RedHill Biopharma making rapid progress on COVID-19 Ph II/III program, says analyst

Israel’s RedHill Biopharma’s (Nasdaq: RDHL) COVID-19 program is progressing well with two clinical trials ongoing, a Phase II study (n=40) in the USA and an international Phase II/III study (n=270). If results are promising, RedHill plans to apply for emergency use authorization as soon as possible, notes Edison Investment Research analyst Jonas Peciulis.

The trials are testing opaganib, a sphingosine kinase-2 inhibitor. Extensive pre-clinical studies describe opaganib’s rather unique mechanism of action. It not only has an anti-viral effect, but can also reduce inflammation in the lungs. This makes it an attractive option in severe COVID-19 cases, where an overactive immune response can worsen the outcomes.

Clinical data from the compassionate use program were particularly intriguing, says Mr Peciulis, as one-third of patients in the control arm received corticosteroids versus none in the opaganib arm (data were collected before the landmark study in the UK showed that corticosteroids significantly improve outcomes). Patients in the opaganib arm showed numerically better outcomes, but these could have been even better considering corticosteroid use in the control arm.