Promomed Group has started an effectiveness and safety trial for the injectable form of Areplivir in patients hospitalized with COVID-19, according to the data of the State Register of Medicines. The company reported that a phase 1 clinical trial of the new dosage form of the drug in various dosages in healthy volunteers has been completed.
“The study will be multicenter and is to last until December this year. We expect the first statistically significant results this autumn, which will give us an opportunity, if the tests are successful, to apply for a temporary registration certificate in accordance with Federal Law 441. This means that full-scale production and delivery to hospitals can start as early as in the third quarter,” the report says.
The group of companies that the benefits of treatment with the injectable form of the drug are still hypothetical. The developers suggest that the new form of the drug has a higher bioavailability (which is important due to the effect of COVID-19 on the gastrointestinal mucosa), provides a more intense and uniform penetration and distribution of the drug in cells, a longer retention of therapeutic concentration, and it can be administered to patients who have difficulty in swallowing tablets or experience adverse symptoms of the gastrointestinal tract.
Promomed specialists do not rule out that the injectable form of Areplivir can be included in the updated version of the Ministry of Health recommendations as it is more convenient and effective for hospitals than the oral form.