Closely held Ennaid Therapeutics is advancing development of ENU200 as a therapeutic to treat the up to 80% of asymptomatic, mild-to-moderate cases of COVID-19 viral infections.
ENU200 is a repurposed, patent-pending, orally deliverable antiviral drug that was previously approved by the FDA for a different indication. In-silico modeling conducted by Ennaid has revealed that ENU200 delivers specific antiviral activity against two SARS-CoV-2 proteins: S glycoprotein and Mpro.
Ennaid’s science suggests that this simultaneous blockage may result in enhanced antiviral activity that could treat COVID-19 and other coronaviruses.
“Key to ENU200 is its target of two proteins on the SARS-CoV-2 virus that interfere with the virus’ ability to enter healthy cells and its replication,” Darnisha Harrison, founder and CEO, said in a statement, adding that ENU200 has the potential to be administered orally, enabling in-home treatment for COVID-19 infections.
Utilizing the FDA’s emergency/compassionate use regulatory pathway, or the FDA’s 505(b)(2) application process, Mr. Harrison said Ennaid believes it can quickly bring ENU200 to market by treating patients with COVID-19 in a Phase 3 in-home, self-dosing clinical trial of patients with asymptomatic, mild-to-moderate coronavirus infections, utilizing its iClickCare secure clinical reporting software service to monitor the in-home trials. If successful, he said ENU200 to be available to patients in six-to-nine months.