Taiwan FDA Approves SyneuRx’s IND Application for COVID-19 Clinical Trial

Press Release

Jun 08, 2021

Taipei, Taiwan, June 8, 2021 — SyneuRx International (Taiwan) Corp. (TWSE: 6575), announced today that an IND application for SNB011, using its lead compound Pentarlandir®, COVID-19 clinical trial has been approved by Taiwan FDA (TFDA).  Since SNB011 clinical study has been initiated in the US in April this year, this IND application was approved in a short 5-day review, according to TFDA’s Clinical Trial Notification fast track review. 
  SNB011 plans to enroll COVID-19 patients with mild symptoms within 48 hours of diagnosis confirmed by a positive PCR test. Pentarlandir® are oral capsules, which allows patients to administer the medication at the convenience of their homes, avoiding the need of hospitalization or quarantine. If developed successfully, Pentarlandir® is to COVID-19 will be what Tamiflu is to flu. Such treatment is likely to  fill the void arising from unequal distribution of vaccines, low vaccination rates, and inconsistent vaccine efficacies, and to lessen the disease burdens on patients, their family, and friends, and on the health care system as a whole. 
  SyneuRx’s Chairman and CEO, Emil Tsai, MD, PhD, MAS, pointed out that ”Both Pentarlandir® and Pfizer’s PF-07321332 are designed as oral capsules, have  the same mechanism of action working against the Main protease of SARS-CoV-2, and carry the potential in inhibiting  SARS-CoV-2 variants. To date, SyneuRx and Pfizer are the only two companies whose experimental Mpro inhibitors are in human testing.  I hope both drugs can be successfully launched, to resolve the predicament of lacking COVID-19 drug  treatment.” 
  Pentarlandir® has a long history in human use,  which has demonstrated a high level of safety. SyneuRx’s preclinical work has shown that Pentarlandir® can work against SARS-CoV-2 in 3 mechanisms of action : (1) inhibiting the main protease of SARS-CoV-2 to suppress virus replication, (2) inhibiting the transmembrane protease serine 2 (TMPRSS2) of human cells to block virus entry to human cells, and (3) providing anti-inflammatory effect against cytokine storm that can lead to the deterioration of the illness. Thus, Pentarlandir® can be applicable to a wide majority of COVID-19  patients who typically have mild symptoms. 
  In addition, Pentarlandir® is an efficacious D-amino acid oxidase (DAAO) inhibitor which modulates NMDA receptors and protects neurons in human brain. Therefore, Pentarlandir® can also treat the common post-COVID-19 conditions such as depression, anxiety, and memory deterioration, killing two birds with one stone. 
  “Unequal distribution of COVID-19 vaccines is the main reason of the sustained spread of pandemic worldwide. Apparently, Taiwan is suffering geopolitical impacts caused by such unequal distribution. SyneuRx will do its best to help resolve the global pandemic,”  added Dr. Emil Tsai. 
About COVID-19 and its available therapies 
  To date, more than 170 million people across the globe are infected by SARS-CoV-2 and more than 3.7 million have died. Remdesivir has been approved by US FDA for hospitalized patients. In addition, two monoclonal antibody-based cocktail therapies bamlanivimab plus etesevimab and casirivimab plus imdevimab have also been issued EUA for patients with mild symptoms. However, WHO does not recommend the use of remdesivir, and the use of monoclonal antibodies is inconvenient as the antibodies need to be injected intravenously.  
About SyneuRx International (Taiwan) Corp.  
  SyneuRx is a global biotech company listed in 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, including schizophrenia, dementia, depression and COVID-19. 
Forward-Looking Statements 
  This press release does not constitute any invitation or offer to purchase or subscribe for the stocks of SyneuRx. The forward-looking statements in the press release are neither promises nor guarantees of future performance, and are subject to various risks and uncertainties, which may cause huge deviation from the expected results in those forward-looking statements. SyneuRx has no obligation to amend or update this press release to respond to any events that occur after the publication of this article. New drug development takes a long time and high investment costs, without guarantee of success. All these unpredictabilities may put the investment at risk. SyneuRx does not encourage short-term investment. Investors should make diligent judgments and invest carefully.