Five months after making an upfront payment of $425 million in cash to acquire OncImmune and its phase 3 COVID-19 therapeutic, CD24Fc, Merck announced it is discontinuing the development of the candidate, now referred to as MK-7110.
In September of 2020, prior to the acquisition, OncoImmune released topline results from a pre-planned interim efficacy analysis of the phase 3 SAC-COVID trial. Data from 203 patients (75% of the planned enrollment) show that severe or critical COVID-19 patients treated with CD24Fc exhibited significantly faster recovery and significantly reduced disease progression to death or respiratory failure than those receiving placebo, when used in conjunction with the standard of care (SOC).
In a 10-k report filed with the U.S. Securities and Exchange Commission in February of 2021, the FDA indicated additional data beyond the Phase III study conducted by OncoImmune would be required prior to an Emergency Use Authorization approval. Merck stated that the additional research required to obtain EUA – including new clinical trials as well as research related to manufacturing at scale – MK-7110 would not be expected to become available until the first half of 2022. This timeline, along with technical, clinical and regulatory uncertainties and the availability of several medicines for patients hospitalized with COVID-19, led Merck towards the decision to discontinue development of MK-7110 for COVID-19. The company will focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine.
Merck terminated its internal COVID-19 vaccine programs in January in order to focus on the development of therapeutics for the pandemic. Phase I data showed immune responses were inferior to what was observed in people who recovered naturally from COVID-19 infections.
Molnupiravir (EIDD-2801/MK-4482) is an orally administered form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2. Molnupiravir is being developed in collaboration with Ridgeback Therapeutics. The companies recently reported data from two trial, the phase 3 MOVe-OUT trial in Outpatients and the phase 2/3 MOVe-IN trial in hospitalized patients. Molnupiravir was not clinically beneficial in hospitalized patients, and hence the development of molnupiravir will proceed in non-hospitalized patients only.