In May, Merck announced a collaboration with Ridgeback Biopharmaceuticals LP (Ridgeback) to jointly develop EIDD-2801, an orally available antiviral candidate currently in early development for the treatment of patients with COVID-19. Influential sources have conveyed to the TrialSite that the intention will be to demonstrate superiority over Gilead’s Remdesivir as some scientists believe the product will evidence greater efficacy with the added benefit of oral availability. Remdesivir presently requires intravenous administration, and the rumblings are that forthcoming results from large global studies could disappoint. The early movers don’t always win in emerging markets, and the COVID-19 antiviral market is definitely an unfolding one. In the meantime, Gilead launched a study to test an inhalable version of the drug.
As TrialSite reported in March, Emory University chemists discovered the small-molecule antiviral and entered into a licensing deal with Ridgeback and an Emory University non-profit to develop the drug.
What is EIDD-2801?
EIDD-2801 works very similarly to Gilead’s Remdesivir. As it turns out, the molecules in both experimental drugs are nucleoside analogs that metabolize into a form that blocks polymerase, which is a vital element of viral replication, reports Chemical & Engineering News.
However, unlike Remdesivir, which can only be administered intravenously, EIDD-2801 can be taken in pill form, making the potential treatment far more accessible. According to Mark Denison, a coronavirus expert and scientist from Vanderbilt Medical School who partnered with Emory and the University of North Carolina researchers, the advantages of EIDD-2801 make it worth consideration.
EIDD-2801 also has the ability to essentially disrupt COVID-19 and its “proofreading” function. Additionally, it blocks RNA polymerase differently than that of Remdesivir, potentially making them complimentary.
But EIDD-2801 has no record of safety data. Hence, now the Phase 1 clinical trials.
Merck and Ridgeback Deal
Merck set up a subsidiary to license the investigational product and gained exclusive worldwide rights to develop and commercialize EIDD-2801 and related molecules. Merck agreed to pay Ridgeback, but the amounts were not disclosed. Moreover, a number of other payments including milestone payments plus a share of net proceeds of EIDD-2801 and related molecules if approved.
In April, Ridgeback initiated a Phase 1 clinical trial #NCT04392219 targeting 139 participants. The biotech entered into a deal with Covance (LabCorp) at research units led by Lawrence Galitz (Daytona Beach, FL site); Jeanelle Kam (Dallas, TX site); Irene Mirkin (Madison, WI site); and Jim Bush (Leeds, UK site). This study commenced in April 2020 and is estimated to run until August 2020.
Ridgeback commenced a Phase 2 study #NCT4405570 on June 16, targeting completion September 2020. This Phase 2a double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection in symptomatic adult outpatients with COVID-19. Study sites include the University of North Carolina School of Medicine (PI William Fischer) and Wake Forest Baptist Health (Caryn Morse).
Another single-center, randomized, double-blind, placebo-controlled study: #NCT04405739 assesses the efficacy and safety of EIDD-2801 on the SARS-CoV-2 virus shedding in newly hospitalized adults with PCR-confirmed COVID-19. Actual centers involved include Johns Hopkins Bayview Medical Center and Johns Hopkins; Suburban Hospital in Bethesda, MD; and Howard County General Hospital in Columbia, MD. Ashwin Balagopal serves as the Principal Investigator for all centers.
Affordability if Approved?
Merck and Ridgeback are committed to ensuring that any medicines we develop for SARS-CoV-2 will be accessible and affordable globally.
Meanwhile, Gilead understands the dangerous competition it faces; hence it’s in a race to produce a version that is not only economical but could be inhaled, with its recent announcement to kick off a clinical trial. As evidence reveals, the upper respiratory tract is the most prevalent site of SARS-CoV-2 infection early in the disease. The company will work night and day to introduce a nebulized, inhaled solution for non-hospitalized patients.
Remdesivir Inhalable Version Study
Earlier in July, Gilead commenced a Phase 1a randomized, placebo-controlled trial targeting approximately 60 healthy individuals aged 18-45 in the United States to form the basis for further clinical study of the inhaled drug.
Call to Action: The TrialSite monitors the unfolding situation with both EIDD-2801 and inhalable Remdesivir studies. For updates, sign up for the newsletter.