Molnupiravir is a direct-acting oral, broad-spectrum antiviral agent in clinical development as a treatment for COVID-19. Ridgeback has completed Phase 1 and Phase 2 studies. The program has advanced into Phase 3 development as a therapeutic for COVID-19. Administered as an oral capsule, Molnupiravir has also shown activity in animal models of Ebola, Equine Encephalitis (VEEV and EEEV), Influenza (seasonal, pandemic and avian), and Respiratory Syncytial Virus.
Molnupiravir is being developed under a collaboration agreement with Merck (known as MSD outside the U.S. and Canada).
- Media / Wall Street Journal 11.04.2021
- Press Release / Business Wire 11.04.2021
* Partnered with Merck
Ridgeback would like to acknowledge and thank our collaborators on the molnupiravir (EIDD-2801) development program:
Dr. George Painter’s lab at DRIVE (Drug Innovation Ventures at Emory) starts screening targets for active pharmaceutical agents against pandemic threats.
Dr. George Painter, CEO of DRIVE, and Wendy Holman, CEO of Ridgeback Biotherapeutics, meet to discuss Ridgeback licensing molnupiravir from DRIVE.
DRIVE files an Investigational New Drug (IND) application with the FDA to study molnupiravir in seasonal flu.
Ridgeback and DRIVE sign definitive agreement for a license and collaboration to develop molnupiravir.
Ridgeback in collaboration with DRIVE commences planning and implementation of large-scale manufacturing of molnupiravir, onboards staff of external experts and DRIVE consultants and plans a phase 1 clinical trial to support an expedited path to COVID-19 development.
Ridgeback files Investigational New Drug (IND) application with the FDA to study molnupiravir in COVID-19. Ridgeback files application with UK’s MHRA to study molnupiravir in COVID-19.
Ridgeback begins Phase 1 clinical trials – single ascending dose, multiple ascending dose and fed/fasted studies of molnupiravir.
Ridgeback begins manufacturing run of molnupiravir.
Ridgeback initiates Phase II trial evaluating molnupiravir in patients with COVID-19 in the outpatient setting (2003 study).
Ridgeback initiates second and third manufacturing run of molnupiravir.
Ridgeback and Merck finalize partnership agreement for molnupiravir.
Ridgeback initiates Phase II trial evaluating molnupiravir in patients with COVID-19 in the inpatient setting (2004 study).
Ridgeback and the AGILE Clinical Trials Platform announce initiation of the AGILE study which evaluates the treatment effect of molnupiravir in patients with COVID-19 in the outpatient setting in the United Kingdom.
Merck and Ridgeback Biotherapeutics announce initiation of Pivotal Phase 2/3 MOVe-OUT and MOVe-IN studies evaluating molnupiravir in patients with COVID-19 both in the hospital and out of the hospital setting.
Merck and Ridgeback Biotherapeutics announce initiation of pivotal phase 3 MOVe-AHEAD study evaluating molnupiravir for post-exposure prophylaxis of COVID-19 infection.
Merck and Ridgeback Biotherapeutics announce molnupiravir significantly reduced the risk of hospitalization or death in an interim analysis of the Phase 3 MOVe-OUT trial, and that recruitment into the study is being stopped early due to these positive results, at the recommendation of an independent Data Monitoring Committee and in consultation with the FDA.