Therapy Areas: Inflammatory Diseases
RedHill Biopharma receives encouraging safety and efficacy data from Opaganib Phase 2 COVID-19 study
4 January 2021 -

Biopharmaceutical company RedHill Biopharma Ltd revealed on Monday that the preliminary data from the US Phase 2 COVID-19 study of 40 hospitalized patients requiring oxygen support show that orally administered opaganib was safe, with no material safety differences between opaganib and control arms and few patients suffered from serious adverse events in the opaganib treatment arm from placebo arm.

The company added that the US Phase 2, randomized, double-blind, placebo-controlled, proof-of-concept study was aimed at assessing safety and identifying preliminary signs of activity. Patients in the study were randomly selected in a 1: 1 ratio to receive either opaganib or placebo in standard of care (SoC) and followed up to 42 days after initiation of treatment. A full data analysis, including viral and inflammatory biomarker analyzes, baseline risk factors and background therapy stratifications of SoC, is expected in the coming weeks.

In addition, the efficacy of opaganib in severe COVID-19 pneumonia is being further explored in the company's global phase 2/3 study at 30 clinical sites in various countries and a first-line data report is expected in the q1 2021. This study is on track to enroll up to 270 patients.

Opaganib, a new chemical entity, is a novel selective sphingosine kinase 2 (SK2) inhibitor that is administered orally, with a unique demonstrated effect of dual anti-inflammatory and antiviral activity that targets a component of the host cell of the viral replication, potentially minimizing the likelihood of viral resistance, according to the company.

The development of opaganib has been supported by grants and contracts from the NCI, BARDA, and the Department of Defense and US FDA's Office for the Development of Orphan Products of the US, concluded the company.