Covid-19 roundup: Moderna, US sign contract for autumn booster doses; Enanta touts PhI results for its antiviral

29 Jul 2022
endpts.com
VaccineSmall molecular drugmRNA
The US government has placed a contract for 66 million doses of Moderna’s Covid-19 vaccineCovid-19 vaccine booster candidate, and the deal could balloon to another 234 million doses. The contract includes up to $1.74 billion for Moderna to manufacture and deliver the doses of the bivalent vaccine candidate, dubbed mRNA-1273.222. The shot contains antigens against the BA.4/BA.5 Omicron subvariant strains and is part of Moderna’s effort to deliver a booster shot this autumn, pending the necessary go-ahead from the FDA and CDC. Per shot, that’s $26.36. In August 2020, the US bought 100 million doses of the Moderna vaccine for about $10 less, at approximately $15.75 a pop, according to Reuters . Meanwhile, the European Union has in the past paid between $22.60 to $25.50 for each Moderna dose, according to the New York Times . “We look forward to receiving these new variant-specific vaccines and working with state and local healthcare partners to make the vaccines available for free in communities around the country this fall,” Health and Human Services Assistant Secretary Dawn O’Connell said in a statement. A Massachusetts biotech that mainly works on developing small molecule drugs for viral infections and liver diseases is also developing an oral antiviral for Covid-19 — and is now providing data. Enanta Pharmaceuticals announced topline data on Friday from its Phase I study assessing the safety and tolerability of a once-daily oral candidate, dubbed EDP-235, in healthy adults. The candidate is a 3CL protease inhibitor. According to the data from Enanta’s Phase I, the results showed the candidate had favorable safety, tolerability, and PK with strong exposure multiples over the EC90, which supports moving forward in a Phase II study in the fourth quarter of the year using only one dose. The company said the candidate is safe and well-tolerated in healthy subjects for up to 400 mg for up to seven days. The adverse events included headache and gastrointestinal-related symptoms during the investigation with multiple doses. There were three study discontinuations reported with one moderate headache in the 400 mg cohort, one severe headache with 800 mg and one grade 3 ALT/grade 2 AST elevation also in the 800 mg section. A total of 72 subjects were a part of the study. “Preclinical data show good distribution into other key target tissues, which may allow EDP-235 to inhibit the virus at possible sites of ongoing replication potentially linked to long Covid. Our data support a convenient dosing regimen, with strong exposure multiples for both the 200mg and 400mg doses, without the need for ritonavir boosting. We are targeting a one pill, a once-a-day antiviral treatment regimen that is active against all COVID-19 variants of concern,” said Enanta CEO Jay Luly.
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