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eFFECTOR Therapeutics, Inc., a leader in the development of selective translation regulation inhibitors (STRIs) for the treatment of cancer, today announced that the first patient has been dosed in a Phase 1b trial evaluating zotatifin (eFT226) as an antiviral agent in an outpatient setting for those with mild to moderate COVID-19 disease. This study is sponsored by a $5.0 million cooperative agreement from the Defense Advanced Research Projects Agency (DARPA) and Defense Health Agency (DHA) and is being conducted in collaboration with the Quantitative Biosciences Institute (QBI) at University of California, San Francisco (UCSF).
"Rising cases of COVID-19 due to emerging variants and lack of vaccination in far too many people highlight the need for more effective therapies," said Steve Worland, Ph.D., president and CEO of eFFECTOR. "We believe that positive clinical data from this trial would support continued development of zotatifin as an antiviral treatment for SARS-CoV-2 and its emerging variants, such as the Delta variant, as well as potential future coronavirus strains that may emerge for which vaccines will be unavailable. Furthermore, by targeting a human protein required for viral replication, known as a host protein, zotatifin is expected to be less susceptible to resistance arising from viral mutations than approaches directed against virus-encoded proteins, such as nucleosides or protease inhibitors."
The Phase 1b trial is a double-blind, randomized dose escalation trial in non-hospitalized patients ages 18-65 with mild to moderate COVID-19. Primary endpoints of the study include safety and tolerability of zotatifin in patients with COVID-19. Secondary endpoints include antiviral activity as assessed by mean change in viral load over time and time to viral load undetectability, as well as time to clinical resolution. Zotatifin will initially be administered in two intravenous (IV) infusions one week apart. eFFECTOR recently concluded toxicology and pharmacokinetic studies demonstrating comparable exposure and safety between IV and subcutaneous administration of zotatifin and anticipates transitioning to subcutaneous administration, which is more conducive to treatment in an outpatient setting.
An independent international study published in Nature and led by Nevan Krogan, Ph.D., professor, Department of Cellular and Molecular Pharmacology and director of the Quantitative Bioscience Institute at UCSF, identified zotatifin's antiviral activity against SARS-CoV-2 in in vitro studies. Subsequent in vitro studies confirmed that zotatifin had selective antiviral activity with approximately 10-fold greater potency than Remdesivir, the current standard of care for treating patients with COVID-19 with an antiviral agent, and more than 100-fold greater potency than AT-511, the free base form of AT-527, an agent currently in Phase 3 development as a direct-acting SARS-CoV-2 antiviral treatment. Further, in vitro studies have shown that zotatifin has potent antiviral activity across all unique coronavirus subtypes tested, including SARS-CoV-2, SARS-CoV-1, MERS-CoV and CoV-229E.
Posted In: LWAC
