Jubilant’s oral remdesivir formulation shows positive results in human trial
Jubilant Pharma has announced the successful completion of studies in human volunteers for their oral formulation of remdesivir – an FDA-approved treatment for COVID-19.
The Indian pharma company has now sought authorisation for additional studies for the novel formulation from the Drug Controller General of India.
Remdesivir, made by Gilead, is already available as an injection, but an oral form of the drug may offer a more affordable and convenient form of the therapy. The proposed oral treatment is expected to be for five days, a duration similar to the injectable dosage form.
Remdesivir is the first and the only anti-viral drug fully approved by the US FDA for the treatment of patients with COVID-19 requiring hospitalisation.
Approval was based on the ACTT-1 trial, conducted by the National Institute of Allergy and Infectious Diseases on 1,062 hospitalised patients with mild, moderate and severe COVID-19, who received remdesivir or placebo, plus standard of care. The median time to recovery from COVID-19 was 10 days for the remdesivir group compared to 15 days for the placebo group, a statistically significant difference.
An additional trial also found the odds of a subject’s COVID-19 symptoms improving were statistically significantly higher in a group of patients who’d received remdesivir for five days at Day 11, when compared to those receiving only standard of care.
The new formulation is specifically designed to avoid hepatic metabolism, which would usually result in almost complete first-pass elimination of remdesivir when it is administered by the traditional oral route. The findings from both preclinical and human studies indicate that the drug is able to undergo absorption when administered using the novel oral formulation.
Pramod Yadav, CEO of Jubilant Pharma, said: “We are pleased to announce the ongoing development of a novel formulation of Remdesivir to address the pandemic at this critical juncture. Once approved, this will not only provide a more convenient and easy-to-administer formulation but also support an increasing demand of COVID-19 treatments.”
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