Emergent BioSolutions (NYSE:EBS) announces the initiation of an NIAID-sponsored Phase 3 clinical trial, INSIGHT-013, evaluating COVID-HIG (one of four such products), a hyperimmune immunoglobulin derived from plasma of people who have recovered from COVID-19, in hospitalized patients infected with the coronavirus.
The 500-subject study will compare the plasma-derived therapies plus standard-of-care (SOC) treatment compared to placebo + SOC. All participants with receive background therapy of Gilead Sciences’ (NASDAQ:GILD) Veklury (remdesivir).
The primary endpoint is a comparison of clinical status in each group at day 7 of follow-up.
Secondary endpoints include all-cause mortality at day 28, discharge status at three time points (day 7, 14, 28) and time to recovery at same three time points.
The estimated completion date is July 2021.
Following up on their announcement on September 14, Eli Lilly (LLY +1.9%) and licensor Incyte (INCY +1.3%) announce additional data from an NIAID-sponsored study, ACTT-2, evaluating the combination of Olumiant (baricitinib) and Gilead Sciences’ (GILD +0.5%) Veklury (remdesivir) compared to remdesivir alone in hospitalized COVID-19 patients.
As previously reported, the trial met the primary endpoint of reducing time to recovery, one day, compared to remdesivir alone. The most significant benefits were observed in patients requiring supplemental oxygen and those needing high-flow oxygen/non-invasive ventilation.
New data showed that the odds of improvement in clinical status at day 15 were 30% greater in the baricitinib arm. There was a lower mortality rate (5.1% vs. 7.8%) in the baricitinib group but the separation was not statistically significant.
Lilly is continuing talks with the FDA regarding a potential emergency use authorization (EUA) application.
The FDA OK’d Olumiant in June 2018 for rheumatoid arthritis.
Intercept Pharmaceuticals (ICPT -5.1%) is down on 60% higher volume in reaction to a report that the FDA is investigating a potential safety signal related to Ocaliva (obeticholic acid), specifically, the risk of liver injury. The inquiry began in May and could take a year to complete.
The agency granted accelerated approval of the farnesoid X receptor agonist in May 2016 for primary biliary cholangitis which slowly destroys the bile ducts. Two Phase 3 studies in NASH patients are ongoing.
Quant rating is Neutral.
Aimed at assuaging concerns from governments and investors, Moderna (NASDAQ:MRNA) states that it will not enforce its patents covering COVID-19 vaccine mRNA-1273 while the pandemic persists and is willing to license the patents to others afterward.
President Stephen Hoge says, “We’re quite studiously not asserting infringement. We’re doing the opposite of creating that kind of anxiety for folks. We’re not interested in using that IP to decrease the number of vaccines available in a pandemic.”
Shares up 1% premarket on light volume.
Regeneron (NASDAQ:REGN) is going to get emergency approval, says the president this morning, after last night praising the company’s coronavirus antibody treatment as making him feel better immediately. “I call that a cure.”
The company filed for emergency use authorization last night.
He also says Eli Lilly (NYSE:LLY) is going to get approval for its Covid-19 antibody. Trump also says he’s spoken with Lilly’s CEO. The company yesterday filed for EUA for that treatment.
LLY +2%, REGN +4.8% premarket
