TEL-AVIV, Israeland RALEIGH, NC, March 15, 2022 / PRNewswire / – RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or “The Company”), a specialized biopharmaceutical company, announced that it has entered into an exclusive licensing agreement with Kukbo Co. Ltd. (Kospi: 001140) (“Kukbo”), a South Korean company, for oral opaganib for the treatment of COVID-19, i South Korea.
Subject to the terms of the license agreement, as follows previously announced strategic investment of Kukbo, RedHill will receive a prepayment of $ 1.5 million and is entitled to 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 acquires the exclusive rights to commercialize opaganib in South Korea for COVID-19.
Dror Ben-AsherRedHills CEO, said: “South Korea is currently experiencing an increase in COVID-19 cases with Korea Disease Control & Prevention Agency reports nearly 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 see an average of almost 2,000 people hospitalized because of COVID-19 in South Korea and we desperately need medicines that can effectively treat these patients, “ said Hyun HaKukbo’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 collaboration with Kukbo also includes a first-instance for RedHill’s late-stage clinical assets, opaganib, RHB-107 (upamostat) and Talicia®for one or more of the territories of South Korea, Japan, Indonesia, Vietnam, Thailand and or Malaysia. The right of tender 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-class, orally administered, selective sphingosine kinase-2 (SK2) inhibitor with proposed dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against new viral variants that have already shown inhibition against concern variants, e.g. Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis and has the potential to target several oncological, viral, inflammatory and gastrointestinal indications.
In pre-specified analyzes of clinical phase 2/3 data, oral opaganib has shown improved viral RNA clearance, significant reduction in mortality in addition to remdesivir and corticosteroids, and faster recovery time. Opaganib has previously provided promising US phase 2 data in patients with moderate to severe COVID-19, submitted for peer review and recently published in medRxiv.
Opaganib has also received an Orphan Drug designation from the US 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 accumulation, treatment, and analysis in this study are ongoing.
Opaganib showed potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, and inhibits viral replication of the original SARS-CoV-2 and variants tested to date in a in vitro model of human pulmonary bronchial tissue. In addition, preclinical in vivo studies have shown the potential of opaganib to reduce renal fibrosis, have shown reduced mortality due to influenza virus infection and amelioration of bacterial-induced pneumonia lung damage with reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.
The ongoing clinical trials with opaganib are registered at www.ClinicalTrials.gova web-based service from the US National Institutes of Health that provides public access to information on publicly and privately supported clinical trials.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialized biopharmaceutical company focusing primarily on gastrointestinal and infectious diseases. RedHill promotes gastrointestinal drugs, Movantik® for opioid-induced constipation in adults, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adultsand Aemcolo® for the treatment of traveler’s diarrhea in adults. RedHill’s late-stage key clinical development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacterial (NTM) disease; (ii) opaganib (ABC294640)a first–in–class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma underway; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a US phase 2/3 study as a treatment for symptomatic COVID-19 and targeted at several other cancers and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first phase 3 study for Crohn’s disease; (v) RHB-102, with positive results from a phase 3 study for acute gastroenteritis and gastritis and positive results from a phase 2 study for IBS-D; and we) RHB–106, an encapsulated intestinal preparation. More information about the company can be found at www.redhillbio.com/ twitter.com/RedHillBio.
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 “intend”, “may”, “will”, “planner”, “expect,” anticipate “,” projects “,” predicts “,” estimates “,” measures “,” believes “,” hopes “,” potential “or similar words and includes the plan for potential emergencies and applications for marketing authorizations in certain eg US countries in the first half of 2022. 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 as a result actual results may differ materially from those expressed or Such risks and uncertainties include the Phase 2/3 COVID-19 study for opaganib and its results may not be sufficient for regulatory applications, h including emergency use or marketing applications, and that further COVID-19 studies on opaganib are likely to be required by regulatory authorities to support such potential applications and use or marketing of opaganib to COVID-19 patients that emergency applications and marketing authorizations in certain past US countries will be delayed that opaganib will not be effective against new viral variants as well as risks and uncertainties associated with (i) the commencement, timing, progress and results of the company’s research, manufacturing, preclinical studies, clinical trials and other therapeutic candidate development efforts, and the timing for the commercial launch of its commercial products and those, it may. acquire or develop in the future; (iii) the ability of the company to advance its therapeutic candidates for clinical trials or to complete its preclinical or clinical trials; (iii) the scope and number and type of additional studies that the company may be required to perform and the company’s reception of regulatory approvals of its therapeutic candidates and the timing of other regulatory applications, approvals and feedback; (iv) manufacturing, clinical development, commercialization and market acceptance of the company’s therapeutic candidates and Talicia®; (v) the ability of the company to successfully commercialize and promote Movantik®Talicia® and Aemcolo®; (vi) the ability of the company to establish and maintain business partnerships; (vii) the ability of the Company to acquire products approved for marketing in the United States that achieve commercial success and build and maintain its own marketing and commercialization capabilities; (viii) the interpretation of the characteristics and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) implementation of the company’s business model, strategic plans for its business and therapeutic candidates; (x) the extent of the protection that the company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products, and its ability to conduct its business without infringing the intellectual property rights of others; (xi) parties from whom the company licenses its intellectual property who breach their obligations to the company; (xii) estimates of business expenses, future income, capital requirements and the need for additional financing; (xiii) the impact of patients suffering from adverse events using study medications under the company’s extended access program; and (xiv) competition from other companies and technologies within the company’s industry. More detailed information about the company and the risk factors that may affect the realization of forward-looking statements are provided in the company’s filing with the Securities and Exchange Commission (SEC), including the company’s annual report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are provided only from the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law.
 Opaganib is a new drug that is not available for commercial distribution.
 RHB-107 (upamostat) is a new experimental drug that is not available for commercial distribution.
 Xia C. et al. Transient inhibition of sphingosine kinases provides protection for 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 pneumonia damage. Thorax. Jun 2019; 74 (6): 579-591.
 Full prescription information for Movantik® (naloxegol) is available at: www.Movantik.com.
 Full prescription information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) are available at: www.Talicia.com.
 Full prescription information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
SOURCE RedHill Biopharma Ltd.