Covid-19 roundup: Alexion's C5 inhibitor Ultomiris misses the PhIII bar; Lonza in waiting game to use ingredients in Moderna vaccine
C5 inhibition isn’t the answer to the search for treatments for severe Covid-19 after all.
Alexion is pausing enrollment to a Phase III study testing Ultomiris, the long-acting follow-on to Soliris, among patients requiring mechanical ventilation after the independent data monitoring committee raised a lack of efficacy in an interim analysis. Among 122 patients (out of a planned enrollment of 270), there was no meaningful difference in survival at Day 29.
The biotech stopped short of shelving the program right away, saying instead it will conduct further analysis to determine next steps — with an eye to identifying any subgroups that might benefit.
Approved for rare blood disorders, Ultomiris is one of the key growing franchise drugs featured in AstraZeneca’s surprise $39 billion buyout of Alexion. Like the cash cow Soliris, it works by blocking the complement C5, and the initial hypothesis was that the drug could lower cytokine and chemokine levels, thereby reducing lung inflammation.
“While initial anecdotal reports from compassionate use cases were promising, these results demonstrate the importance of conducting controlled clinical trials to fully evaluate the potential of new treatment approaches and generate the necessary evidence to make informed decisions,” John Orloff, Alexion’s head of R&D, said in a statement.
More data are coming, the company noted. A team of researchers at Cambridge University Hospitals NHS Foundation Trust is leading a platform study to investigate the potential of giving immune modulators earlier — before hospitalized patients need mechanical ventilation — to prevent progression of the virus.
Repurposing commercial drugs to treat Covid-19, especially at the severe stage, has proven an arduous, winding journey for many big players. Roche and Regeneron/Sanofi’s bet on the IL-6 class largely came up empty (although new data suggest there might yet be legs to the early hope), and Novartis didn’t have better luck with Jakafi, its Incyte-partnered JAK inhibitor.
Eli Lilly, though, did manage to secure an emergency use authorization for its own JAK drug Olumiant — in combination to Gilead’s approved antiviral, remdesivir. Meanwhile, Operation Warp Speed is promising up to $354 million to mass manufacture an experimental drug Merck obtained via the acquisition of OncoImmune, which was shown to reduce the risk of respiratory failure or death by 50% in a trial of 203 severe and critical patients.—Amber Tong
Lonza awaiting Swiss license at plant manufacturing active ingredients in Moderna’s vaccine
Lonza, the Basel-headquartered manufacturing giant, is currently in waiting mode at a new plant in Visp, Switzerland, where it’s started manufacturing active ingredients in Moderna’s Covid-19 vaccine — they just can’t be used yet.
Reuters reported Thursday that the manufacturer is still awaiting a necessary license from the country’s drug regulator Swissmedic, but that the first batch was expected to be ready this month. Lonza can produce and ship the drug ingredients before the facility is granted a license; they just can’t be released before that approval comes.
After completion of the initial production line, Lonza is preparing for two more Visp facilities to be commissioned, Reuters reported. The lines cost roughly $79 million, require between 60 and 70 employees to operate, and can each produce enough ingredients for 300 million annual doses of the mRNA vaccine.
Once produced, Reuters said Lonza would ship the ingredients to Laboratorios Farmaceuticos ROVI in Madrid for final filling.
It’s unclear when exactly Lonza could gain the Swissmedic license to use the ingredients, but a spokesperson told Reuters they expected a visit from state inspectors soon. — Conner Mitchell
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