UK Regulators Approve Phase 2/3 Study of Opaganib for COVID-19

Opaganib is set to be evaluated against coronavirus disease 2019 (COVID-19) in a multi-center, randomized, parallel arm, double-blind, placebo-controlled study. The approval was granted by the UK Medicines & Healthcare products Regulatory Agency (MHRA), according to RedHill Biopharma.

Opaganib is a first-in-class SK2 selective inhibitor intended for exploration in multiple indications. The therapeutic is also included in ongoing Phase 2 studies for prostate cancer and cholangiocarcinoma. Opaganib is orally administered and has possible anticancer, anti-inflammatory and anti-viral action. By inhibiting SK2, opaganib impacts cellular pathways associated with viral replication, cancer growth, and inflammation.

The upcoming study will enroll 270 patients with severe SARS-CoV-2 infection. RedHill has submitted applications for the study to other health agencies in Russia, Italy, and elsewhere. It is intended to take place across about 40 clinical sites.

The United States also approved a parallel study, in up to 40 patients with severe COVID-19.

Patients qualify if they are undergoing severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Participants will be randomized in a 1:1 ratio to receive either opaganib or placebo, along with standard-of-care therapy.

An unblinded futility only interim analysis will be conducted by an independent data safety monitoring board. The primary endpoint is the proportion of patients who need intubation and mechanical ventilation on Day 14.

“This timely approval from the UK regulatory authority for the Phase 2/3 study with opaganib comes as the global infection rates continue to grow and there remains a serious unmet medical need for a safe and effective treatment for COVID-19. We are rapidly advancing our COVID-19 program with opaganib, including the recently initiated Phase 2a study in leading U.S. centers,” said Mark L. Levitt, MD, PhD., Medical Director at RedHill, in the approval announcement.

Pre-clinical data have suggested anti-inflammatory and anti-viral activities of opaganib, with the potential to reduce lung inflammatory disorders.

“Several prior pre-clinical studies support the potential role of SK2 in the replication-transcription complex of positive-sense single-stranded RNA viruses, similar to coronavirus, and its inhibition may potentially inhibit viral replication. Pre-clinical in vivo studies have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids,” RedHill stated.