Merck: Merck and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for Molnupiravir, an Investigational Oral Therapeutic for the Treatment of Mild-to-Moderate COVID-19

Merck and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for Molnupiravir, an Investigational Oral Therapeutic for the Treatment of Mild-to-Moderate COVID-19

Merck, News Release (Preprint), NCT04575584 (history)

Merck, Merck and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for.., , News Release (Preprint), NCT04575584

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News release reporting that the trial of molnupiravir with hospitalized patients (NCT04575584 (history)) has been discontinued because data indicates it is unlikely to demonstrate a clinical benefit in hospitalized patients. Results are not available yet. Interim results for the trial with outpatients show positive dose-dependent results for viral clearance.

Concerns have been raised that the mutagenic mechanism of action may create dangerous variants or cause cancer [Hadj Hassine, Swanstrom]. See [Fountain-Jones, Sanderson, twitter.com] for analysis of variants potentially created by molnupiravir.

1. Fountain-Jones et al., medRxiv, doi:10.1101/2022.12.21.22283811, Antiviral treatments lead to the rapid accrual of hundreds of SARS-CoV-2 mutations in immunocompromised patients, https://www.medrxiv.org/content/10.1101/2022.12.21.22283811.

2. Hadj Hassine et al., Viruses, doi:10.3390/v14040841, Lethal Mutagenesis of RNA Viruses and Approved Drugs with Antiviral Mutagenic Activity, https://www.mdpi.com/1999-4915/14/4/841.

3. Sanderson et al., medRxiv, doi:10.1101/2023.01.26.23284998, Identification of a molnupiravir-associated mutational signature in SARS-CoV-2 sequencing databases, https://www.medrxiv.org/content/10.1101/2023.01.26.23284998.

4. Swanstrom et al., Science, doi:10.1126/science.abn0048, Lethal mutagenesis as an antiviral strategy, https://www.science.org/doi/10.1126/science.abn0048.

5. twitter.com, https://twitter.com/LongDesertTrain/status/1597353291868155906.

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Merck et al., 15 Apr 2021, preprint, 1 author, trial NCT04575584 (history).

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