RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma's Oral Opaganib Reduces Mortality by 70% Given on Top of Remdesivir and Corticosteroids in Severe COVID-19

RedHill Biopharma's Oral Opaganib Reduces Mortality by 70% Given on Top of Remdesivir and Corticosteroids in Severe COVID-19

Updates on Regulatory Discussions and Plans in Multiple Countries

Prespecified analysis of Phase 2/3 opaganib data in severe COVID-19 patients showed a significant, 70.2% mortality benefit with opaganib by Day 42 when given on top of the best available standard-of-care (SoC), remdesivir and corticosteroids (6.98% mortality in the opaganib arm versus 23.4% for placebo, p-value=0.034)
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A second prespecified analysis showed that opaganib also delivered a significant 34% benefit in 'time to recovery by Day 14', with 37.4% of opaganib-treated patients reaching this event versus 27.9% of patients treated with placebo + SoC (p-value=0.013)--

These additional prespecified mortality and recovery analyses, along with previously announced data showing opaganib's improved median time to SARS-CoV-2 viral RNA clearance, further strengthen the positive outcomes in the Phase 2/3 study post-hoc analysis. All data is being shared with regulators
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Opaganib data submissions initiated in Q4/21, initial guidance on potential path to approval received from the EU's EMA, the U.S. FDA, UK's MHRA and others, discussions ongoing
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Based on regulatory feedback and external advice received from other territories, potential emergency and marketing authorization applications planned in H1/2022

https://finance.yahoo.com/news/redhill-biopharmas-oral-opaganib-reduces-151500444.html

TEL AVIV, Israel and RALEIGH, NC, February 7, 2022 -- InvestorsHub NewsWire -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced results from two recently completed prespecified analyses from the oral opaganib (ABC294640)[1] Phase 2/3 study in hospitalized severe COVID-19. The first analysis showed that opaganib significantly reduced mortality when given to patients who received remdesivir and corticosteroids, the best available standard-of-care (SoC) for hospitalized patients. A second analysis further showed that opaganib delivered a significant benefit in time to recovery, defined as achieving a score of 1 or less on the WHO Ordinal Scale by Day 14. The Company is advancing regulatory discussions in multiple countries, with potential emergency and marketing authorization applications being planned for certain countries in the first half of 2022.

The prespecified mortality analysis, undertaken for all patients from the Phase 2/3 study who were receiving remdesivir and corticosteroids at baseline, demonstrated a significant 70.2% mortality benefit for opaganib-treated patients, with a mortality rate of 6.98% (n=3/43) for the opaganib arm + SoC versus 23.4% (n=11/47) for placebo + SoC by Day 42 (p-value=0.034).

The second prespecified analysis showed opaganib delivered a significant 34% benefit in time to recovery, defined as achieving a score of 1 or less on the WHO Ordinal Scale by Day 14, with 37.4% of opaganib-treated patients (n=86/230) reaching this event versus 27.9% of patients (n=65/233) treated with placebo + SoC (p-value=0.013, Hazard Ratio 1.49)

"These prespecified analyses, along with the recent data showing opaganib's improved median time to viral RNA clearance, provide strong support for the promising results observed in the Phase 2/3 study post-hoc analysis. Oral opaganib has now shown an ability to reduce deaths, speed up recovery and clear viral RNA, all with a safety and tolerability profile similar to placebo. Strikingly, opaganib has delivered these benefits over and above the very best level of current standard-of-care, with patients receiving both remdesivir and corticosteroids," said Dr. Mark Levitt, RedHill's Chief Scientific Officer. "The hospitalized moderate to severe COVID-19 patient group is estimated to represent more than 50% of all hospitalized COVID-19 cases and growing. The prevalence of Omicron, new emerging variants, loss of efficacy of existing drugs against such variants and the difficulty in stopping COVID-19 early enough in its course, despite the availability of new drugs, all point very clearly to the urgent need for new, preferably orally-administered, therapeutic options, unaffected by spike protein mutations, for this underserved and substantial patient population."

Regulatory progress continues to be made, with opaganib data submissions initiated in the fourth quarter of 2021 in the U.S., Europe, UK and additional countries. Discussions remain ongoing and initial guidance on a confirmatory study and potential path to approval has been received from the EU's EMA, the U.S. FDA, UK's MHRA and others. Based on regulatory feedback from other territories and external advice received, the Company is also planning potential emergency and marketing authorization applications in certain such countries in the first half of 2022.

Oral opaganib was studied in a global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840). In a prespecified analysis of all Phase 2/3 study patients with a positive PCR at screening[2] opaganib improved the median time to viral RNA clearance by at least 4 days, achieving viral RNA clearance in a median of 10 days, while the median for clearance was not reached by the end of 14-days treatment in the placebo arm (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463). Additionally, 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.

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.

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 fluids[3].

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.