SyneuRx Initiates Clinical Trial SNB01 Pentarlandir® For Covid-19

Press Release

Apr 27, 2021

  Taipei, Taiwan, April 27, 2021 — SyneuRx International (Taiwan) Corp. (TWSE:6575), announced today that a kick-off meeting was conducted with its collaborator Prevail InfoWorks to initiate its SNB01 clinical trial in the US. The IND was granted by the US FDA in February, 2021, to investigate the safety and efficacy of its investigational antiviral drug Pentarlandir® for the treatment of early COVID-19 patients in the US.

  SNB01 plans to enroll about 90 subjects with mild symptoms of COVID-19 from up to 15 centers in the US. The subjects will be randomized 1:1:1 into high dose, low dose and placebo groups to receive 2 weeks of Pentarlandir® treatment or placebo, and be followed up for 6 weeks. The enrollment is expected by late June or early July. An interim analysis will be conducted for safety evaluation upon the completion of about half of the planned subjects. The results of SNB01 will inform the optimal dose for the subsequent phase 3 study.

  Pentarlandir® is a promising potent antiviral drug against COVID-19 and potentially other coronaviruses as well. SyneuRx has shown in preclinical work that Pentarlandir® can work against SARS-co-V-2 by 3 mechanisms of action (MOA): (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. To our knowledge, Pentarlandir® is the only investigational antiviral drug that has triple inhibition mechanisms. Pentarlandir® is designed as an oral capsule for the convenience of administration. In addition, SyneuRx also discovered that Pentarlandir® demonstrates strong inhibition against OC43 viral replication, the virus responsible for the 1889 Russian flu that cost more than one million lives. We believe that Pentarlandir® has the potential to address threats from the families of coronavirus in the future.

        Facing such a global catastrophic pandemic, SyneuRx views that the problems of existing COVID-19 vaccines, such as inconsistent efficacy, inadequate mass production, and unequal distribution, prompt the need of developing antiviral drugs concurrently. Recent outbreaks across South America, India and Europe also accentuate the importance of efficacious and convenient antiviral treatment. Even in the US where vaccines are abundant, vaccination rate is estimated to be 70% at most.  The fact that Pfizer is still eagerly developing antiviral treatment after its successful launch of the mRNA vaccine points to the same vision. SyneuRx and Pfizer are the only two companies whose experimental Mpro inhibitors are already in human testing (Pentarlandir® and PF-07321332 and PF-07304814, respectively). SyneuRx’s SNB01 is now in phase 2, while Pfizer’s both agents are in phase 1 trials. Because Mpro is known to be a highly conserved region across coronavirus variants, Dr. Mikael Dolsten, the Chief Scientific Officer of Pfizer, considers that their investigational agents could be inhibitors of the entire coronavirus family.

About COVID-19 and its available therapies
  To date, more than 150 million people across the globe are infected by SARS-CoV-2 and more than 3 millions 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.