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RedHill's Novel Late-Stage Pills Hold Promise Against COVID-19 and its Variants

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Photo by Elsa Olofsson on Unsplash

World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus recently said the COVID-19 pandemic's second year was on track to be its deadliest.

Although vaccines have been rolled out in many parts of the world, experts suggest that it will take time to vaccinate 70% of the global population given the pace of vaccination drives, the shortage in production and logistical challenges.

Today, the need for a breakthrough in therapeutics that is simple, effective, safe and easy to distribute is paramount as it may help physicians treat patients at different stages of the disease progression.

RedHill Biopharma (NASDAQ: RDHL), a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases, has stepped up to the challenge with its two novel oral pills in late-stage development for COVID-19, opaganib and RHB-107.

Opaganib (Yeliva®, ABC294640) is a first-in-class orally-administered sphingosine kinase-2 (SK2) selective inhibitor that is nearing enrollment completion of a Phase 2/3 study for severe COVID-19 hospitalized patients. In addition, RHB-107 (upamostat), a once-daily oral serine protease inhibitor, is currently in Phase 2/3 study as a treatment for symptomatic COVID-19.

Key Differentiators

RedHill’s COVID-19 drug candidates set themselves apart from other therapeutic drugs because of four reasons:

1. Dual mechanism of action

The approaches to COVID-19 therapy typically fall into one of two categories — antivirals or immune modulators. Antiviral therapeutics, like remdesivir, aim to prevent the virus from multiplying. Immune modulators modify the immune response and stop it from overreacting dangerously to the viral infection. RedHill’s drugs offer a dual mechanism of action spanning these categories — potentially addressing both the cause and effect of COVID-19.

2. Orally administered

The drugs can be taken orally like any pill. This is especially important for mitigating the complex and expensive systems and procedures needed to distribute and administer monoclonal antibodies or other IV therapies. Moreover, an oral therapeutic that can be more easily used earlier in disease progression could play a significant role in preventing hospitalizations.

3. Forefront in clinical trials

The drugs are being evaluated in Phase 2/3 studies for the treatment of COVID-19 across multiple stages of disease progression and in both a hospitalized and an outpatient setting, covering the largest COVID-19 patient groups. This puts RedHill at the forefront in the global research for oral COVID-19 therapeutics.

Opaganib is in particularly advanced stages. It has demonstrated safety and positive efficacy signals across key primary and secondary endpoints in a completed Phase 2 study in 40 severe COVID-19 patients, as well as promising outcomes from a compassionate use program.

Opaganib’s global Phase 2/3 study in 464 patients is expected to complete enrollment in the coming weeks, following positive outcomes from four data safety-monitoring board (DSMB) reviews.

4. Expected effect against variants

A major concern about vaccines and direct-acting antibodies is their possible lack of efficacy against emerging mutated variants. Contrary to this, RedHill’s drugs target human cell factors involved in viral infection and replication. This is expected to circumvent the potential development of resistance of emerging variants with mutations in the spike protein.

“The world needs a simple, easy-to-distribute and administer, pill-based COVID-19 therapy, and RedHill is at the forefront of research into innovative oral treatments for COVID-19,” said Guy Goldberg, chief business officer of RedHill Biopharma. “If the study is successful, we think the upcoming results from our global Phase 2/3 study of opaganib in hospitalized patients could be an important and underrecognized milestone in the management of the pandemic.”

Pipeline and Programs

RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation (acquired from AstraZeneca), Talicia® for the treatment of Helicobacter pylori (H. pylori) infection and Aemcolo® for the treatment of travelers’ diarrhea.

RedHill’s other key clinical late-stage development programs include:

  • RHB-204 with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease

  • RHB-104 with positive results from a first Phase 3 study for Crohn's disease

  • RHB-102 (Bekinda®) with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D

  • RHB-106, an encapsulated bowel preparation

To learn more about RedHill, visit its website here.

RedHill Biopharma Ltd. is a partner of Benzinga and this content has been provided pursuant to a fee-based agreement between RedHill Biopharma and the publisher. The information in this article does not represent the investment advice of Benzinga or its writers.

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