RedHill Biopharma Ltd. [NASDAQ: RDHL] disclosed introductory prime-line data from the 475-victim global Phase 2/3 study with opaganib in hospitalized victims with serious COVID-19 pneumonia. The firm has revealed that unfortunately, its trial for COVID-19 remains unsuccessful as it did not reach the initial endpoint.
RedHill revealed that the research has confirmed that the study of opaganib arm vs. placebo did not reach the multiple endpoints, involving the primary endpoint, even though not reaching analytical significance. Top-line safety data demonstrated good tolerability of opaganib, with balanced adverse reactions between the study arms.
Shares of RedHill Biopharma Ltd. [NASDAQ: RDHL] plunged -35% during the pre-market trading session of Tuesday. RedHill has thanked the team, volunteers, physicians for the support during the trial and also shown the disappointment for not achieving statistical significance.
The study was a multicenter, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study. A total of 475 participants has taken part in the study with severe COVID-19 pneumonia needing hospitalization and cure with supplemental oxygen. It has been disclosed that analysis of the top-line data is continuing, including an evaluation of the potential for the enhanced benefit of the cure with opaganib in sufferers at earlier stages of the disease.
Furthermore, RedHill disclosed that it has decided to share the data with officials, including U.S. FDA and foreign regulators, to help decide the next steps. Additionally, the top-line outcomes from the Phase 2/3 study of the firm with opaganib are initial in nature, as they are based exclusively on top-line information presented to the firm by an autonomous third-party contractor.