PharmaMar begins the Nereida clinical trial with plitidepsin for treating immunosuppressed patients with COVID-19

PharmaMar (MSE:PHM) has announced today the initiation and recruitment of the first patient in the Nereida Phase II clinical trial[1]. The objective 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 trial is already approved in Spain, France, Italy, Greece, Hungary, Poland and Portugal, and is expected to be authorized in other countries in the coming months. PharmaMar is launching this study after evaluating the data obtained in compassionate use programs with plitidepsin in more than 70 patients with this profile, which suggest that this could be a well-tolerated treatment, with potential antiviral efficacy in immunosuppressed patients with COVID-19[2]. Immunosuppressed COVID-19 positive patients have an additional complication, as their own immune system struggles to neutralize the virus. These patients suffer an increased burden of symptomatic SARS-CoV-2 infection and severe COVID-19 disease. The Infectious Diseases Society of America (IDSA) defines immunocompromised populations as a heterogeneous group of individuals with inherited or acquired immune deficits, which affect multiple compartments of the immune system to varying degrees. Some specific immunocompromised populations include with HIV and cancer as well as solid organ transplant recipients[3]. Despite advances in the treatment and prevention of SARS-CoV-2 infection worldwide, new effective antiviral therapies are still helpful for hospitalized patients with this disease. Diego López Mendoza, Head of PharmaMar’s Virology Business Unit, said: “Vaccines and current treatments, have worse outcomes in immunocompromised patients with COVID-19. Plitidepsin has already been shown in previous studies to be safe in the long term, and the data we have seen in compassionate use cases in this patient profile suggest that plitidepsin could become a therapeutic alternative.“ [1] ClinicalTrials.gov Identifier: NCT05705167 [2] Outcomes and Clinical Characteristics of the Compassionate Use of Plitidepsin for Immunocompromised Adult Patients with COVID-19: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4316842 [3] ISDA. Immunocompromised Populations: https://www.idsociety.org/covid-19-real-time-learning-network/special-populations/immunocompromised-populations/

The release as fetched from its publisher. pharmamar.com ↗