Type: Repurposed, patent-pending, oral antiviral drug previously approved by FDA
Status: On May 13, Catalent said it will develop a powder-in-capsule formulation of Ennaid’s ENU200 through a collaboration whose value was not disclosed. Catalent’s San Diego development site will manufacture roller-compacted formulations of ENU200 within capsules for further study. “We are able to rapidly deliver Ennaid’s demand for drug product in a matter of weeks,” stated Jonathan Arnold, President, Oral and Specialty Delivery at Catalent.
In April, Ennaid said it is advancing development of ENU200 to treat the up to 80% of asymptomatic, mild to moderate cases of COVID-19 viral infections. Ennaid said in-silico modeling conducted by the company has shown that ENU200 delivers specific antiviral activity against two SARS-CoV-2 proteins, S glycoprotein and Mpro. Ennaid reasons that the simultaneous blockage may result in enhanced antiviral activity that could successfully and broadly treat COVID-19 and other coronaviruses.
Ennaid said it is in talks with the FDA and other regulatory agencies worldwide on its planned Phase III in-home, self-dosing clinical trial, which would assess ENU200 in patients with asymptomatic, mild to moderate coronavirus infections. The trials would be monitored through the iClickCare® secure clinical reporting software service. “We anticipate the clinical trials could start within 90 days,” Ennaid founder and CEO Darnisha Harrison told Baton Rouge, LA, TV station WBRZ.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: