US FDA Approves SyneuRx’s IND Application for a First-in-Human, Proof of Principle Clinical Trial for Patients with Early and Mild COVID-19
SyneuRx announced today that US FDA has approved its Pentarlandir®, an orally-bioavailable small-molecule drug candidate as a treatment for early and mild COVID-19, to be evaluated in a proof-of-principle clinical trial conducted in the US.
Pentarlandir®, also known as SNB011, currently is the only anti-COVID-19 drug that inhibits dual protein targets, main protease of SARS-CoV-2 and transmembrane protease serine 2 (TMPRSS2) of human cells. Main protease of SARS-CoV-2 is known to be vital in viral replication, while TMPRSS2 is a cell-surface protein critical for viral entry into human cells. Accordingly, SyneuRx expects that Pentarlandir® is able to effectively prevent viral replication and entry into human cells. Pentarlandir® also has anti-inflammatory effects against cytokine storm that can lead to the deterioration of the illness. For convenient administration, Pentarlandir® is designed as capsule form.
SyneuRx’s Chairman and CEO, Emil Tsai, MD, PhD, MAS, notes that ‘human life has been constantly affected by various coronaviruses such as OC43, SARS-CoV, MERS and more recently SARS-CoV-2. It is important to develop a pan-corona antiviral drug.’ The SyneuRx R&D team has discovered that Pentarlandir® also demonstrates a strong inhibitory activity against OC43 viral replication, of which virus caused Russian flu during 1889-1895 with more than one million deaths.
Dr. Tsai added, ‘the development of COVID-19 vaccines and drugs in paralell are absolutely necessary under the catastrophic global pandemic’, and ‘the development of anti-COVID-19 drugs can lessen the impact of geopolitics caused by inequality in vaccine distribution.
Current status of COVID-19 and its available therapies
To date, more than 110 million people across the globe are infected by SARS-CoV-2. Remdesivir has been approved by US FDA for hospitalized patients. In addition, two monoclonal antibody-based therapies bamlanivimab and a cocktail of casirivimab and imdevimab have also been issued EUA for patients with mild symptoms. However, WHO does not recommend to use remdesivir, and the use of monoclonal antibodies is inconvenient for patients as they need to be intravenously injected.
About SyneuRx International (Taiwan) Corp.
SyneuRx is a global biotech company listed at Taiwan (TWSE: 6575), undergoing clinical development of new classes of drugs for multiple major CNS disease conditions and COVID-19. Several early and late phase clinical trials are currently in progress for multiple indications globally.
Forward Looking Statements
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