Eli Lilly & Company ( LLY Quick Quote LLY - Free Report) announced that it has submitted an initial request to the FDA for granting Emergency Use Authorization (EUA) for its antibody therapy candidate, LYCoV555, as a monotherapy for the treatment of higher-risk patients, who have recently been diagnosed with mild-to-moderate COVID-19. Lilly also said that, if approved, it can make as many as one million doses of LY-CoV555 monotherapy (700 mg dose) available this year with 100,000 available in October.
The request for EUA was based on data from both the monotherapy cohort as well as the combination cohort of the phase II BLAZE-1 study on LYCoV555. Lilly released new interim data from a combination cohort of BLAZE-1 study evaluating a combination of two of Lilly’s antibody therapy candidates, LYCoV555 and LY-CoV016, for the treatment of symptomatic COVID-19 in the outpatient setting along with the latest press release. However, the monotherapy data was released last month.
The combination cohort enrolled recently diagnosed patients with mild-to-moderate COVID-19, who were given 2800 mg each of LYCoV555 and LY-CoV016 or placebo. The combination therapy data showed that the antibody combination reduced viral load symptoms and COVID-19-related hospitalization and emergency room visits. The combination therapy significantly reduced viral load at day 11, thereby meeting the study’s primary endpoint. The dual antibody therapy also reduced viral levels at day 3 and day 7— earlier time points during the course of infection. The rate of COVID-19-related hospitalization and emergency room visits was 0.9% for the patients treated with the dual antibody, lower than 5.8% for placebo.
Lilly is developing LYCoV555 (monotherapy) in collaboration with private biotech AbCellera while it licensed LY-CoV016 from China-based Junshi Biosciences. Junshi leads the development of LY-CoV016 in Greater China, while Lilly is taking care of development in the rest of the world.
Lilly said it will file a separate request for EUA for the combination therapy in November, once additional safety data is available, and expects to have enough data to file a formal biologics license application (BLA) to the FDA in the second quarter of 2021. It said that it can have 50,000 doses of combination therapy available in the fourth quarter.
Lilly’s stock was up 3.35% in response to the news. In fact, so far this year, Lilly’s stock has risen 13.4% compared with a decrease of 2.3% for the
Meanwhile, the BLAZE-1 study includes another cohort evaluating the antibody combination in higher-risk patients recently diagnosed with mild-to-moderate COVID-19. Additionally, Lilly is conducting a separate phase III study on LYCoV555 for the prevention of COVID-19 at nursing homes which began in August. LY-CoV555 is also being tested in the National Institutes of Health-led ACTIV-2 and ACTIV-3 studies of ambulatory and hospitalized COVID-19 patients.
Meanwhile, Lilly has completed a phase I study on LY-CoV016 for treating COVID-19.
Lilly is also conducting a phase III study to evaluate its JAK inhibitor, Olumiant (baricitinib) as a potential treatment for hospitalized patients diagnosed with COVID-19. Another study evaluating a combination of Olumiant with Gilead’s (
GILD Quick Quote GILD - Free Report) remdesivir is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) for hospitalized patients with COVID-19 infections. In September, Lilly announced that the study met the primary endpoint by showing that Olumiant plus remdesivir led to a reduction in time to recovery in comparison with remdesivir.
Several other companies are also working on developing new antibodies to combat the deadly COVID-19 disease.
REGN Quick Quote REGN - Free Report) , REGN-COV2, a novel investigational antibody "cocktail" treatment, is currently being studied for the treatment of hospitalized patients, and for the prevention of infection in people who have been exposed to COVID-19 patients. Last month, Regeneron announced promising first data from a seamless phase I/II/III study which showed that the candidate reduced the viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. In-fact, REGNCOV2 was recently administered to President Donald Trump as he tested positive for COVID-19. Trump, in a video posted on Twitter on Wednesday, said that REGNCOV2 was the “key” to his recovery.
Vir Biotechnology (
VIR Quick Quote VIR - Free Report) and Glaxo’s investigational monoclonal antibody, VIR-7831, entered phase III portion recently for the early treatment of COVID-19 in patients, who are at high risk of hospitalization. The phase II/III study has two other cohorts, one for the treatment of hospitalized patients and another for the prevention of symptomatic infection. A phase II study on another monoclonal antibody VIR-7832 is expected to begin soon.
Lilly currently carries a Zacks Rank #2 (Buy). You can see
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