Eli Lilly & Company’s LLY late-stage ACTIV-3 study evaluating a combination of its monoclonal antibody candidate, LYCoV555, for the treatment of coronavirus has been paused, as reported in a CNBC article. The U.S. Government’s National Institute of Health (“NIH”) was leading the study and decided to pause following potential safety concerns raised by the independent data safety monitoring board. This study is part of NIH’s Activ program that has been designed to accelerate the development of COVID-19 vaccines and treatments. Further, enrolment in the study has also been paused.
Please note that the study is evaluating LYCoV555 in combination with Gilead’s GILD antiviral drug, remdisivir, in hospitalized COVID-19 patients.
However, details of safety issues are yet to be known. Medical experts note that such adverse events are part of clinical studies, especially large ones. However, only a small number of patients have been treated with LYCoV555 so far, which can result in ambiguity as the data may not be able to provide clarity.
Lilly’s stock has gained 14.2% so far this year compared with the industry’s increase of 0.9%.
The news on Lilly’s study halt is a major disappointment amid rising concerns regarding a second wave of COVID-19 infection. Although no other clinical study evaluating a coronavirus treatment has been paused, two major coronavirus vaccine studies have been paused recently. Earlier this week, J&J JNJ paused dosing in all clinical studies on its coronavirus vaccine candidate, JNJ-78436735, due to an unexplained illness observed in a study participant. J&J is also reviewing the study data. AstraZeneca AZN has voluntarily paused its global coronavirus vaccine studies last month after a patient in the U.K. study suffered an unspecified illness. Although clinical studies have resumed in many countries, the U.S. study is under clinical hold.
Meanwhile, we note that Lilly is also evaluating LYCoV555 in other clinical studies for treating COVID-19 in different treatment settings. Earlier this month, the company submitted an initial request to the FDA for granting Emergency Use Authorization (EUA) for LYCoV555 as a monotherapy for the treatment of higher-risk patients who have recently been diagnosed with mild-to-moderate COVID-19. The request for EUA was based on data from both the monotherapy cohort and the combination cohort of the phase II BLAZE-1 study on LYCoV555. The combination cohort evaluated a combination of Lilly’s antibody therapy candidates, LYCoV555 and LY-CoV016, for the treatment of symptomatic COVID-19 in the outpatient setting as well as mild-to-moderate recently diagnosed COVID-19 patients.
Meanwhile, Lilly has completed a phase I study on LY-CoV016 for treating COVID-19. Lilly is also developing its JAK inhibitor, Olumiant, as monotherapy or in combination with remdisivir as a potential treatment for hospitalized patients diagnosed with COVID-19.
In addition to Lilly, Regeneron and AstraZeneca are developing their individual cocktail antibody candidates for prevention or treatment of COVID-19. Regeneron has also submiited a request for EUA. An accelerated development of coronavirus treatment or vaccines is necessary to contain the spread of infection, which has already killed more than a million across the globe.
Lilly currently carries a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Click to get this free report Johnson Johnson (JNJ) : Free Stock Analysis Report AstraZeneca PLC (AZN) : Free Stock Analysis Report Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research