Tiziana Life Sciences to launch phase 2 trial of Foralumab in Covid-19

Tiziana Life Sciences said that it plans to launch a phase 2 clinical trial to evaluate the nasal administration of Foralumab in moderate to severe Covid-19 patients.

Foralumab is an anti-CD3 human monoclonal antibody developed by the UK-based biotech company.

Tiziana Life Sciences said that a recently held clinical study in mild to moderate Covid-19 patients gave evidence that the nasally administered antibody brought down pulmonary and systemic inflammation and was well tolerated.

The early-stage study was conducted in collaboration with scientific teams at the Harvard Medical School in Boston, US, and INTRIALS, a Latin American CRO based in Brazil.

Tiziana Life Sciences intends to undertake a phase 2 randomized, placebo-controlled trial in Brazil in moderate to severe hospitalized Covid-19 patients to assess Foralumab in a more compromised group.

All patients in the mid-stage trial will be given standard of care background therapy, said the British biotech company.

According to Tiziana Life Sciences, nasal treatment with Foralumab can modulate the immune system and help in triggering regulatory T-cells (Tregs) for the treatment of Covid-19.

Dr Neil Graham – Chief Medical Officer at Tiziana Life Sciences said: “We are  excited about this next important step in our goal to validate our drug candidate and our novel delivery system as a promising and innovative approach to immunomodulatory therapy for Covid-19 and other mutant variants.

“By focusing on moderating the inflammatory consequences of the SARS CoV2 virus, we hope to have a therapy that has efficacy irrespective of local viral variants.”