PharmaMar has reported that their Aplicov-PC clinical trial with Aplidin (plitidepsin) for the treatment of adult patients with Covid-19, who require hospital admission, has met the primary safety and secondary efficacy objectives. The company has risen this Friday just over 3% after skyrocketing 11%.
Three cohorts of patients with three different dose levels of plitidepsin (1.5mg – 2.0mg – 2.5mg), administered for three consecutive days, have been evaluated in the study.
PharmaMar will begin talks with regulatory agencies in the coming days to define the next phase III study
The viral load of the patients was quantitatively and centrally assessed at the start of treatment and on days 4, 7, 15 and 30 thereafter. The study has shown "a marked reduction in viral load" in patients between days 4 and 7 after starting treatment, so that the average reduction in viral load on day 7 it was 50%, and 70% on day 15. More than 90% of the patients included in the trial had medium or high viral loads at the beginning.
80.7% of the patients have been discharged from hospital on or before day 15 of hospitalization, and 38.2% before day 8 (according to the protocol, they must be hospitalized for a minimum of 7 days).
Likewise, PharmaMar has explained that it is observed a remarkable parallelism between the decrease in viral load, clinical improvement and resolution of pneumonia, as well as a drop in inflammation parameters, such as C-reactive Protein (CRP).
By day 30, in the scheduled clinical visit, none of the patients treated with plitidepsin had developed symptoms or signs derived from Covid-19 infection.
This results confirm both safety and activitythe company has said. Safety has already been seen in other studies, with approximately 1,300 cancer patients treated at much higher doses, and the activity has already been seen in in vitro and in vivo studies in different internationally renowned laboratories.
Following the results obtained in this first group of patients, in order to keep the study open in hospitals, to allow access to treatment to those patients who need it, the company has obtained from the Spanish Agency for Medicines and Health Products (AEMPS ) authorization for an extension of the patient cohort. This, in addition, will allow to obtain more data on the treatment in this indication.
With this data, the company will begin conversations with regulatory agencies in the coming days. to define the next phase III study of plitidepsin registry in patients with Covid-19 who require hospitalization.
The complete data of the study will be published in future scientific conferences and / or in an article in a prestigious medical journal.
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