Jubilant Pharma has completed initial tests of its oral remdesivir formulation in healthy volunteers. The progress led Jubilant to seek authorization to run additional studies of its oral twist on Gilead Sciences' intravenous COVID-19 antiviral.
An effective oral antiviral could enable the widespread, early treatment of COVID-19 and thereby stop recently infected individuals from going on to suffer severe disease. However, while Gilead recently completed an early-phase trial of an inhaled remdesivir candidate, efforts to create an oral formulation have been held back by problems including hepatic extraction.
Jubilant has designed its oral remdesivir formulation to avoid the hepatic extraction that leads to the almost complete first-pass clearance of the molecule but is yet to share details of how it has tried to work around the problem.
Researchers have put the formulation through safety and pharmacokinetic studies in animals and healthy volunteers. Jubilant is yet to share data from the studies, saying only that the tests show the drug “is able to undergo absorption when administered using the novel oral formulation” and has a similar safety profile to the injectable formulation. The plan is to give a five-day course of the drug.
Jubilant is confident enough in its results to ask the Indian regulator for authorization to conduct additional studies but is yet to share details of the next steps or the information it is likely to need to generate to support approvals.
News of the progress of the oral formulation comes almost one year after Gilead granted Jubilant the right to sell remdesivir in India and more than 100 other countries. Gilead granted the same rights to several other companies, but India has still faced remdesivir shortages in recent weeks as COVID-19 cases have surged.