On March 15, 2022 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it has entered into an exclusive license agreement with Kukbo Co. Ltd. (Kospi: 001140) ("Kukbo"), a South Korean corporation, for oral opaganib1 for the treatment of COVID-19, in South Korea (Press release, RedHill Biopharma, MAR 15, 2022, View Source [SID1234610086]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the license agreement, which follows the previously announced strategic investment by Kukbo, RedHill will receive an upfront payment of $1.5 million and is eligible for up to $5.6 million in milestone payments as well as low double-digit royalties on net sales of oral opaganib in South Korea. Kukbo will receive the exclusive rights to commercialize opaganib in South Korea for COVID-19.

Dror Ben-Asher, RedHill’s CEO, said: "South Korea is currently experiencing a spike in COVID-19 cases with the Korea Disease Control & Prevention Agency reporting almost 4 million new cases already registered in the first half of March alone. Together with our partner, Kukbo, we are working hard to bring opaganib to Korean patients in need of new COVID-19 therapeutic options."

"Every day this month we are seeing an average of almost 2000 people hospitalized due to COVID-19 in South Korea and we desperately need medications that can effectively treat these patients," said Hyun Ha, Kukbo’s CEO. "With the data supporting opaganib for COVID-19, and the expanded partnership with RedHill, Kukbo is determined to work with local regulators with the aim of bringing opaganib to South Korean patients, as soon as possible."

The partnership with Kukbo also includes a right of first offer for RedHill’s late-stage clinical assets, opaganib, RHB-107 (upamostat)2 and Talicia, for one or more of the territories of South Korea, Japan, Indonesia, Vietnam, Thailand and/or Malaysia. The right of first offer has been extended as part of the new license agreement until the end of October 2022.

About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with proposed dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

In prespecified analyses of Phase 2/3 clinical data, oral opaganib has demonstrated improved viral RNA clearance, significant mortality reduction on top of remdesivir and corticosteroids and faster time to recovery. Opaganib previously delivered promising U.S. Phase 2 data in patients with moderate to severe COVID-19, submitted for peer review and recently published in medRxiv.

Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in this study are ongoing.

Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib’s potential to decrease renal fibrosis, have shown decreased fatality rates from influenza virus infection, and amelioration of bacteria-induced pneumonia lung injury with reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids3.

The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.