SyneuRx Announces Oral COVID-19 Twindemic Antiviral Drug Candidate Pentarlandir Has Entered Final Portion of FDA Phase II Testing

SyneuRx™ International, (Taipei Exchange, ticker ID TT6575, www.syneurx.com), a pioneering developer of novel CNS (Central Nervous System) and anti-viral pharmaceuticals, today announced that its investigational oral SARS-CoV-2 (COVID-19) anti-viral drug candidate Pentarlandir® has successfully been in Phase II US-FDA trial for several months and is nearing Phase III in 2022.

Designed as an early-stage COVID-19 treatment, Pentarlandir is given by mouth to patients suffering either from 'breakthrough' cases of COVID-19 (for those who have been previously vaccinated or infected) or potentially as a first-line treatment pathway for the unvaccinated who might otherwise face potential hospitalization and death. SyneuRx has previously received 'Breakthrough Therapy Designation and Orphan Drug Designation' grants by the FDA for its CNS drug candidates.

Pentarlandir is based on highly-purified isomers of tannic acid and is derived from a botanical origin (just like Tamiflu®, which is itself purified from a chemical found in Star Anise). Pentarlandir specifically targets main protease, or 3CL-protease, which turns baseline viral protein into the necessary building blocks that enable the replication of new viral particles and also inhibits TMPRSS2 for viral entry. Pentarlandir acts on not just the serine protease TMPRSS2, but also HAT (both of which are critical for the entry of influenza-type viruses into cells). Therefore, it holds promise as a therapeutic tool for 'twindemic' scenarios (treatment of both COVID-19 and Influenza endemics).

If successfully developed, SyneuRx intends to make Pentarlandir available to the world's developing nations as part of the United Nations-backed Medicines Patent Pool. Pentarlandir is projected to be widely-available worldwide within 12-24 months following phase III under current factory availability.

More information about the Pentarlandir Phase II 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 operate, SyneuRx scientists arrived at the theory that metabolizing/regulating enzymes such as protease were in fact a critically-important 'drug target' for these types of illnesses, which coincidentally have proven to be a critical mechanism of action for several virally-caused diseases such as HIV and Hepatitis.

Researchers decided to test all the compounds in the company's patent portfolio against the SARS-CoV-2 protease and found to their surprise that several SyneuRx-developed compounds were potent protease blockers for both SARS-CoV-2 and H1N1 influenza viruses, of which the compound that became Pentarlandir proved to be the most efficacious.

Further studies confirmed Pentarlandir's ability to block coronavirus replication in multiple, rigorous cellular studies and it also proved to maintain an excellent safety profile, which made it the best candidate to go into clinical development.

"The importance of finding a safe, inexpensive and highly-efficacious oral drug capable of treating COVID-19 for people regardless of their risk of progression cannot be overstated," said Dr. Guochuan 'Emil' Tsai MD PhD MAS, founder and CEO of SyneuRx. "Our researchers have devoted several years to 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 candidate drug and remain hopeful that we will continue our positive track record to date."

About SyneuRx:

SyneuRx was founded in 2013 with the goal of using scientific breakthroughs to develop novel CNS drugs for patients suffering from severe mental health disorders.  The multi-national team is located in the U.S. and Taiwan, China. Prior to starting SyneuRx, Dr. Guochuan (Emil) Tsai, MD, PhD was a member of the faculty at Harvard Medical School and is now at the UCLA School of Medicine, Department of Psychiatry and Biobehavioral Sciences.

SyneurRx and Pentarlandir are trademarks and registered trademarks, respectively, of SyneuRx International. All previous trademarks and registered trademarks previously cited are hereby recognized and acknowledged. 

Disclosure Notice:

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

This release contains forward-looking information about SyneuRx's efforts to combat COVID-19 as well as flu and the company's investigational oral antiviral candidate Pentarlandir® (including qualitative assessments of available data, potential benefits, expectations for clinical trials, advanced purchase agreements, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations, planned investment and anticipated 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 other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results including efficacy, safety and tolerability profile observed to date, in additional studies or in larger, more diverse populations following commercialization; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any drug applications or submissions to request emergency use or conditional marketing authorization for any potential indications for Pentarlandir may be filed in any jurisdictions and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when regulatory authorities in any jurisdictions may approve any such applications for Pentarlandir, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pentarlandir, including development of products 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 scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand, which would negatively impact our ability to supply the estimated numbers of courses of Pentarlandir within the projected time periods; whether and when additional purchase agreements will be reached; the risk that demand for any products may be reduced or no longer exist; uncertainties regarding the impact of COVID-19 on SyneuRx's business, operations and financial results; and competitive developments.

For further information, please contact SyneuRx PR Counsel Jonathan Hirshon at jh@horizonpr.com

Source: SyneuRx Internationa