SEVERE ACUTE RESPIRATORY INFECTIONS: COVA CLINICAL PROGRAMME
1. Respiratory infections such as Covid-19 cause many hospital admissions and deaths
According to the World Health Organisation (WHO), viral respiratory infections kill thousands of patients worldwide every year. In 2023, more than 230,000 patients died from COVID-19, out of a total of almost 7 million since the start of the pandemic. These figures are not likely to fall any time soon, as major environmental factors such as urban lifestyles and travel continue to encourage the spread of the virus and the virus remains changing and thereby escaping effects of vaccination and acquired immunity from prior infection. There remains a risk that a highly virulent strain may appear that may lead to future hospitalization and mortality waves.
The majority of infected people who are now reaching the severe and/or critical stage of the disease are frail, elderly, suffering from co-morbidities or immunocompromised. They are more difficult to treat, and more than 17% of them continue to die in hospital.
2. Biophytis has achieved promising phase 2/3 clinical results
The RUVEMBRI™ drug candidate developed by Biophytis acts on the respiratory capacity of patients with severe stage infection. In 2024, Biophytis published positive final results for its Phase 2/3 clinical trial that included 238 patients and in which RUVEMBRI™ showed a significant 44% reduction in the risk of death or respiratory failure versus placebo in patients with severe symptoms related to COVID-19 infections.
3. Biophytis aims for market access
Biophytis aims to obtain early access to its drug candidate in the coming months. To this end, filings will be submitted in the coming months.
The company also intends to explore the potential of its drug candidate for the treatment of other viral infections, such as seasonal influenza. The initiation of a Phase 3 study to expand the indication of RUVEMBRI™ will depend on the conclusion of agreements with pharmaceutical partners. Biophytis aims to initiate this study as soon as possible.