RedHill Biopharma Gains Approval for Chinese Patent on COVID-19 Treatment RHB-107

RedHill Biopharma Ltd., a biopharmaceutical company focused on the development of drugs for various diseases, has announced a significant milestone in the advancement of their investigational compound, RHB-107 (upamostat). The China National Intellectual Property Administration (CNIPA) has granted a use of composition-of-matter patent for RHB-107, a potential oral treatment for COVID-19. This patent ensures exclusive rights to the molecular structure of RHB-107, extending beyond mere method-of-use claims. The patent specifically covers its application for treating SARS-CoV-2, including both wild-type and numerous emerging variants, thereby reinforcing RedHill's strategic presence in the global COVID-19 therapeutic market, projected to exceed $3 billion by 2025.

Guy Goldberg, RedHill's Chief Business Officer, emphasized the significance of this patent in enhancing the company's intellectual property portfolio. He highlighted that the patent not only provides extensive protection for RHB-107's structure but also strengthens RedHill's market positioning in Asia, an essential pharmaceutical hub. Goldberg noted that RHB-107 represents a novel antiviral candidate potentially offering a critical oral treatment option for early-stage COVID-19 in non-hospitalized populations, which remains a substantial risk for vulnerable individuals.

The efficacy of RHB-107 has been demonstrated in a U.S.-based Phase 2 clinical trial, where it met its primary endpoint of safety and tolerability. The trial, involving COVID-19 patients, showed a 100% reduction in hospitalization rates within the RHB-107 treatment group compared to the placebo group. Additionally, RHB-107 treatment resulted in an 88% reduction in the development of new severe COVID-19 symptoms post-treatment initiation. These promising results suggest a faster recovery period for patients treated with RHB-107, with a median recovery time of three days, compared to eight days for those on a placebo. Further clinical data is anticipated from the PROTECT study, which is funded externally and supported by the U.S. Department of Defense.

RHB-107 is characterized as a host-directed antiviral agent that is administered orally once daily. Its mechanism of action involves targeting human serine proteases, which are integral in preparing the viral spike protein for cellular entry. This approach allows RHB-107 to potentially retain efficacy against viral variants with spike protein mutations. The drug has demonstrated a favorable safety profile, with minimal adverse reactions reported in clinical trials.

Beyond its application in COVID-19, RHB-107 is being explored for broader antiviral activities and other therapeutic indications, including cancer and inflammatory gastrointestinal diseases. RedHill acquired the rights for RHB-107, excluding China, Hong Kong, Taiwan, and Macao, from Heidelberg Pharma AG. The company has conducted several Phase 1 and Phase 2 studies, underscoring the compound's clinical safety in approximately 200 patients.

RedHill Biopharma continues to focus on the development and commercialization of specialty pharmaceuticals for gastrointestinal and infectious diseases, as well as oncology. In addition to RHB-107, the company is advancing several other late-stage clinical programs, including opaganib, RHB-204, RHB-104, and RHB-102. RedHill also promotes Talicia, an FDA-approved treatment for Helicobacter pylori infection, with plans for further market expansion.

With this recent patent approval and promising clinical outcomes, RedHill Biopharma is poised to make a significant impact in the treatment landscape for COVID-19 and other diseases, potentially offering new therapeutic options to patients globally.