RedHill Biopharma, an Israel-based biopharmaceutical firm, said Wednesday that it signed an exclusive license agreement with Kukbo, a Korean company, for opaganib, an oral Covid-19 treatment.
Under the agreement, RedHill will receive a $1.5 upfront payment and up to $5.6 million in milestone payments. Also, the company will receive double-digit royalties on net sales of oral opaganib in Korea.
Kukbo gets the exclusive rights to commercialize opaganib for the treatment of Covid-19 in Korea.
Opaganib is a sphingosine kinase-2 (SK2) selective inhibitor. SK2 is a critical component of the replication-transcription complex of many viruses, and blocking SK2 is known to suppress viral replication.
Opaganib demonstrated encouraging data from a phase 2 clinical trial in moderate and severe Covid-19 patients. Also, opaganib obtained the U.S. FDA’s orphan drug designation to treat cholangiocarcinoma.
Opaganib proved antiviral effects against SARS-CoV-2. In an in vitro human lung bronchial tissue model, opaganib inhibited replication of all SARS-CoV-2 variants tested to date, RedHill said.
In preclinical in vivo studies, opaganib suggested its potential to improve inflammatory lung diseases like pneumonia, decrease renal fibrosis, reduce fatality rates from influenza virus infection, and relieve bacteria-induced pneumonia lung injury with lowered levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids, according to the company.
RedHill CEO Dror Ben-Asher said, "South Korea is currently experiencing a spike in Covid-19 cases with the Korea Disease Control and 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."
Ha Hyun, CEO of Kukbo, noted that the nation witnessed an average of 2,000 people hospitalized for Covid-19 infection. Koreans needed a treatment that could effectively treat these patients.
“With the data supporting opaganib for Covid-19, and the expanded partnership with RedHill, Kukbo is determined to work with local regulators to bring opaganib to South Korean patients as soon as possible."
The agreement between RedHill and Kukbo includes a right of the first offer for RedHill’s late-stage pipelines, opaganib, RHB-107 (upamostat), and Talicia, for one or more of the territories of Korea, Japan, Indonesia, Vietnam, Thailand, and Malaysia.
The right of the first offer has been extended until the end of October 2022 under the new license agreement.