ALPHARETTA, Ga., April 2, 2020 /PRNewswire/ -- Ennaid Therapeutics, LLC, a specialty pharmaceutical company that uses its artificial intelligence (AI)-based drug discovery platforms to develop antiviral drugs, today announced that it is advancing the 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 U.S. Food and Drug Administration (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 successfully and broadly treat COVID-19 and other coronaviruses (CoVs).
Darnisha Harrison, Founder and CEO at Ennaid Therapeutics, said, "Our science strongly suggests that ENU200, a repurposed drug with a well-established clinical and safety profile, has the potential to be a broad solution to address the COVID-19 pandemic and, specifically, the near 80 percent of coronavirus cases that are asymptomatic, mild to moderate. 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. Additionally, unlike other COVID-19 drugs in development, which must be administered via injection or intravenously under the care of a physician, ENU200 can be administered orally, thus 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, 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 their iClickCare®️ secure clinical reporting software service to monitor the in-home trials. Ennaid is currently in discussions with the FDA and other regulatory agencies around the world regarding the planned clinical trial, which if approved, could enable ENU200 to be available to patients in six to nine months.
ENU200 is an orally delivered antiviral compound previously approved to treat other infections. 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 successfully and broadly treat COVID-19 and other coronaviruses. One of the biggest benefits of dual blockage of two proteins is that it will be much harder for the virus to mutate and become resistant.
ENU200 may be developed as a 505(b)(2) product or under the FDA's emergency/compassionate use regulatory pathway, can be shipped around the world, and, as an oral formulation, could potentially enable in-home treatment for COVID-19 infections using Ennaid's iClickCare® secure clinical reporting software service. Conversely, other COVID-19 therapies in development are largely single mechanism of action, IV-based therapeutics that require hospitalization and significant healthcare worker participation.
About Ennaid Therapeutics LLC
Ennaid is a specialty pharmaceutical company using state-of-the-art AI-based drug discovery platforms to develop antiviral drugs that treat diseases in the Flaviviridea and Coronaviridae family of viruses, specifically SARS-CoV-2 of the coronaviruses (CoVs). Since inception, Ennaid has focused on the treatment of mosquito-borne diseases including Zika virus and Dengue virus, which have caused pandemics. The pipeline includes Zika virus and has additional indications to treat and prevent the following viruses: dengue, West Nile, hepatitis c, yellow fever, tick-borne encephalitis, Japanese encephalitis, European encephalitis, and Kyasanur Forest virus. These programs were entering preclinical testing and have been placed on hold so that Ennaid can focus on developing a COVID-19 therapeutic. For more information visit: www.ennaidthera.com.
Ingrid Mezo (Media)
SOURCE Ennaid Therapeutics, LLC