RedHill Biopharma announces positive results from phase 2/3 study of oral opaganib to treat severely ill hospitalized Covid-19 patients

RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced new data from a prespecified analysis of all oral opaganib's phase 2/3 study patients with positive PCR at screening, demonstrating that opaganib improved the median time to viral RNA clearance by at least 4 days. Treatment with opaganib resulted in viral RNA clearance in a median of 10 days while the median for clearance in the placebo arm was not reached by the end of 14-days treatment for placebo (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463). "Opaganib is the first oral novel drug candidate to demonstrate SARS-CoV-2 viral RNA clearance in hospitalized patients with severe Covid-19 pneumonia. It also provides the first clinical demonstration of opaganib's potential antiviral activity, supporting the 62% reduction in mortality seen in the post-hoc analysis of a large subset of patients from the phase 2/3 study and confirming the viral inhibition observed in preclinical testing against Delta and other variants," said Dr. Mark Levitt, RedHill's chief scientific officer. "It is important to note that these results were achieved in a severely ill hospitalized patient population and following an 11-day median time from onset of symptoms - an entirely different patient population from the mild-moderate outpatients with less than 5 days from symptom onset, for whom oral antivirals have been recently approved. It is also important to keep in mind that as opaganib's proposed mechanism of action targets a host factor, its activity is not expected to be affected by mutations in the spike protein emerging with new viral variants, including Omicron." Opaganib was studied in a global phase 2/3 study in hospitalized patients with severe Covid-19 pneumonia (NCT04467840) with positive PCRs at screening obtained for 437 out of 463 patients (the remaining patients could not be included in this prespecified analysis due to lack of PCR results at screening). Results from a post-hoc analysis of data from 251 study participants requiring a Fraction of inspired oxygen (FiO2) up to and including 60% at baseline (54% of the study participants) demonstrated that treatment with oral opaganib resulted in a 62% reduction in mortality as well as improved outcomes in time to room air, median time to hospital discharge, and likelihood of intubation and mechanical ventilation in this large group of hospitalized, moderately severe Covid-19 patients. RedHill is vigorously pursuing the development program for opaganib and is in ongoing discussions with multiple regulatory agencies regarding potential pathways to approval. 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 strong inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications. Opaganib previously delivered positive 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 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 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 by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids. RedHill Biopharma Ltd. is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases.

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