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Tuesday, November 16, 2021

Molecular Partners' Covid-19 therapy proves inactiv

 Ensovibep has become the latest Covid-19 treatment candidate to crash out of the NIH-sponsored Activ-3 basket trial, wiping 34% off Molecular Partners’ share price. A planned futility analysis of the cohort evaluating ensovibep, a darpin Molecular Partners licensed to Novartis, concluded that enrolment should be stopped. Activ-3 is looking at potential therapies for hospitalised patients, but no agent in the trial has yet succeeded. The study's clinicaltrials.gov entry was also edited this month to state that Astrazeneca’s MAb combo AZD7442 was no longer being administered either, but no explanation has been offered for this. As a result, Pfizer’s IV antiviral PF-07304814 (lufotrelvir) is the only project still standing in Activ-3, at least until any new ones are added. There is some comfort for Molecular Partners in that Activ-3 backed ensovibep’s safety profile, which was consistent with the standard of care, Gilead’s Veklury, the company said. Ensovibep is in a separate phase 2/3 trial, Empathy, in Covid-19 outpatients, with interim data on the first 400 expected in early 2022. But in this niche Pfizer’s Paxlovid, an oral drug related to lufotrelvir, has set a standard that will be very hard to beat – as Molecular Partner’s shareholders clearly understand. 

Activ-3: NIH-funded phase 3 trial in hospitalised patients
CompanyProject DescriptionOutcome 
Lilly/AbcelleraBamlanivimabInfused MAb326 pt arm closed for futility Oct 2020
Vir BiotechnologySotrovimabIntramuscular or infused MAb344 pt arm closed for futility Mar 2021
Brii BiosciencesBRII-196 and BRII-198Infused MAb combination 343 pt arm closed for futility Mar 2021
Molecular Partners EnsovibepInfused antiviral470 pt arm closed for futility Nov 2021
AstrazenecaAZD7442 (tixagevimab + cilgavimab)Infused MAb combination Arm closed Nov 2021, reason unclear
PfizerLufotrelvirInfused antiviralArm ongoing
All patients received a backbone of Gilead's Veklury as standard of care. Source: clinicaltrials.gov.

https://www.evaluate.com/vantage/articles/news/snippets/molecular-partners-covid-19-therapy-proves-inactiv

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