Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced the suspension of MK-7110 development (formerly known as CD24Fc) designed for the treatment of hospitalised COVID-19 patients.
In December 2020 Merk obtained MK-7110, a first-in-class therapeutic candidate based on a recombinant fusion protein that targets the innate immune system, whilst acquiring OncoImmune, a privately owned clinical-stage biopharmaceutical company. Through a subsidiary, Merck acquired all outstanding shares of OncoImmune for an upfront payment of $425 million in cash.
FDA requires supplementary study evidence beyond the data submitted by Oncolummune
The reason for the MK-7110 development discontinuation is associated with the feedback obtained from the US Food and Drug Administration, that supplementary study evidence beyond the data submitted by Oncolummune, will be required to support a possible Emergency Use Authorization application. Furthermore, MK-7110 is not projected to be available until the first half of 2022, based on the additional testing that will be needed involving new clinical trials as well as research related to manufacturing at scale.
Merck to dedicate resources to more urgent needs during the pandemic
Given these regulatory, technical and clinical timelines Merck has decided to discontinue the development of MK-7110 for COVID-19 treatment and dedicate the resources for the development and manufacture of the most viable drugs and vaccines in order to meet more urgent needs during the pandemic, such as advancing molnupiravir and producing Johnson & Johnson’s COVID-19 vaccine.
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories stated:
“Merck’s commitment from the outset of the pandemic has been to deploy our expertise and capabilities where they can have the most impact. Merck is now focusing its efforts on advancing molnupiravir, which, as an oral medicine for outpatient use, represents a promising potential new approach, and on accelerating production of Johnson & Johnson’s COVID-19 vaccine.”
For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. The company has demonstrated commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships.
Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world.
For more information, visit www.merck.com