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Summary
- Indiana-headquartered pharmaceutical giant Eli Lilly paused the late-stage trial of its investigational antibody treatment against COVID-19 due to unspecified safety concerns.
- Earlier this month, Eli Lilly was applying for emergency use authorization (EUA) for LY-CoV555, antibody-drug against COVID-19.
- In a video published on Twitter on 8 October, US President Donald Trump touted the investigational monoclonal antibody treatments by Eli Lilly and Regeneron.
The clinical trial of pharmaceutical company Eli Lilly and Company’s antibody COVID-19 treatment was paused because of some potential safety concerns. Eli Lilly announced trial halt just a day after Johnson & Johnson disclosed the pause of its COVID-19 vaccine trial because of a sick participant. Post the announcement of trial halt, the share price of Eli Lilly closed at US$150.08 down by 2.85% on 13 October 2020.
Monoclonal antibody treatments have been gaining attention after US President, Donald Trump received one of the monoclonal antibody treatments by biotech company Regeneron for his treatment.
Let us discuss in detail-
Donald Trump ballyhoos investigational monoclonal antibody treatments by Eli Lilly and Regeneron
On 7 October 2020, President Donald Trump, who was earlier tested positive for coronavirus, stated that new rules by the FDA had made fast-track development of COVID-19 vaccines for approval before Election Day more difficult highlighting it as just a new ‘political hit job’.
In a video posted on Twitter, other than discussing COVID-19 vaccines, the President also promoted investigational monoclonal antibody treatments from biotech player Regeneron and pharmaceutical company Eli Lilly.
Mr Trump highlighted that during his course of treatment against COVID-19, he was given an 8gm dose of REGN-CoV-2, Regeneron’s antibody cocktail. He also added that he felt good immediately after administration of the antibody cocktail.
Related to Eli Lilly and Regeneron’s potential treatments, Donald Trump highlighted that the administration is trying to get them on an emergency basis. Trump said the administration is set to grant emergency use authorization (EUA) to these treatments. However, the CEO of Regeneron, Leonard Schleifer, stated that the COVID-19 drug requires more testing and that Mr Trump’s case is just a single case.
Image Source: © Kalkine Group 2020
For COVID-19 vaccine, Trump highlighted that investigational vaccines from Johnson & Johnson and Moderna are on track. However, recently, Johnson & Johnson disclosed that the Company paused its COVID-19 vaccine candidate’s clinical trials after a participant developed an unknown illness.
ALSO READ: Trump boasts of pushing FDA to deliver, Claims Vaccine to Come out Shortly
Eli Lilly Halts its trial for COVID-19 antibody treatment
A global health care leader Eli Lilly and Company (NYSE:LLY) is into the discovery and development of therapies or medicines that make life better for people across the world. Currently, the Company is developing an antibody-based therapy for the prevention and treatment of COVID-19.
On 13 October 2020, Eli Lilly stated that the enrollment of volunteers for the clinical trial of its antibody treatment for COVID-19 was stopped because of a potential safety concern.
Earlier, on 7 October 2020, the Company had provided a thorough update on the progress of neutralizing antibody programs for SARS-CoV-2. LLY said that it had submitted a request for EUA for LY-CoV555 monotherapy to FDA.
The ACTIV-3 monoclonal antibody treatment trial is under Phase 3 and has been paused due to some potential safety issues. The Phase 3 trial is a study on hospitalized COVID-19 patients and was started in August 2020 across more than 50 clinical sites.
Moreover, Eli Lilly stated that it is prepared to supply almost 1 million doses of LY-CoV555 monotherapy and nearly 50,000 doses of combination therapy of LY-CoV555 and LY-CoV016 in the fourth quarter of 2020. The Company said that it would increase combination supply substantially in the first quarter of 2021.
Lilly signed an agreement to Supply Potential COVID-19 antibody treatment to low & middle-income nations
On 8 October 2020, Eli Lilly and the Bill & Melinda Gates Foundation signed an agreement for facilitating access to upcoming Lilly therapeutic antibodies which are under development for the prevention and treatment of COVID-19 to benefit low- and middle-income nations.
This attempt for the equitable access to novel treatments is part of the COVID-19 Therapeutics Accelerator (CTA), which was developed to fast-track the development of and access to COVID-19 treatments. The Company stated that commercial manufacturing would commence in April 2021 in Denmark at the FUJIFILM Diosynth Biotechnologies facility.
DO READ: How are developing world economies preparing for COVID-19 vaccine deployment and testing?
Bottomline
Healthcare sector is in a race against time to develop a potential treatment or a vaccine for the ongoing COVID-19 pandemic. Healthcare companies are accelerating clinical trials to find a solution as soon as possible.
Despite an urgent need of finding a treatment or cure, it is not uncommon to pause a clinical trial if there are safety concerns that might require further investigation. With human health as the foremost concern, clinical trials must be performed under intense scrutiny. Keeping in mind that the safety of millions could be at stake, it is imperative that companies thoroughly investigate any adverse outcomes.
