Press by SyneuRx
Positive results show Pentarlandir is safe and effective in patients with mild-to-moderate COVID-19
SyneuRx™ International (TPEX:6575), a global biotech company focused on the development of new classes of drugs for COVID-19 and multiple major central nervous system disorders, today announced results from its phase 2 clinical trial evaluating the efficacy and safety of SNB01 (‘Pentarlandir’), a novel COVID-19 oral antiviral candidate.
Eighty-nine participants suffering from breakthrough or unvaccinated cases of COVID-19 were randomized evenly into high-dose, low-dose, and placebo groups. The phase 2 study showed that Pentarlandir can reduce the inflammation caused by COVID and improve overall health. In five out of six inflammatory markers studied, Pentarlandir treatment groups showed either statistical signals of greater reductions in the inflammatory markers or a clear trend of greater reductions. Many secondary endpoints also showed encouraging trends. In particular, the Pentarlandir treatment groups exhibited greater improvement in overall health status. In terms of clinical symptoms, Pentarlandir groups were associated with a greater reduction in total COVID-19 symptoms in the longer run (between two to eight weeks after randomization) than the placebo group. On average, Pentarlandir groups were associated with less days of worsening symptoms in half of the 24 COVID symptoms measured.
Pentarlandir was very well tolerated in both high- and low-dose groups with no serious adverse event. There were a limited number of adverse events overall (15%), most of which were mild in intensity. Only a few cases (4%) were related to the treatment drug. Higher dose treatment did not elicit more treatment-related adverse events. There were no cases of hospitalization, death, or discontinuation of the study due to adverse events.
“We are strongly encouraged by the findings of this successful proof-of-concept study. These findings not only help us better design the forthcoming phase 3 study, but also have great clinical implications,” said Emil Tsai, M.D., Ph.D., M.A.S., founder and CEO of SyneuRx. “Pentarlandir shows potential to treat COVID and/or prevent multisystem inflammatory syndrome, a very serious condition associated with COVID. The study results have also brought promise to the recent call for new COVID-19 treatment options as concerns of rebounds and resistance to existing antivirals emerge.”
Tsai continued, ”We expect that COVID stays around in the long-term and inflicts morbidity and mortality on millions, much like what OC43 and H1N1 have been doing in the human population for many years. And, there will be more zoonotic illnesses to come. We are committed to evaluating the potential of targeting the protease inhibitor and other potential crucial drug targets to address the ongoing challenge of treatment resistance in vulnerable patients. By looking at the structure of these targets, with an eye to where resistant variants might develop, we intend to improve upon the current standard of care.”
SyneuRx is expected to launch the phase 3 study in the coming months. An optimal dose will be selected and the scope will expand to evaluate Pentarlandir’s broad-spectrum antiviral activity in inhibiting SARS-CoV-2 as well as influenza viruses, including rigorous safety assessments, to be ready for the potential coinciding surges of flu and COVID-19.