RedHill Biopharma Receives Allowances for U.S. Patent Applications Covering Opaganib and RHB-107 for COVID-19
- The two patents protect opaganib and RHB-107 for the treatment of COVID-19 until at least 2041 once granted
- Enrollment in opaganib's global Phase 2/3 study in hospitalized patients with severe COVID-19 is almost 100% complete
- RHB-107's ongoing Phase 2/3 study is enrolling U.S. non-hospitalized patients with symptomatic COVID-19 that do not require supplemental oxygen
- Opaganib and RHB-107 are novel, oral, host-targeted drug candidates expected to be effective against emerging viral variants
- Opaganib and RHB-107 potentially cover the vast majority of affected COVID-19 patients
Both opaganib and RHB-107 are 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.
"There is an urgent need for oral COVID-19 treatments for patients inside and outside of the hospital setting," said
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.
In view of the upcoming completion of enrollment, RedHill is evaluating the regulatory path for opaganib with a focus on those countries currently most affected by COVID-19. The regulatory path, including potential submissions of emergency use applications in those countries, is subject to whether the data generated by the ongoing Phase 2/3 study is sufficiently positive and supportive as well as the specific requirements in each country. The strength of the safety and efficacy data generated from the opaganib studies will be key to regulatory applications. Additional studies to support the potential of such applications and the use or marketing of opaganib are likely to be required. For example, the FDA has indicated we will need to complete additional studies to support applications in the
About Opaganib (Yeliva®, ABC294640)
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 targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib 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
Opaganib has also received Orphan Drug designation from the
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.
Originally developed by
The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the
About RHB-107 (upamostat)
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 targets human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a
About RedHill Biopharma
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk of a delay in completion of enrollment for the Phase 2/3 COVID-19 study for opaganib and the Phase 2/3 COVID-19 study for RHB-107, delay in top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib and the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required, and for RHB-107 may be required, by regulatory authorities to support such potential applications and the use or marketing of opaganib and/or RHB-107, as the case may be, for COVID-19 patients, that opaganib and RHB-107 will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the
Chief Corporate & Business Development Officer
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 Opaganib is an investigational new drug, not available for commercial distribution.
 RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.
 Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.
 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.