- The stock price of Tiziana Life Sciences plc (NASDAQ: TLSA) increased by over 6% pre-market. This is why it happened.
The stock price of Tiziana Life Sciences (NASDAQ: TLSA) – a biotechnology company focused on innovative therapeutics for oncology, neurology, inflammation, and infectious diseases – increased by over 6% pre-market. Investors are responding positively to Tiziana Life Sciences announcing that it signed an agreement with FHI Clinical, a global clinical contract research organization (CRO) to conduct a Phase 2 Proof-of-concept study in Brazil to evaluate the safety, tolerability, and efficacy of intranasal Foralumab in hospitalized patients with severe coronavirus disease 2019 (COVID-19) and pulmonary inflammation.
As a subsidiary of FHI 360, FHI Clinical specializes in the clinical development of drugs for infectious diseases. And the company’s involvement with COVID-19 includes Phase 1 to Phase 3 clinical trials for vaccines and therapeutics as well as observational studies to collect data about the characteristics and course of infection. With experience conducting related studies across 16 countries and 43 states in the US, FHI Clinical has a large network of clinical sites throughout the world to expedite COVID-19 trials.
In the clinical trial, Foralumab will be delivered intranasally through a metered-dose nasal atomization device. And nasal administration of Foralumab is a highly innovative approach to treat patients with autoimmune diseases where the immune system may be dysregulated. Several studies suggested that there is dysregulation in the immune system of patients with COVID-19.
This randomized, placebo-controlled, double-blind, and proof-of-concept study is designed to expand on the preliminary findings of safety, tolerability and efficacy of intranasal administration of Foralumab observed in mild to moderate non-hospitalized COVID-19 patients. This study will examine attenuation of pulmonary pathology in hospitalized patients with severe COVID-19. And up to 7 sites in Brazil will be engaged to conduct this study. Plus 80 hospitalized patients with severe COVID-19 and evidence of pulmonary involvement on a computed tomography (CT) scan at screening will be enrolled.
The patients will be randomized 1:1 to receive intranasal Foralumab 100 µg. Additionally, the study will also evaluate the effect of Foralumab on the resolution of symptoms by chest CT, inflammatory biomarkers, T-cell subpopulations, safety, and mucosal inflammatory response following 14 days of intranasal administration.
“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. We excel at addressing the complex aspects of infectious disease trials that require thorough planning and contingency planning.”
— Ted FitzGerald, FHI Clinical President and CEO
“We are pleased to move forward with FHI Clinical on our next COVID-19 trial. 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.”
— Dr. Neil Graham, Chief Medical Officer at Tiziana Life Sciences
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.