Tiziana Life Sciences PLC (NASDAQ:TLSA, LON:TILS) said top-line data will be available later this month from its recently-completed clinical trial in COVID-19 patients that received its nasally-administered monoclonal antibody, Foralumab.
Anecdotal feedback from the Brazil study, carried out in collaboration with the Harvard Medical School and Santa Casa de Misericordia de Santos Hospital, was “positive and suggests that the treatment was well-tolerated”, the company said.
Tiziana added that the scientific approaches used “could potentially be effective against SARs, MERS, and all variants of coronaviruses”.
“Nasal administration of Foralumab to modulate the human immune system is a potentially transformative approach for treating patients with a variety of human diseases with dysregulated immune systems,” said Harvard professor Howard Weiner, who is chairman of Tiziana’s scientific advisory committee.
The trial enrolled 39 patients with moderate-to-severe COVID-19 who did not require the use of a ventilator at the beginning of the process.
There were three groups: a control and two others – one that received Foralumab on its own and a ‘cohort’ that was administered the Tiziana drug and dexamethasone, a corticosteroid used for its anti-inflammatory and immunosuppressant effects.
The primary aim of the study was to assess the safety of the Foralumab.
Dr Kimble Matos, the lead coordinating physician, said: “The observations made during the clinical study did not show any adverse events.”
The secondary goal was to evaluate the effect of treatment on disease severity symptoms, nasal tolerance, sense of smell, and biomarkers for disease progression.
The pharmacokinetics (what the drug does to the body) will also be assessed, while patient-reported responses related to COVID-19 symptoms will be collected.
“While we expect to get the top-line data in January 2021, we are delighted with the positive feedback received from the treated patients,” said Dr Kunwar Shailubhai, Tiziana’s chief executive and chief scientific officer.
Nasally administered Foralumab, a fully human monoclonal antibody, is thought to work by improving the immune system by stimulating the body’s regulatory T cells.
It is also believed to dampen cytotoxic (harmful) T cell responses in the nasal and respiratory tract, the primary sites of the COVID-19 virus.
“We believe this approach could potentially provide benefits to patients already infected with COVID-19 and its newly identified variants,” said Shailubhai.
“Thus, our therapeutic approach to provide rapid relief to patients already suffering with the diseases is particularly important, because vaccination is primarily to prevent COVID-19 infection, but it may not be useful for the treatment of COVID-19 patients.”