients with COVID -19 [2].

COVID-19 positive immunosuppressed patients have an additional complication, as their own immune system fights to neutralize the virus. These patients suffer a greater burden of symptomatic SARS-CoV-2 infection and severe illness from COVID-19.

The Infectious Diseases Society of America (IDSA) defines immunosuppressed populations as a heterogeneous group of individuals with inherited or acquired immune deficits, affecting multiple compartments of the immune system to varying degrees. Specific immunocompromised populations include HIV and cancer patients, as well as solid organ transplant recipients [3].

Despite advances in the treatment and prevention of SARS-CoV-2 infection in society, effective new antiviral therapies remain useful for hospitalized patients with this disease.

Diego Lopez Mendoza, Director of the PharmaMar Virology Business Unit, has commented: 'Preventive treatments, such as vaccines, and current treatments, have worse results in immunocompromised patients with COVID-19. Plitidepsin has already demonstrated its long-term safety in previous studies, and the data we have seen in cases of compassionate use in this patient profile suggest that plitidepsin could become a therapeutic alternative'.

Contact:

Tel: +34 91 846 6000

Email: pharmamar@pharmamar.com

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