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David v Goliath in The Race to Develop an Oral Therapy for COVID-19

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Photo by Towfiqu barbhuiya on Unsplash

Broad agreement in the world of science can be a rarity. However, one thing that public health leaders active in the fight against COVID-19 can agree on, is the urgent need for oral, pill-based treatments that are effective at halting disease progression, can get — and keep — people out of the hospital and can reduce mortality. One key group of COVID-19 patients who are in desperate need of treatment options are those moderately severe patients in hospital who are at high risk of becoming critically ill, and for whom most drugs have so far failed to deliver.

A slew of promising drug candidates from big pharma such as Merck & Co. Inc. (NYSE: MRK), Roche Holdings AG (OTC: RHHBY), and Pfizer Inc. (NYSE: PFE) have so far either tried, and failed, to benefit this key majority group of hospitalized patients or are focused on managing much milder disease, in the outpatient setting, limited to within a few days from infection.

However, a small, Israeli/U.S. upstart, RedHill Biopharma Ltd. (NASDAQ: RDHL), has quietly raced to the front of the pack for a novel COVID pill with its two-pronged oral development program - one of which, opaganib, has just posted late-stage clinical data showing impressive mortality reduction figures in the underserved hospitalized patient population with moderately severe COVID-19.

RedHill believes this new data for its oral COVID-19 pill, opaganib, puts it ahead of some of the pharma behemoths who have struggled to show a benefit in hospitalized patients, outside of the earliest stages of disease. Moreover, opaganib, a sphingosine kinase-2 (SK2) inhibitor with a dual antiviral and anti-inflammatory action that targets human enzymes in cells in the body rather than the virus itself, has also delivered pre-clinical data demonstrating potent antiviral inhibition of SARS-CoV-2 variants, including the Beta, Gamma and Delta.

RedHill has recently reported new data from a post-hoc analysis of 251 hospitalized moderately severe COVID-19 pneumonia patients from its opaganib global Phase 2/3 study showing that treatment with opaganib versus the placebo-controlled arm resulted in a 62% reduction in mortality (nominal p-value=0.019). The new data also showed a 21% efficacy benefit with opaganib in reaching room air by Day 14, the study primary endpoint (nominal p-value=0.033), and a median four day benefit to hospital discharge for opaganib-treated patients vs. placebo (10 days for opaganib arm vs. 14 days for placebo; nominal p-value=0.0195). The moderately severe group comprised 53% of study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline (inhaled supplemental oxygen via nasal cannula or face mask).

RedHill believes that the new data makes oral opaganib a potential game-changer and, if approved, has the potential to save lives. RedHill is optimistic about opaganib for several reasons, including:

  • Easy to take, make and distribute oral pill formulation

  • A dual mechanism of action — antiviral and anti-inflammatory — acting on the viral cause and inflammatory effects of COVID-19

  • It inhibits a human host factor, not the virus itself, and has shown preclinically to be effective against variants including Beta, Gamma and Delta

  • Manufacturing scale-up capability and product stability data in place

  • Advanced clinical development with previous positive U.S. Phase 2 trial data and encouraging compassionate use in Israel and Switzerland

  • Good safety based on extensive database from additional oncology studies

RedHill promotes 3 U.S. Food and Drug Administration approved drugs with its experienced U.S. sales team and has built an advanced R&D pipeline of proprietary late-stage clinical development drug candidates.

For more information on RedHill Biopharmaceutical, go to www.redhillbio.com.

Disclaimer: This content has been provided pursuant to a commercial agreement under which RedHill Biopharma paid a fee to the publisher.

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