[News]PharmaMar announces positive results of its Aplicov trial against Covid-19

[SougarLord]

 

PharmaMar has announced that its Aplicov-PC clinical trial, with Aplidin (plitidepsin), for the treatment of adult patients with Covid-19, requiring hospital admission, has achieved the primary safety and secondary efficacy objectives.

 

Specifically, as the company explained, the study evaluated three cohorts of patients with three different dose levels of plitidepsin (1.5 mg, 2 mg and 2.5 mg), administered for three consecutive days and the load The viral load of the patients has been quantitatively and centrally evaluated at the start of treatment and on days 4, 7, 15 and 30 thereafter.

 

The study has shown a notable reduction in viral load in patients between days 4 and 7 after starting treatment, such that the average reduction in viral load on day 7 was 50%, and 70% on day fifteen.

 

More than 90% of the patients included in the trial had medium or high viral loads at the beginning.

80.7% of the patients were 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, according to the firm, a notable parallel is observed between the decrease in viral load, clinical improvement and the resolution of pneumonia, as well as a fall 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.

 

PharmaMar has highlighted that these results confirm both safety and activity.

 

"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," says the firm. .

 

After the results obtained in this first group of patients, in order to keep the study open in hospitals, 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, in the coming days, conversations with regulatory agencies to define the next phase III study of plitidepsin registration in patients with Covid-19 who require hospitalization.

 

The firm has indicated that the complete data of the study will be published in future scientific conferences and / or in an article in a prestigious medical journal.