Eli Lilly’s COVID-19 Antibody trial; Approval for Oriahnn; Gilead’s Remdesivir Clinical Trials result; Russia approves Avifavir to treat Covid-19

Eli Lilly and AbCellera announced the dosing of the patients suffering from COVID-19 with antibody candidate – LY-CoV555. 

LY-CoV555 is a neutralizing IgG1 monoclonal antibody (mAb) that targets the spikes of the proteins of SARS-CoV-2. So far, COVID-19 has taken the lives of more than 372,000 people globally. 

The antibody was developed by Lilly after the successful identification of it through the AbCellera’s rapid artificial intelligence-based pandemic response platform from one of the US patients who managed to recover from the COVID.

The antibody blocks the entry and linking of the viral particles to human cells and prevents the disease. Since the antibody is derived from the blood of a recovered patient, the company claims it to be the potential new medicine specifically designed to attack SARS-CoV-2. 

Moreover, Lilly is planning to test the antibody along with several others, as a monotherapy as well as in combinations, in the coming next months. 

AbbVie has received the recommendation for its oral treatment Oriahnn to treat heavy menstrual bleeding due to uterine fibroids. 

In the first-of-kind approval, the company has won the approval for its oral drug, Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), which has been developed by AbbVie jointly with Neurocrine Biosciences. 

The drug, an oral combination of elagolix and E2/NETA (estradiol/norethindrone acetate), has been developed to regulate and control heavy menstrual bleeding due to uterine fibroids in premenopausal women. The traditional approach to treat the heavy bleeding involved surgery, which is the leading cause of hysterectomies.

Earlier the duo captured the approval for their elagolix for the treatment for endometriosis-associated pain.

Gilead Sciences reported the results of a Phase III trial study evaluating the efficacy and safety of Remdesivir in moderate COVID-19 patients.

The company revealed the results after 5-day and 10-day courses of treatment with the antiviral drug plus standard-of-care, and the results were positive against standard-of-care alone. 

In a 5-day course, patients were 65% more likely to see clinical improvement at 11 days compared to those treated with standard-of-care only. Whereas, on Day 11, a higher proportion of patients in the 5-day treatment group achieved improvement in clinical status versus the standard of care group, achieving statistical significance.

According to the company, three randomized clinical trials with remdesivir in COVID-19 are there, and the trials demonstrated remdesivir’s improved clinical outcomes by several different measures.

Russia’s Ministry of Health gave an emergency use approval for Avifavir to fight SARS-CoV-2 infections.

Originally manufactured to fight severe forms of influenza, Avifavir under clinical trials showed efficacy and safety in disrupting the reproductive mechanisms of COVID-19. 

The drug has already been approved for influenza in Japan in 2014, so its safety is well established and studied and recently the Russian health authority has given the green signal to antiviral drug Avifavir against coronavirus, and is set to proceed for wider clinical trials in up to 330 COVID-19 patients in Russia. 

Now, the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and the ChemRar Group are geared up to deliver 60,000 courses of Avifavir to Russian hospitals in June.