Glenmark Pharmaceuticals Ltd on Wednesday said the top-line results of its phase 3 clinical trials for favipiravir to treat covid-19 patients with mild to moderate symptoms, showed 40% faster recovery compared to those on standard supportive care.
Recovery from symptoms, such as fever, respiratory rate, oxygen saturation and cough, were secondary outcome of the trial conducted on 150 patients. The primary outcome was the time taken to “stop oral shedding of the virus".
The results, which have not yet been peer-reviewed, showed that viral clearance, or the time taken for oral shedding to stop, was 28.6% faster among patients who were administered favipiravir. Besides, 69.8% patients treated with favipiravir treatment arm achieved clinical cure by the fourth day, compared to 44.9% observed in the control arm. Glenmark said it plans to submit the clinical trial data for publication in a peer-reviewed journal in the coming weeks.
Favipiravir also delayed the onset of more severe symptoms such as breathlessness. Among the patients whose condition deteriorated, those on favipiravir took a median time of five days to require oxygen support, while those in the control arm deteriorated in about two days, the company claimed.
“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 (acute respiratory distress syndrome) and mortality," Monika Tandon, Glenmark’s vice president and head of clinical development for global specialty branded portfolio, said in a statement.
However, the use of favipiravir also led to more adverse events (AEs), with 26 of the 75 patients receiving favipiravir showing side effects, compared to six patients in the control arm. Glenmark said “most AEs were mild to moderate and none led to drug discontinuation or dosing adjustments". The most-commonly observed AE was asymptomatic transient increases in uric acid, it added.
In June, the Central Drugs Standards Control Organisation, headed by V.G. Somani, had given emergency use authorisation for favipiravir to treat covid-19 patients with mild and moderate symptoms, following randomised, open-label the phase 3 study. However, Glenmark came under severe criticism for not making the trial data public.
