Another small biotech trying to make a play in COVID-19 treatment has hit a brick wall in clinic trials. This time it’s Laurent Pharmaceuticals, which reported that an oral candidate for hospitalized patients was unsuccessful in a midstage trial.
The phase 2 Resolution clinical trial did not meet its primary goal of improving the proportion of patients alive and free of respiratory failure on day 29, Laurent said in a press release. LAU-7b was being examined as an add-on to standard of care. A total of 232 hospitalized patients with moderate, severe or critical COVID-19 were part of the trial.
In the overall trial population, 69.2% were alive and free of respiratory failure at the 29th day in the LAU-7b treated population, compared to 72.2% in the control group.
Laurent said, though, that “a clinically meaningful efficacy signal” was seen when the critically ill patients were removed from the study population. Laurent said this suggests that once a patient has reached respiratory failure, they are too severely ill to benefit from LAU-7b.
The narrowed group of trial patients who were either moderately or severely ill did not have any deaths or progression to mechanical ventilation when treated with LAU-7b and standard of care. In the control arm including this subpopulation, on the other hand, four patients died and five progressed to ventilation.
A clinical investigator on the trial suggested that further clinical testing in a larger moderate-to-severe patient population will confirm the results seen in that patient group. Laurent plans to do just that and will seek guidance from regulatory authorities on how to narrow down to the moderate-to-severe population.
The therapy was well tolerated, with safety similar to the placebo group.
Companies are desperately trying to come up with an oral option for treating COVID-19, a race backed by the U.S. federal government. If Laurent can get some positive results for the oral therapy in the narrowed population, the biotech could find a niche in the treatment of COVID-19.
But the path forward could be rocky, as the pipeline is riddled with failures from companies big and small. RedHill Biopharma recorded a phase 2/3 failure for a COVID-19 treatment earlier this month, as have CytoDyn and Novartis-partnered Mesoblast.