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 her...
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