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Hetero Announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India

Hetero, Press Release
Jul 2021  
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Hospitalization 70% Improvement Relative Risk Recovery time 33% Molnupiravir  Hetero et al.  EARLY TREATMENT  RCT Is early treatment with molnupiravir beneficial for COVID-19? RCT 741 patients in India Lower hospitalization (p=0.0027) and faster recovery (p=0.0001) c19early.org Hetero, Press Release, July 2021 Favorsmolnupiravir Favorscontrol 0 0.5 1 1.5 2+
Interim results for CTRI/2021/05/033739, showing lower mortality and faster recovery.
Potential risks of molnupiravir include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity1-10. Multiple analyses have identified variants potentially created by molnupiravir11-15.
risk of hospitalization, 69.6% lower, RR 0.30, p = 0.003, treatment 7 of 371 (1.9%), control 23 of 370 (6.2%), NNT 23.
recovery time, 33.3% lower, relative time 0.67, p < 0.001, treatment 371, control 370.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Hetero et al., 9 Jul 2021, Randomized Controlled Trial, India, peer-reviewed, 1 author.
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Hetero Announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India
~ Phase 3 Trial Demonstrates Statistically Significant fewer hospital admissions, Faster Time to Clinical Improvement and early negative SARS CoV-2 RT PCR with Molnupiravir Treatment in Mild COVID 19 Patients Compared to Standard of Care alone~ ~ Hetero has approached the Drug Controller General of India (DCGI) to seek Emergency Use Authorization for Molnupiravir in India ~ India, Hyderabad, 9 th July 2021: Hetero, a globally renowned vertically integrated pharmaceutical organization, today announced the interim clinical results from Phase III Clinical trials of Molnupiravir in mild Covid-19 patients conducted across multiple COVID-19 dedicated hospital sites across India. In April this year, Hetero had entered into a non-exclusive licensing agreement with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK), to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries (LMICs). Molnupiravir is an investigational, orally administered form of a potent ribonucleoside analog, being developed globally by MSD, that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19 with demonstrated activity against SARS-CoV-2 in human airway epithelial cell cultures and potential to completely eliminate SARS CoV-2 from the body within 5 days. Hetero had commenced a phase-III, comparative, randomized, multicenter clinical trial on mild Covid-19 patients (N=1218). These clinical trials were aimed at evaluating the efficacy and safety of Molnupiravir plus standard of care (test arm) versus standard of care alone (control
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