RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced receipt of two Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) covering opaganib and RHB-107 (upamostat) as methods for the treatment of COVID-19 caused by the SARS-CoV-2 virus.
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 Danielle T. Abramson, Ph.D., VP, Intellectual Property & Research at RedHill. “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.”
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 U.S. Evaluations and discussions continue with the FDA, EMA and regulators in other countries.