The phase 2 EMPATHY top-line data which is a DARP in therapeutic antiviral used in the COVID-19 treatment suggests that measurable and meaningful benefits were seen from Ensovibep over the placebo. The trial is being conducted by Novartis and has Molecular partners as its sponsor. The EMPATHY as it is called is randomized, placebo-controlled, double blind study, that is useful in cases of non-hospitalised adult patients that are suffering from COVID-19.
The trial in its part A had 407 patients to identify Ensovibep dose with utmost safety and efficacy and had patients from India, South Africa, the Netherlands, Hungary, as well as the US. The participants were given three doses each of 75, 225, and 600mg. The primary finding of the trial suggested the viral load reduction over 8 days. The key secondary endpoints which were a part of the study revolved around emergency room visits or hospitalization to clinical recovery. As per the new data, Ensovibep could meet the primary endpoint with a significant reduction when it came to the viral load.
The data in addition showed that the drug had a significant benefit over the placebo at two secondary endpoints having a decline of 78% in hospitalization or emergency room visits vis-a-vis the placebo.
The group with a placebo had 99 patients with round about 5 patients which needed hospitalization. Of the five two passed away due to COVID complications and one had an emergency room visit. On the other hand, of around 300 patients who got treated with Ensovibep, only two were hospitalised, while two had an ER visit and there were no deaths reported. The doses which were administered were tolerated by patients, thereby not giving any occurrence to safety -elated issues. Apparently, the lowest dose which is 75mg has been planned for further development and the new data will help to further determine the next step of action in the program. With these results, Novartis has said that it will go ahead with the option to seek license of Ensovibep from the sponsors and will also look out for expedited access across the world through USFDA and its emergency use authorization process.
Vas Narasimhan who is the CEO at Novartis opines that the trial is positive and demonstrates a valuable effect of Ensovibep becoming a potential to treat COVID-19. Once the decision is made to go all out, the company will be responsible for manufacturing, the dose’s development, distribution, etc. Scaled-up activities have already been initiated by Novartis in its production facilities. To inactivate the COVID-19 Virus, Ensovibep is a therapeutic candidate. The DARPins in it have mono or therapies which are multi specific protein based needed to engage with the targets.
