Tiziana Life Sciences (LSE:TILS) stock is soaring after it reported positive results from clinical trials of its nasal antibody treatment for Covid-19.
Shares in the UK biotech were up more than 20% in early Tuesday trading.
CEO Dr Kunwar Shaiubhai hailed the data from the clinical study of Formulab in Covid-19 patients in Brazil.
Results (pictured below) from CT scans of the lungs in severely-affected Covid-19 patients treated with the monoclonal antibody drug showed double the lung function improvement compared to control groups, as well as large reductions in the c-reactive protein and the Interleukin-6 cytokine which indicate inflammation.
|Cohort (evaluable patients||Lung CT Scan (% Improvement)||Cytokine IL-6 (% Reduction)||C-Reactive Protein (% Reduction)|
|Foralumab + Dexa (n=12)||75||41||55|
Those who received Formulab also showed a more rapid recovery from the after effects of coronavirus infection, including improved smell and taste, compared to a control group.
Because the drug’s anti-inflammatory effects come from modulating the human immune system, instead of simply targeting the disease, Formulab could also be useful in treating dangerous Covid-19 mutations identified in the UK, South Africa, and Brazil, Dr Shaiubhai said.
Covid-19 mutations are making the fight against the pandemic much more difficult, as some vaccines are not set up to treat new developments in the novel coronavirus. The B117 mutation that first appeared in the UK, for example, is thought to be 50% more transmissible than the original form of SARS-COV-2.
The clinical data “demonstrates the safety of nasally administered Foralumab”, said Dr Shailubhai, as well as providing evidence of its anti-inflammatory effects. This will support the company’s upcoming Phase 2 clinical study with nasally-administered Foralumab in patients with secondary progressive multiple sclerosis.
Formulab is the first monoclonal antibody that can be delivered through the nose or mouth because of its ability to alter the body’s immune response through the respiratory tract in the nose, throat in the human gut.
Dr Shailubhai added: “We are delighted with the promising clinical data showing evidence of the positive effect of nasally administered Foralumab in Covid-19 mediated pulmonary and systemic inflammation.
“This is a first-in-class and scientifically logical approach to modulate the host immune system to fight the inflammatory reaction to SARS-CoV2 (Covid-19 virus).“
Patients received the proprietary fully human anti-CD3 monoclonal antibody on its own, as well as combined with the corticosteroid dexamethasone. Then the results were compared to a control group.
TILS lead scientist Dr Thais Moreira,who co-ordinated the clinical trial, said:
“We are delighted to see that patients treated with nasally administered Foralumab showed a positive trend in the reduction of lung inflammation, and supportive data indicating significant reduction in cytokine IL-6 and C-reactive protein. In addition, there are indications from patients who reported that treatment with Foralumab rapidly improved the smell and taste sensations that are frequently lost with severity of COVID-19 disease“.
TILS is jointly listed on London’s AIM market and on the tech-focused NASDAQ in the US.