Adagio presses forward with their FDA pitch for Covid antibody — despite Omicron flaws
Adagio, the Tillman Gerngross biotech whose $750 million plan to build a pan-coronavirus antibody seemingly fell apart in the face of Omicron, is back again pleading its case.
The company released data from its pivotal trials Wednesday, announcing that its antibody adintrevimab reduced the risk of hospitalization or death in participants with mild to moderate Covid-19 by 66%, including a 77% reduction in patients who were treated within 3 days of symptom onset.
The drug also worked as pre-exposure and post-exposure prophylaxis, reducing the risk of volunteers developing symptomatic Covid-19 by 71% and 75% respectively.
The problem is that nearly all of the data for the study were collected prior to the advent of Omicron, a variant that Adagio’s own data showed reduced the potency of their antibody 300 times, forcing the company to pursue alternative strategies such as changing dose and combination treatments.
Despite the setbacks, the biotech continued to insist that the antibody was already so potent that it might have efficacy against Omicron, even if it was reduced. Limited data collected in the trials attested to that. For example, patients who received prophylactic adintrevimab were still 47% less likely to develop symptomatic disease within 77 days following the emergence of Omicron. (Adagio did not specify when they began the analysis or how widespread Omicron was at the time.)
But the US is no longer dealing solely with Omicron. Omicron’s “sister variant,” BA.2, is now causing a majority of new cases nationwide, according to CDC data.
And Adagio’s drug has virtually zero activity against BA.2, analyses from outside labs have demonstrated.
Nevertheless, the company is going to press its case at the FDA, with plans to submit an application for emergency use authorization in Q2. The company’s statement did not address the drug’s dramatically reduced efficacy against BA.2.
Adagio also said it’s continuing with trials on a higher dose of adintrevimab while developing new antibodies from its library and attempting to re-engineer adintrevimab to have improved binding against the new variants.