Resverlogix Corp. ("Resverlogix") and EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, today announced a partnership to support planned commercialization of apabetalone in the United States, Canada (where authorization has been granted to conduct clinical studies of apabetalone for COVID-19) and/or potentially expanding to additional global markets, as Emergency Use Authorization and/or a New Drug Application or equivalent is issued or approved.
In preparation for launch, Resverlogix will utilize EVERSANA’s fully integrated commercialization services that include market access, agency services, clinical and commercial field teams, medical science liaisons, channel management, patient services, health economics and outcomes research, and compliance, with each service optimized by data and predictive analytics.
Apabetalone is an investigational, phase 3 clinical candidate with safety data in more than 4,200 man years of treatment. As previously published, apabetalone has the potential to combat COVID-19 through a unique dual mechanism. First, apabetalone treatment prevents SARS-CoV-2 from infecting human cells; and second, it reduces the inflammation and cytokine storm response, which can result in organ damage and long-term negative impacts. Apabetalone is also being studied for important benefits for patients with high-risk cardiovascular disease, chronic kidney disease and other indications while maintaining a well-described safety profile.
“With EVERSANA’s integrated commercialization solution, we are poised to swiftly and efficiently deliver apabetalone to patients who desperately need it,” said Donald McCaffrey, President and CEO of Resverlogix. “We are proud to be on the front line with the global scientific medical community as we fight the ongoing threat of this and future pandemics.”
“We believe in apabetalone’s potential to save the lives of patients still facing the tragic impact of COVID-19 and its numerous growing variants as well as the millions of patients facing multiple diseases that have the potential to be treated by this much-needed therapy,” said Jim Lang, Chief Executive Officer of EVERSANA. “Our COMPLETE end-to-end commercialization engine is mobilized and ready to move swiftly in anticipation of authorizations and approvals.”
There can be no assurance that regulatory approval will be obtained.
Resverlogix is developing apabetalone (RVX-208), a first-in-class small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. Apabetalone is the first therapy of its kind to have been granted U.S. FDA Breakthrough Therapy Designation – for a major cardiovascular indication – to help facilitate a time-efficient drug development program, including planned clinical trials and plans for expediting the manufacturing development strategy.
BET inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with high-risk cardiovascular disease, chronic kidney disease, COVID-19 and other indications while maintaining a well-described safety profile.
EVERSANA is the leading provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life science solutions for a healthier world. For more information,visit eversana.com.