The safety, tolerability and pharmacokinetic profile of molnupiravir have been described in a recently published article. An unprecedented collaboration between the sponsor, contract research organization (CRO) and regulatory authorities allowed an accelerated generation of this phase I data, including administration of the first-in-human (FIH) dose of molnupiravir within 5 days of acquiring approval from the Research Ethics Committee (REC) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK). 

Regular, direct communication with regulatory authorities and parallel, streamlined sponsor-CRO working groups promoted this accelerated timeline. Dosing in healthy volunteers was achieved for eight single ascending doses (SAD) cohorts, seven multiple ascending doses (MAD) cohorts, and one food-effect (FE) cohort within about 16 weeks of initial protocol submission to the REC and MHRA.

With standard industry timelines, the FIH study would have been completed in approximately 46 weeks and 33 weeks would have been needed to allow Phase 2 dosing. Submission of a Phase 2/3 clinical trial protocol to the US Food and Drug Administration (FDA) was done within 8 weeks of initial protocol submission, and FDA comments permitted phase 2 study initiation within 2 additional weeks. 

In global pandemic scenarios, this model of collaboration permits the accelerated generation of clinical data than standard processes, without compromising safety. 

Source: Preprint (version 1) research square, may 14th, 2021. Doi: https://doi.org/10.21203/rs.3.rs-477300/v1