RedHill Biopharma expands U.S. partnerships for opaganib manufacturing amid COVID-19 fight

Israeli biopharma company RedHill Biopharma has significantly advanced its efforts to combat COVID-19 by forging strategic partnerships with two U.S.-based manufacturers. These collaborations aim to scale up the production of opaganib, a promising drug candidate designed to treat severe COVID-19 pneumonia. With the world still grappling with the pandemic, RedHill’s proactive approach underscores its commitment to meeting potential emergency use demands for opaganib, which the company anticipates could be filed as early as the first quarter of 2021.

What Is Opaganib and How Does It Work Against COVID-19?

Opaganib is an oral sphingosine kinase-2 (SK2) selective inhibitor developed by RedHill Biopharma. This drug has dual anti-inflammatory and antiviral properties, targeting both the cause and the effects of COVID-19. Opaganib works by interfering with the host cell component involved in viral replication. This approach not only offers potential to reduce viral load but also addresses a critical concern in COVID-19 treatment: the possibility of resistance due to viral mutations. By focusing on cellular mechanisms rather than viral structures, opaganib could offer an innovative solution to combat evolving strains of the virus, especially in severe cases of pneumonia.

RedHill Biopharma’s research suggests that opaganib may help manage inflammation and viral replication simultaneously, a dual action that could be crucial in treating patients suffering from the most severe forms of COVID-19. The drug’s ability to target both aspects of the disease may position it as a key player in the fight against the pandemic, especially as variants continue to challenge existing treatment regimens.

RedHill Biopharma’s Strategic Manufacturing Partnerships

To support the global demand for opaganib, RedHill Biopharma is expanding its manufacturing capabilities. The company’s recent partnerships with U.S.-based manufacturers are part of a broader strategy that also includes collaborations with European and Canadian firms. By diversifying its manufacturing network, RedHill ensures that it will be better positioned to meet the potential global demand for opaganib, should it receive regulatory approval for emergency use.

Reza Fathi, Senior Vice President of R&D at RedHill Biopharma, explained, “We are expanding our U.S.-based manufacturing capacity for orally administered opaganib, ahead of potential emergency use applications as early as Q1/2021. Together with our recently announced similar partnerships in Europe and Canada and in light of our rapidly progressing Phase 2/3 opaganib COVID-19 program, these new U.S. partnerships better place RedHill to meet potential demand for opaganib, if approved.”

These U.S.-based partnerships are particularly crucial as the company seeks to ramp up production capabilities in preparation for a potential surge in demand. With a Phase 2/3 global trial already underway, RedHill’s partnerships will enable the company to meet the logistical challenges of mass production, ensuring that opaganib can be distributed quickly if emergency use authorization is granted.

RedHill Biopharma’s Progress in Clinical Trials

As of now, RedHill has made significant strides in advancing its clinical trials for opaganib. The company’s Phase 2/3 global trial, which involves 270 patients suffering from severe COVID-19 pneumonia, is more than 50% enrolled. This rapid progress is critical as it enables RedHill to gather the data needed for regulatory submissions. The company has also completed enrollment for a parallel Phase 2 study in the U.S., which involved 40 patients.

These clinical studies are central to determining the efficacy of opaganib as a treatment for severe COVID-19 pneumonia. The ongoing trials will provide essential data to support the drug’s potential emergency use applications, with the first quarter of 2021 marking a crucial period for the company’s regulatory strategy.

What Does This Mean for the Future of Opaganib?

RedHill Biopharma’s ongoing work with opaganib demonstrates the company’s commitment to addressing the COVID-19 pandemic through innovative therapeutic solutions. By expanding manufacturing capacity and advancing clinical trials, RedHill is positioning opaganib as a potential game-changer in the treatment of severe COVID-19 pneumonia. As the pandemic continues to evolve, the importance of developing treatments that can keep pace with viral mutations and patient needs has never been greater.

If opaganib proves successful in clinical trials and receives emergency use authorization, it could become a crucial tool in managing severe COVID-19 cases, particularly for patients who are unresponsive to current treatments. The company’s diverse network of manufacturing partnerships will ensure that, should the drug be approved, it can be produced and distributed efficiently to meet global demand.

RedHill Biopharma’s efforts to expand its U.S.-based manufacturing partnerships for opaganib are a key step forward in its mission to provide a novel solution to severe COVID-19 pneumonia. With the company’s rapid progress in clinical trials and strategic manufacturing collaborations, opaganib is positioned to be a significant player in the global fight against COVID-19. As the world awaits further data, RedHill’s proactive approach ensures that it will be ready to meet the demand for this promising treatment, potentially transforming the landscape of COVID-19 care.