The pharmaceutical company Eli Lilly was the last to temporarily suspend one of its clinical Covid-19 studies. The phase III trial, which included experimental antibody treatment for patients with viral diseases and was sponsored by the federal government, was suspended due to a “potential safety concern,” according to government emails receive from the New York Times Tuesday afternoon.
According to the NYT, government officials sent emails Tuesday informing scientists involved in the process of the break. The emails reportedly urged researchers to “cautiously” stop recruiting new volunteers. Eli Lilly separately confirmed the hiatus in a statement, the NYT reported.
The randomized, double-blind, placebo-controlled clinical trial known as the ACTIV-3is said to include 10,000 volunteers who have been hospitalized with covid-19. Those in the treatment group would receive an IV infusion of the experimental, laboratory-made antibody cocktail called LY-CoV555 in addition to standard treatment (that standard treatment would include the antiviral drug remdesivir, which has shown promise in reducing disease duration). . It is hoped that these monoclonal antibodies can safely boost the body’s natural immune response to infection and prevent or reduce severe symptoms.
The decision to abandon the process comes less than a month after the company had reported promising but preliminary data from previous, smaller antibody treatment studies. These data found that people with mild to moderate Covid-19 who were given the antibody were less likely to be hospitalized or visited the emergency room than those who received the placebo. It also appeared to determine that the treatment was not associated with serious adverse events.
It is currently unknown which safety concerns exactly led to this test stop and how many volunteers it could affect. Neither Eli Lilly nor the National Institutes of Health responded to a request for comment from Gizmodo.
Eli Lilly’s trial break is the second with Covid-19, which occurs in as many days. Just yesterday, Johnson & Johnson stopped his process an experimental vaccine against the novel coronavirus after an “unexplained disease” was discovered in one of his volunteers. Safety pauses are not uncommon in drug and vaccine studies, and do not necessarily lead to clinical trial failure. Without further details, it is unclear how concerned we should be about the future of these treatments.