Redhill had hoped that its sphingosine kinase-2 inhibitor opaganib might become one of the first oral therapies for Covid-19. Those hopes are in tatters after the project flunked its phase 3 study in hospitalised patients. The trial did not meet its primary endpoint, the proportion of patients not requiring supplemental oxygen at 14 days with opaganib versus placebo, but Redhill pointed to a subgroup trend, and looks like it might press ahead in patients with earlier disease. The results reinforce that hospitalised Covid is very tough setting: Merck & Co abandoned efforts here with its oral antiviral molnupiravir, although data are due soon from a pivotal trial in Covid outpatients. Redhill, meanwhile, has another oral Covid candidate, RHB-107, in phase 2/3 in non-hospitalised patients. A pill would be handy here given the logistical difficulties in administering intravenous antibodies, a barrier that has contributed to disappointing uptake. If this does not work out Redhill, which had just $72m in cash in June, will have to go back to plan A: its lead project, RHB-204, is in phase 3 for nontuberculous mycobacteria disease. Unimpressed investors sent the group’s stock down 31% this morning.
|Selected antiviral projects in development for Covid-19|
|Opaganib||Redhill Biopharma||Failed ph3 in hospitalised pts|
|Molnupiravir (MK-4482)||Merck & Co/Ridgeback||Company discontinued Move-In in hospitalised pts; data from Move-Out in outpatients due Oct 2021; data from Move-Ahead in post-exposure prophylaxis due H1 2022|
|PF-07321332||Pfizer||Ph2/3 in high-risk & low-risk outpatients complete Oct 2021|
|AT-527||Roche/Atea||Ph2 data in hospitalised pts released Jun 2021; data from ph3 Morningsky in outpatients due end 2021|
|RHB-107 (upamostat)||Redhill Biopharma||Ph2/3 in outpatients completes Sep 2022|
|Source: Evaluate Pharma & clinicaltrials.gov.|