US government officials have called off the clinical trial of Eli Lilly antibody-drug after officials confirmed that the drugs won’t help patients that had severe cases of coronavirus. Researchers from the National Institutes of Health (NIH) had initially paused the trial when safety concerns were raised.
An important factor to note is that the drug didn’t endanger patients when administered, which means that they could be used for other treatment modalities.
While it has now been established that the drug won’t help patients suffering from extreme COVID-19 infection, other trials will be continued to help establish the potency of the drug during the early stages of infection. Interestingly, the drug did not fail-safety concerns during tests in hospital settings, which means that its manufacturers could seek emergency authorization in order to use it on patients outside of the hospital.
An independent monitoring board constituted by the National Institute of Allergy and Infectious Diseases, an arm of the NIH, had on October 13, recommended that the trial be paused due to safety concerns. However, after numerous safety tests were conducted, the board found that the drug posed no safety risks amongst patients on which it was administered, Yahoo News writes.
There were concerns earlier on, that the hospital trial may have generated safety concerns that may affect the trial of the drug outside of the hospital, where the drug showed a lot of promise. It is safe to assume none of those concerns were genuine.
A lot of pharmaceuticals are in the race to develop an effective antibody therapy that will be able to mitigate the spread of the coronavirus. These companies, including the likes of Regeneron Pharmaceuticals Inc., AstraZeneca Plc, GlaxoSmithKline Plc, and partner Vir Biotechnology Inc., have shown promising results with their proposed vaccines.
President Donald Trump had the chance to use Regeneron’s experimental antibody therapy when he came down with the coronavirus. Having seen promise in its drug, the company had approached the Food and Drug Administration (FDA) to grant it emergency use authorization.
The ACTIV-3 trial was sponsored to test the effectiveness of the drug developed by Lilly in collaboration with AbCellera Biologics, a Canadian firm. The drug was tested alongside Remdevisir. When there were no signs that the drug produced expected results, further trials were quickly halted. A total of 326 COVID-19 patients had participated in the test.
While a hospital trial may have turned out disappointing, a trial outside of the hospital way back in September had shown some promise. It was on that basis that the FDA was approached for an emergency use authorization on patients who showed mild to moderate symptoms.
Now, it’s been established that monoclonal antibodies become effective only when they are administered early enough in the course of an infection.
Source: bloomberg.com
