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India-based Glenmark Pharmaceuticals has reported positive top-line data from a Phase III clinical trial of its favipiravir generic FabiFlu to treat mild to moderate Covid-19.
The open-label, randomised, multi-centre trial assessed the safety and efficacy of FabiFlu plus standard supportive care compared to standard supportive care alone in a total of 150 patients at seven sites across India.
Favipiravir is a broad spectrum antiviral medication known to selectively block RNA-dependent RNA polymerase (RdRp) and SARS-CoV-2 viral replication phase.
Trial participants in the favipiravir arm received a 3,600mg dose on day one, followed by 1,600mg for up to 14 days, along with standard supportive care.
Data revealed numerical improvements on the primary efficacy endpoint. A 28.6% faster viral clearance was observed in the overall population on Glenmark’s treatment versus those in the control group.
Results also showed a statistically significant faster time to clinical improvement.
On key secondary outcomes for clinical improvement, favipiravir demonstrated a 40% faster ‘clinical cure’, defined as normalisation of clinical signs with a statistically significant decrease in median time to clinical cure.
According to the data, 69.8% of participants in the favipiravir arm experienced clinical cure by day four, a statistical significance compared to 44.9% in the control group.
In addition, patients who clinically deteriorated and needed oxygen support had a longer median time of five days to first time use of oxygen when treated with the drug, compared to two days with standard supportive care alone.
Favipiravir was found to be well-tolerated without any serious adverse events (SAEs) or deaths. Adverse events (AEs) occurred in 26 patients on favipiravir compared to six in the control arm, but most AEs were reported to be mild to moderate.
Glenmark Global Specialty/Branded Portfolio clinical development vice-president and head Dr Monika Tandon said: “We are encouraged with the top-line results and these indicate that early treatment with favipiravir may improve clinical outcomes for mild to moderate patients and could potentially prevent patients from progressing to ARDS and mortality.”
The company started Phase III trials of favipiravir as a potential treatment for Covid-19 patients in India in May.