RedHill Biopharma Ltd. (NASDAQ:RDHL) has announced the receipt of two Notices of Allowance from the US Patent and Trademark Office (USPTO) covering opaganib and RHB-107 (upamostat), as methods for the treatment of coronavirus (COVID-19) caused by the SARS-CoV-2 virus.
Opaganib and RHB-107 are both novel COVID-19 therapeutic candidates, in oral pill form, with dual mechanism of action effects. Both are host-targeted and are therefore expected to be effective against emerging viral variants with various mutations in the spike protein.
In a statement, Danielle T. Abramson, VP, Intellectual Property & Research at RedHill said: "There is an urgent need for oral COVID-19 treatments for patients inside and outside of the hospital setting."
READ: RedHill Biopharma reports its Phase 2/3 study of opaganib in patients with severe COVID-19 pneumonia passes fourth Data Safety Monitoring Board review
"With two novel oral COVID-19 therapeutics in late clinical-stage development, RedHill stands at the forefront of research for COVID-19 treatments. We are very pleased with the new intellectual property protection which extends until at least 2041. The Company has also filed for protection under the Patent Cooperation Treaty (PCT) and has the option of applying in the member countries thereof," Abramson added.
Enrollment in opaganib's global Phase 2/3 study in hospitalized patients with severe COVID-19 (NCT04467840) is almost 100% complete. RHB-107's Phase 2/3 study is ongoing in non-hospitalized patients with symptomatic COVID-19 (NCT04723527) who do not require supplemental oxygen. Together, this covers potential treatment for the vast majority of affected patients.
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity, that is host-targeted and are therefore expected to be effective against emerging viral variants. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
It is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a 40- patient US Phase 2 study. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, and has shown decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.
RHB-107 is a proprietary, first-in-class, orally-administered potent inhibitor of several serine proteases, with antiviral and potential tissue-protective effects. RHB-107 is also host-targeted and are therefore expected to be effective against emerging viral variants. RHB-107 is being evaluated in a US Phase 2/3 study for treatment of non-hospitalized patients with symptomatic COVID-19 who do not require supplemental oxygen.
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