SyneuRx Announces Pentarlandir, Oral COVID-19 Twin Antiviral Drug Candidate, Has Entered Final Part of FDA Phase II Testing

NEW TAIPEI CITY, Taiwan and TORRANCE, Calif., November 19, 2021 / PRNewswire / – SyneuRx ™ International, (Taipei Exchange, ticker ID TT6575, www.syneurx.com), a pioneering developer of new CNS (Central Nervous System) and antiviral pharmaceuticals, today announced that its SARS- Experimental oral CoV -2 (COVID-19) antiviral drug candidate Pentarlandir® has been in a Phase II US-FDA trial for several months and is approaching Phase III in 2022.

Designed as an early stage COVID-19 treatment, Pentarlandir is administered orally to patients with either breakthroughcases of COVID-19 (for those who have been previously vaccinated or infected) or potentially as a first-line treatment route for unvaccinated people who might otherwise face potential hospitalization and death. SyneuRx has already received Revolutionary therapy designation and orphan drug designationFDA grants for its CNS drug candidates.

Pentarlandir is based on highly purified isomers of tannic acid and is derived from a botanical origin (much like Tamiflu®, which is itself purified from a chemical found in star anise). Pentarlandir specifically targets the main protease, or 3CL protease, which transforms the basic viral protein into the necessary building blocks for the replication of new viral particles and also inhibits TMPRSS2 for viral entry. Pentarlandir acts not only on the serine protease TMPRSS2, but also on HAT (both of which are essential for influenza-like viruses to enter cells). Therefore, it shows promise as a therapeutic tool for twinscenarios (treatment of endemic COVID-19 and influenza).

If successfully developed, SyneuRx intends to make Pentarlandir available to the worlds developing countries under the Medicines Patent Pool supported by the United Nations. Pentarlandir is expected to be widely available worldwide within 12-24 months of phase III depending on current factory availability.

More information on the Phase II Pentarlandir trial can be found here: www.clinicaltrials.gov/ct2/show/NCT04911777?term=syneurx&draw=2&rank=3

How was Pentarlandir discovered?

After years of research into how several debilitating CNS diseases work, scientists at SyneuRx came to the theory that metabolizing / regulatory enzymes such as protease were in fact a critical factor. drug targetfor these types of diseases, which coincidentally have been shown to be a critical mechanism of action for several viral diseases such as HIV and hepatitis.

The researchers decided to test all of the company’s compoundspatent portfolio against the SARS-CoV-2 protease and discovered to their surprise that several compounds developed by SyneuRx were potent protease blockers for the SARS-CoV-2 and H1N1 influenza viruses, including the compound that became Pentarlandir has been shown to be the most effective.

Other studies have confirmed Pentarlandirs ability to block coronavirus replication in multiple rigorous cell studies and it has also been shown to maintain an excellent safety profile, making it the best candidate to enter clinical development.

The importance of finding a safe, inexpensive and highly effective oral drug that can treat COVID-19 for people regardless of their risk of progression cannot be overstated, ”said Dr. Guochuan EmileTsai MD PhD MAS, Founder and CEO of SyneuRx. Our researchers have spent several years in the discovery, isolation and development of Pentarlandir and we are very pleased with the progress of the Phase II trial. We are actively developing this drug candidate and remain hopeful that we will continue our positive results to date. “

About SyneuRx:

SyneuRx was founded in 2013 with the aim of using scientific breakthroughs to develop new CNS drugs for patients with severe mental disorders. The multinational team is located in the United States and Taiwan. Before starting SyneuRx, Dr Guochuan (Emil) Tsai, MD, PhD was a faculty member of Harvard Medical School and is now in UCLA Medical School, Department of Psychiatry and Biobehavioural Sciences.

SyneurRx and Pentarlandir are trademarks and registered trademarks, respectively, of SyneuRx International. All trademarks and registered trademarks above are hereby acknowledged and acknowledged.

Disclosure Notice:

The information contained in this press release is as of November 18, 2021. SyneuRx assumes no obligation to update any forward-looking statements contained in this press release as a result of new information or future events or developments.

This press release contains forward-looking information about SyneuRxCOVID-19 as well as influenza and business effortss investigational oral antiviral candidate Pentarlandir® (including qualitative evaluations of available data, potential benefits, expectations for clinical trials, advance purchase agreements, expected timing of data readings, regulatory submissions, approvals or regulatory approvals, planned investments and manufacturing, distribution and supply), involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among others, uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, start and / or completion dates of clinical trials, start dates and / or completion dates regulatory submission, regulatory approval dates and / or launch dates, as well as risks associated with preclinical and clinical data, including the possibility of new adverse preclinical, clinical or safety data and further analysis of the data existing preclinical, clinical or safety; the ability to produce clinical or other comparable results, including the efficacy, safety and tolerability profile observed to date, in additional studies or in larger and more diverse populations after marketing; the risk that preclinical and clinical trial data will be subject to different interpretations and evaluations, including during the peer review / publication process, in the scientific community at large and by regulatory authorities; whether regulatory authorities will be satisfied with the design and results of these future preclinical and clinical studies; if and when drug applications or submissions to request emergency use or conditional marketing authorization for any potential indication of Pentarlandir can be made in all jurisdictions and if obtained, if and when such authorizations emergency use or such licenses will expire or terminate; whether and when regulatory authorities in any jurisdiction can approve such applications for Pentarlandir, which will depend on a myriad of factors, including whether the products benefits outweigh its known risks and product determinations effectiveness and, if approved, will be commercially successful; decisions by regulatory authorities affecting labeling or marketing, manufacturing processes, safety and / or other matters that may affect the availability or commercial potential of Pentarlandir, including product development or therapies by other companies; risks related to the availability of raw materials for Pentarlandir; the risk that we may not be able to create or increase manufacturing capacity in a timely manner or maintain access to logistics or supply channels based on global demand, which would have a negative impact on our ability to deliver the estimated number of Pentarlandir courses within the specified time periods; if and when additional purchasing agreements will be made; the risk that demand for products will be reduced or no longer exist; uncertainties regarding the impact of COVID-19 on SyneuRxs activities, operations and financial results; and competitive developments.

For more information, please contact SyneuRx PR Counsel Jonathan hirshon To [email protected]

SOURCE SyneuRx International

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