Tiziana Life Sciences pulls the trigger on phase II Covid trial after appointing a contract research group

Tiziana Life Sciences PLC (NASDAQTLSA, LON:TILS) said it has signed a deal with contract research group FHI Clinical to carry out a phase II, proof-of-concept study on its nasally-administered antibody treatment for Covid. Foralumab will be given to hospitalised patients with severe coronavirus as part of the Brazil trial that will build on earlier work in mild-to-moderate cases which confirmed the safety and tolerability of the drug as well as its potential efficacy. Researchers will carry out a randomised, placebo-controlled, double-blind assessment of the treatment, which means they won’t know which patients received the antibody, and who got the placebo until the end of the process. “We are pleased to move forward on our next COVID-19 trial,” said Tiziana chief medical officer, Neil Graham. “After a successful proof-of-mechanism trial in mild to moderate COVID-19 outpatients with intranasal Foralumab earlier this year, the next step is to test it in more severe hospitalized patients with pulmonary inflammation." FHI, meanwhile, has extensive international experience in clinical trials of drugs for infectious diseases. "Our experience is uniquely suited to the needs of this Phase 2 study as we are able to pull from past outbreak experience, including rapid study start-up in research-naïve areas to leveraging existing global research networks and contributing to local health systems," said Ted FitzGerald, its chief executive. "We excel at addressing the complex aspects of infectious disease trials that require thorough planning and contingency planning."