SyneuRx Announces Final Results from Phase 2 Clinical Trial of COVID-19 Oral Antiviral Candidate Pentarlandir® (SNB01) | Company

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LOS ANGELES & NEW TAIPEI CITY, Taiwan–(BUSINESS WIRE)–July 31, 2022–

SyneuRx™ International (TPEX:6575), a global biotechnology company focused on developing new classes of drugs for COVID-19 and several major central nervous system disorders, today announced results from its phase-stage clinical trial 2 evaluating the efficacy and safety of SNB01 (Pentarlandir), a novel oral COVID-19 antiviral candidate.

Eighty-nine participants with breakthrough or unvaccinated cases of COVID-19 were randomized equally into high-dose, low-dose, and placebo groups. The phase 2 study showed that Pentarlandir can reduce inflammation caused by COVID and improve overall health. In five of the six inflammatory markers studied, the Pentarlandir treatment groups showed either statistical signals of greater reductions in inflammatory markers or a clear trend of greater reductions. Many secondary parameters also showed encouraging trends. In particular, the Pentarlandir treatment groups showed greater improvement in general health. In terms of clinical symptoms, the Pentarlandir groups were associated with a greater reduction in total COVID-19 symptoms over the longer term (between two to eight weeks after randomization) than the placebo group. On average, the Pentarlandir groups were associated with fewer days of worsening symptoms in half of the 24 COVID symptoms measured.

Pentarlandir was very well tolerated in the high and low dose groups with no serious adverse effects. There were a limited number of adverse events overall (15%), most of which were mild. Only a few cases (4%) were related to the treatment drug. Higher dose treatment did not cause more treatment-related adverse events. There were no cases of hospitalization, death, or study discontinuation due to adverse events.

“We are strongly encouraged by the results of this successful proof-of-concept study. These results not only help us better design the next Phase 3 study, but also have great clinical implications,” said Emil Tsai, MD, Ph.D., MAS, 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 also brought promise to the recent call for new COVID-19 treatment options as concerns about rebounds and resistance to existing antivirals emerge.

Tsai continued, “We expect COVID to remain long-term and inflict morbidity and mortality on millions of people, much like what OC43 and H1N1 have been doing in the human population for many years. . And there will be more zoonotic diseases to come. We are committed to evaluating the targeting potential of protease inhibitor and other potential critical drug targets to address the ongoing challenge of treatment resistance in vulnerable patients. By examining the structure of these targets, keeping an eye out for where resistant variants might develop, we intend to improve 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 be expanded to evaluate the broad-spectrum antiviral activity of Pentarlandir in inhibiting SARS-CoV-2 as well as influenza viruses, including rigorous safety assessments, to be ready for potential coincident flu and COVID-19 outbreaks.

To learn more about the Pentarlandir clinical trial, visit clinicaltrials.gov (NCT number: NCT04911777).

For more information about SyneuRx, visit syneurx.com.

About Pentarlandir

After years of research into how several debilitating diseases of the central nervous system work, SyneuRx scientists arrived at the theory that regulatory enzymes such as protease are a critically important “drug target” for these types of diseases, which, coincidentally, is also a target for several viral diseases such as HIV and hepatitis. The researchers decided to test all of the compounds in the company’s patent portfolio against protease and found that several compounds developed by SyneuRx were potent protease blockers, of which the compound that became Pentarlandir was found to be the safest and most effective in preclinical testing. SyneuRx has confirmed its ability to block coronavirus replication in multiple rigorous cell studies and has also been shown to maintain an excellent safety profile, making Pentarlandir an ideal candidate to enter clinical development. . SyneuRx found that Pentarlandir can also block the replication of several influenza viruses in a cell test. The company continues to test the effectiveness of Pentarlandir against other potentially deadly virus strains.

About SyneuRx

SyneuRx International (TPEX:6575) is a global clinical-stage biotechnology company focused on developing new classes of drugs for COVID-19 and several major central nervous system (CNS) diseases. Founded in 2013, SyneuRx is poised to bring breakthrough pharmaceuticals to market with a strong and promising pipeline of seven investigational drugs for CNS disorders and two for COVID-19 – eight of which are currently in Phase 2 and Phase 3 trials. clinics with the US Food and Drug Administration. The company’s mission is to infuse a scientific and humanistic approach in its research and development of safe, effective and accessible therapies for patients suffering from disorders such as schizophrenia, dementia and depression, as well as COVID-19. and other RNA-encoded viruses. . Dedicated to taking a safety-focused approach with its research and development focusing on well-established lead compounds as well as natural sources and herbal substances to treat or prevent disease, SyneuRx has received Breakthrough Therapy designations and FDA orphan drug designations for two of its new CNS therapies. To learn more, visit syneurx.com.

Notice of Disclosure

The information in this release is as of July 31, 2022. SyneuRx undertakes no obligation to update any forward-looking statements contained in this release as a 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 influenza and the company’s investigational oral antiviral candidate Pentarlandir® (including qualitative assessments of available data, potential benefits, expectations for clinical trials, advance purchase agreements, timing of data reads, regulatory submissions, regulatory approvals or clearances, planned investments and planned manufacturing, distribution and supply), involving risks and substantial 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 achieve anticipated clinical endpoints, dates of commencement and/or completion of clinical trials, dates of 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 additional analyzes of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the efficacy, safety and tolerability profile observed to date, in additional studies or in larger and more diverse post-marketing populations; the risk that preclinical and clinical trial data will be subject to differing interpretations and assessments, including during the peer review/publication process, in the broader scientific community and by regulatory authorities; whether regulatory authorities will be satisfied with the design and results of such future preclinical and clinical studies; if and when drug applications or submissions to seek emergency use or conditional marketing authorization for any potential indication of Pentarlandir may be filed in any jurisdictions and if and if obtained, such authorizations emergency use certificates or licenses will expire or terminate; whether and when regulatory authorities in all jurisdictions may approve such Pentarlandir applications, which will depend on a myriad of factors, including determining whether the product’s benefits outweigh its known risks and determining the product’s efficacy and , if approved, whether it will be commercially successful; decisions of regulatory authorities impacting 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 build or increase manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand, which would adversely impact our ability to deliver the estimated number of Pentarlandir courses within the expected time periods; if and when additional purchase agreements will be entered into; the risk that demand for products will be reduced or no longer exist; uncertainties regarding the impact of COVID-19 on SyneuRx’s business, operations and financial results; and competitive developments.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20220731005043/en/

CONTACT: SyneuRx Press Office

(818) 696-8800

[email protected]

KEYWORD: UNITED STATES TAIWAN NORTH AMERICA ASIA PACIFIC CALIFORNIA

INDUSTRY KEYWORD: PHARMACEUTICAL BIOTECHNOLOGY GENERAL HEALTH HEALTH COVID-19 INFECTIOUS DISEASES HEALTH TECHNOLOGY CLINICAL TRIALS

SOURCE: SyneuRx International

Copyright BusinessWire 2022.

PUBLISHED: 7/31/2022 7:00 PM / DISK: 7/31/2022 7:02 PM

http://www.businesswire.com/news/home/20220731005043/en

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